cyrilzakka/clinical-trials huggingface dataset:
Prevalence of Antiphospholipid Antibodies in the Hemodialysis Patients Population Within the CHU Brugmann Hospital

In patients with a chronic renal disease at the terminal stage, extrarenal epuration is essential for the control of clinico-biological complications. Two extrarenal epuration techniques are currently available: peritoneal dialysis (using the peritoneal membrane of the patient) and hemodialysis, requiring the use of an external biocompatible membrane known as 'dialysis filter'. This technique requires a vascular access (arteriovenous fistula or dialysis catheter). The thrombosis of vascular accesses represents a major cause of morbidity and mortality in hemodialysis patients. Thrombosis are more frequent when using synthetic prosthetic arteriovenous fistula instead of native arteriovenous fistula.

Antiphospholipid Syndrome (APLS) is a rare autoimmune disease characterized by arterial thrombosis, venous thrombosis and obstetrical complications such as as defined by the Sidney's criteria.

In the general population, the presence of antiphospholipid antibodies is associated with an increased risk of thromboembolic events. In the nephrological population, this prevalence is higher in hemodialysis patients compared to patients on peritoneal dialysis or non-dialyzed patients. Up to 37% of hemodialysis patients are positive for antiphospholipid antibodies and this biology is associated with thrombotic events and vascular access thromboses. However, some studies do not report this association and there is currently no consensus in terms of the therapeutic management of these patients.

Some factors influencing the positivity for antiphospholipid antibodies have been reported: smoking, age, the presence of a non-glomerular nephropathy, hypoalbuminaemia, the use of a central venous catheter for dialysis or the use of a non-biocompatible dialysis membrane.

Taking into account the conflicting data from the literature, it seems important to study the respective role(s) of 3 types of antiphospholipid antibodies in the occurrence of thrombo- embolic events in patients undergoing dialysis within the CHU Brugmann Hospital.


Eligibility Criteria:
Inclusion Criteria:

- All patients undergoing dialysis within the CHU Brugmann Hospital

Exclusion Criteria:

* Mutation of factor V
* Mutation G20210A of the prothrombin gene
* Protein C deficiency
* Protein S deficiency
* Antithrombin III deficiency
Clinical Value of Next Generation Sequencing in Endocrine Therapy for Advanced Hormone Receptor Positive/HER-2 Negative Breast Cancer

To determine the landscape of gene mutation before and after endocrine therapy, to search for molecular markers of endocrine therapy efficacy, and to explore the clinical value of using NGS detection of ctDNA to guide precise endocrine therapy in patients with advanced breast cancer. The primary endpoints were progression-free survival (PFS), and the secondary endpoints included overall survival time (OS), adverse events (AE), and severe adverse events (SAE).

Before treatment, the patients in the study group underwent NGS detection of ctDNA and formulated treatment plan according to the test results: 1) those with ESR1 mutation and who did not use fulvestrant before, preferred fulvestrant; 2) those with abnormal activation of PI3K/Akt/mTOR pathway signal, preferred mTOR inhibitor combined with endocrine therapy; 3) those with HER-2 sensitive point mutation, preferred anti-HER-2 therapy combined with endocrine therapy; 4) PDGFR mutation, preferential use of PDGFR inhibitors combined with endocrine therapy; 5) no significant gene mutation, making endocrine therapy plan according to the actual clinical situation. After 2 months of endocrine therapy, all patients underwent NGS detection of ctDNA, and the efficacy was evaluated according to RECIST v1.1 standard. If the efficacy evaluation is effective, continue the current treatment and re-evaluate the efficacy every two months; if the efficacy evaluation is ineffective (progress), then withdraw from this study. The vital signs, blood routine, liver and kidney functions and imaging examinations were examined at least every two months in the patients in the study group, and the curative effect was evaluated according to RECIST v1.1 standard.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years, female；
2. Pathologically and immunohistochemically confirmed ER-positive/HER-2-negative patients with advanced breast cancer；
3. According to RECIST standard, lesions can be measured (primary lesion length \> 1.0 cm or lymph node diameter \> 1.5 cm)；
4. Previous endocrine therapy resistance, preparation for second-or-above-line endocrine therapy；
5. No visceral crisis；
6. ECOG PS score: 0-2 points;
7. Laboratory criteria:

   ① white blood cells were more than 4 x 109 /L, and neutrophil count (ANC) was more than 1.5 x 109 /L.

   ② platelet (\>100 \*109/L); hemoglobin (\>10g/dL); serum creatinine (\<1.5 \*normal value) upper limit (ULN); aspartate aminotransferase (AST) (\<2.5 \*ULN); alanine aminotransferase (ALT) (\<2.5 \*ULN); total bilirubin (\<1.5 \*ULN); serum creatinine (\<1.5 \*ULN);
8. the volunteers voluntarily joined the study, signed informed consent, and had good compliance and follow-up.

Exclusion Criteria:

1. Pregnant or lactation woman
2. With mental disease
3. With severe infection or active gastrointestinal ulcers
4. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
5. taking part or participating in other clinical trials within one month.
Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Autism Spectrum Disorder

To study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of autism spectrum disorder.

This is a Phase 1 clinical trial that constitutes two time points cohorts with participants who will receive intravenous autologous umbilical cord blood and 0.9% sodium chloride respectively. The timing of treatment is any time after the diagnosis of autism spectrum disorder. The investigator will proceed the groups during the same period.

1. Demographic Data and Baseline Characteristics of the Studied Group were collected:

   * Basic patient's information survey
   * Medical history
   * Physical examination
   * Basic blood test result
   * Autism Behavior Checklist,CARS before the treatment
   * Brain Magnetic Resonance Imaging-Diffusion Tensor Imaging (MRIDTI) before the treatment
   * Neurocognitive function test before the treatment
2. Assessment of clinical condition in the course by measurement of blood pressure, heart and respiratory rates, temperature and adverse events was recorded.
3. Autologous cord blood doses is 20-30ml (total Mononuclear cells# 1\*10\^7/kg)#the infusion speed is 1ml/min, and with same volume of 0.9% sodium chloride as placebo.
4. The follow-up: clinical test until 24th month in 3 month gaps.

Eligibility Criteria:
Inclusion Criteria:

* • A patient who was diagnosed with ASD.

Exclusion Criteria:

* • In case a patient underwent a surgical procedure, or was administered autologous cord blood within one year before participating in a clinical trial.

  * Accompanied by a serious disease, such as chromosome abnormality, etc.
  * In case where a patient's medical condition is judged to be maladapted by a researcher.
  * In case a patient or his or her legal representative doesn't agree to participation in a clinical trial.
  * A patient having a predisposition to allergies.
  * A patient having serious disorders in the liver, kidney, and cardiopulmonary function.
Comparison of Intravitreal Ranibizumab and Macular Laser Photocoagulation for ME Following Branch Retinal Vein Occlusion (BRVO)

This study is designed to evaluate the efficacy of intravitreal Ranibizumab in comparison with macular laser photocoagulation as treatments for macular edema secondary to branch retinal vein occlusion.

Characteristics of this study is as below

1. Multicenter, randomized clinical trial. (intravitreal Ranibizumab 0.5mg injection vs. macular laser photocoagulation)
2. After 48 weeks follow up, functional change(visual acuity)and anatomical change (central retinal thickness) would be evaluated


Eligibility Criteria:
Inclusion Criteria:

* Symptom duration \< 6 Months, \> 4 weeks
* Visual acuity - less than 20/40 (73 letters) more than 20/400 (19 letters) in ETDRS chart
* OCT - center involved retinal thickening : \> 250 micrometers
* clear media
* well controlled hypertension (\<140/90mmHg) and diabetes (6.5\<HbA1c\<9.5)
* willing to return for all scheduled visits

Exclusion Criteria:

* uveitis,NVG, exudative AMD, diabetic retinopathy, Irvine-Gass syndrome, OIS
* any malignancy
* previous treatment history - laser photocoagulation, intravitreal injection with any drug, vitrectomy
* vitreomacular traction or epiretinal membrane
* intraocular surgery in the study eye within 6 months
* uncontrolled glaucoma ( \> 30mmHg with anti-glaucoma medications)
* optic neuropathy, amblyopia
* A condition that in the opinion of the investigator would preclude a patient's participation in the study
Patient-Reported Outcome Measures in Wild-Type and Variant Cardiac Transthyretin Amyloidosis

Specific, standardized, comprehensive, universally accepted Patient-Reported Outcome Measures (PROMs) are currently lacking for variant and wild-type cardiac amyloid transthyretin amyloidosis (v-ATTR/wt-ATTR). Our goal is then to create two scores able to provide a cumulative assessment of cardiac involvement, peripheral neuropathy (in v-ATTR), and comorbidities, and their impact on the quality of life.

In the setting of a nationwide collaboration involving 5 main Italian referral centers for this condition (in Ferrara, Florence, Pavia, Pisa and Messina), a panel will be created, including experts of ATTR cardiomyopathy, neurologists, geriatricians, health management specialists, as well as patients with either variant or wild-type ATTR cardiomyopathy (n=50).

The most clinically relevant domains for patients (such as physical limitations, symptoms, self-efficacy and knowledge, social interference, quality of life, age-related issues, social and family environment, frailty, comorbidities) will be identified. Two sets of 30 items (one for variant and another for wild-type ATTR cardiomyopathy) will be created in collaboration with patients. Questions will be formatted for gender neutrality, clarity, interpretability, and possible foreign language translations. PROMs scores will be validated through administration to around 250 consecutive outpatients. Score performance will be evaluated in terms of internal consistency, response to clinical changes, comparison with conventional clinical measures. The time needed for completion, the clarity of questions and the need for assistance from a family caregiver will be evaluated.

This project will hopefully lead to the identification of disease-specific metrics that may serve as a clinically meaningful outcome in cardiovascular research, patient management, and quality assessment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cardiomyopathy due to ATTR amyloidosis, diagnosed by endomyocardial biopsy or on the basis of the algorithm for the non-invasive diagnosis of cardiac ATTR amyloidosis (Gillmore et al., 2016).
* Clinical stability, defined as the lack of unscheduled hospitalizations and/or significant changes in cardiac therapies from at least 1 month.

Exclusion Criteria:

* Lack of informed consent.
* Inability of understanding a written text in Italian.
* Absence of the conditions of clinical stability, as defined above.
Heat Therapy and Peripheral Artery Disease

The purpose of the study is to assess the efficacy of a novel 8 week heat therapy intervention in intermittent claudication compared to usual care controls. Participants will be enrolled on a wait-list control randomised trial testing physiological, mechanistic, and health related outcome measures.

70 participants with PAD will be randomised into one of two groups: either wait-list controls (usual care) or heat therapy intervention. The 8 week heat therapy intervention will consist of shoulder depth submersion in a hot tub at \~40°C for three times a week. Time for heating will be graded with aim of \~60 minutes submersion time by the end of the intervention. After 8 weeks the wait-list control group will then enrol onto the heat intervention and heat therapy participants will go back to usual care. The primary outcome measure for the study is improvement in maximum walking distance, pain free walking, and time to onset claudication. This will be measured via a graded exercise test. Secondary outcomes include Quality of life as measured by generic and vascular specific questionnaires (SF-36,VascuQoL and EQ-5D-5L), vascular health measured using ABPI, blood pressure, FMD, PWV, and markers of inflammation, oxidative stress, angiogenesis and vascular remodelling will be assessed from blood samples. All aforementioned outcome measures will be taken at baseline, 8 weeks, and 16 weeks. Physical activity behaviour (measured with an accelerometer) will be monitored 7 days prior to the beginning of the study, 7 days prior heat intervention, and 7 days after heat intervention.

Eligibility Criteria:
Inclusion Criteria:

* • Aged \> 18 years

  * ABPI \< 0.9 at rest or a drop of 20mmHG after exercise testing
  * Diagnosed with IC
  * Able to walk unaided
  * English-speaking and able to follow instructions
  * No previous history of heat syncope
  * Post-Menopausal or not on hormone therapy
  * Able to provide informed consent

Exclusion Criteria:

* • Walking impairment for a reason other than PAD

  * Critical limb ischaemia/rest pain
  * Asymptomatic PAD
  * Active cancer treatment
  * Clinically diagnosed diabetes or those with peripheral neuropathy
  * Recent / frequent heat exposure (e.g., sauna or hot tubs).
  * severe aortic stenosis, unstable angina, recent MI, stroke or TIA
Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore, clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and manageable toxicity profile.

Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group Phase III study is to compare the results in progression-free survival of 2 combination therapies, panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously treated MM whose disease has recurred or progressed.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has a previous diagnosis of multiple myeloma.
2. Patient requires retreatment for multiple myeloma
3. Patient has measurable M component in serum or urine at study screening

Exclusion Criteria:

1. Patient who has progressed under all prior lines of anti MM therapy
2. Patient who has been treated by bortezomib before, and did not reach at least a minor response under this therapy, or progressed under it or within 60 days of last dose
3. Patient has shown intolerance to bortezomib or to dexamethasone or components of these drugs or has any contraindication to one or the other drug , following locally applicable prescribing information
4. Patient received prior treatment with DAC inhibitors including panobinostat
5. Patient has impaired cardiac function, or a prolonged QTc interval at screening ECG
6. Patient taking medications with relative risk of prolonging the QT interval or inducing Torsade de pointes
7. Female patient who is pregnant or breast feeding or with childbearing potential and not willing to use a double method of contraception up to 3 months after the end of study treatment. Male patient who is not willing to use a barrier method of contraception up to 3 months after the end of study treatment.

Other protocol-defined inclusion/exclusion criteria may apply.
Home-based Exercise Program in Patients With the Post-COVID-19 Condition

The management of the sequelae of COVID-19 is described as the next great challenge of global public health. Multiple symptoms may compose the clinical picture of these patients (eg, fatigue, dyspnea, cognitive dysfunction, myalgia and others), persisting for more than a year and frequently causing clinically important functional impairment. Thus, a clinical trial will be conducted to investigate the effects of a remotely supervised home-based exercise program on functional sequelae of patients diagnosed with the post-COVID-19 condition (also known as Long COVID).


Eligibility Criteria:
Inclusion Criteria:

* COVID-19 diagnostic history confirmed by real-time reverse transcription-polymerase chain reaction (RT-PCR) or rapid antigen test (with clinical presentations of moderate to critical severity).
* Diagnosis of post-COVID-19 condition according to World Health Organization criteria.
* Present ≥1 symptoms at study admission, including dyspnea, fatigue, muscle weakness and/or musculoskeletal pain.
* Have internet access at home.

Exclusion Criteria:

* Being under clinical or experimental treatment for the post-COVID-19 condition.
* Any physical disabilities that could hamper physical testing and exercise program.
* Patients with major neuropsychiatric disorders (eg, dementia or severe depression).
* Patients with chronic kidney disease who are in need of hemodialysis.
* Solid organ transplant patients.
* Complex ventricular arrhythmias, atrial fibrillation or complete heart block.
* Recent malignant neoplasm.
* Recent deep venous thromboembolism.
* Acute pulmonary embolism or pulmonary infarction.
* Uncontrolled hypertension.
* Uncontrolled type II diabetes.
* Uncontrolled vestibular disorders.
* Acute infections.
* Pregnancy.
Lifestyle-modifying Interventions in Low-risk MDS Patients

Myelodysplastic syndromes (MDS) are acquired clonal stem cell diseases characterized by hematopoietic cell dysplasia, cytopenia, and the risk of progression to acute myeloid leukemia. In addition to clonal changes in the hematopoietic stem and progenitor cells itself, growing evidence suggests that inflammatory and metabolic changes in the bone marrow microenvironment play an important role in disease development and maintenance of the malignant clone. The positive impact of dietary interventions (e.g. fasting) and physical activity on inflammation and metabolic parameters could be shown in various benign inflammatory disease entities (e.g. atherosclerosis, chronic renal insufficiency, cystic fibrosis etc.).

The aim of this study is to describe the hematological, metabolic, inflammatory, and microbiological changes after combined lifestyle-modifying interventions (outpatient physiotherapy and fasting mimicking diet (FMD) in patients with low-risk MDS.


Eligibility Criteria:
Inclusion Criteria:

1. 18-75 years of age
2. Cytomorphologically confirmed MDS or MDS/MPN according to WHO criteria (incl. MDS-RARS-T, CMML)
3. IPSS-R very low, low, or intermediate
4. Hemoglobin \<11 g/dL (6.8 mmol/l)
5. Non-transfusion dependent (NTD) per IWG 2018 criteria (≤2 blood transfusions within 16 weeks prior to inclusion in the study)
6. ECOG≤2
7. Body mass index (BMI) ≥ 20 kg/m2
8. Written informed consent of the subject after clarification

Exclusion Criteria:

1. AML
2. MDS IPSS-R high or very high
3. History of HSCT
4. MDS-specific drug therapy (including erythropoietin, erythropoiesis-modulating agents, lenalidomide, iron chelation, hypomethylating agents) ongoing or planned in the next 6 months
5. Diabetes mellitus requiring therapy or any other known metabolic disease
6. Application of systemic cortisone-containing drugs
7. Known psychiatric eating disorder (e.g. anorexia nervosa, bulimia)
8. Physical inability to follow the physical and/or nutritive interventions
9. simultaneous participation in another interventional clinical trial (including within the last 4 weeks before inclusion)
10. addictions or other illnesses that do not allow the person concerned to assess the nature and extent of the clinical trial and its possible consequences
11. pregnant or breastfeeding women
12. indications that the subject is unlikely to adhere to the protocol (e.g., lack of compliance)
Soreness After Deep Dry Needling of One Latent Myofascial Trigger Point

Pain after dry needling or injection in the muscle is a frequent secondary effect in the treatment of myofascial pain syndrome. In this trial pain and sensitivity will be assessed during a 72 hours follow up period. Factors that may contribute to higher levels of pain or sensitivity will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

The latent MTrP diagnosis was based upon the following criteria:10

1. presence of a palpable taut band in the muscle
2. presence of a hypersensitive tender spot in the taut band
3. palpable or visible local twitch response with snapping palpation of the tout band
4. referred pain elicitation in response to compression.

Exclusion Criteria:

1. presence of coagulation disorders
2. neck or facial pain
3. previous application of a dry needling technique
4. MTrP therapy in head or neck within the previous 3 months
5. fibromyalgia
6. an insurmountable fear of needles as a reason of refusing the treatment
7. history of surgery in the head or neck area.
Pharmacokinetics/Pharmacodynamics (PK/PD) of Multiple Oral Doses of GLPG0555 in Healthy Subjects

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and to evaluate the relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions of GLPG0555 administered for 3 days. Finally, it is aimed to characterize PK and pharmacodynamics (PD) of GLPG0555 after multiple oral administrations.


Eligibility Criteria:
Inclusion Criteria:

* healthy male, age 18-50 years
* BMI between 18-30 kg/m², inclusive.

Exclusion Criteria:

* significantly abnormal platelet function or coagulopathy
* smoking
* drug or alcohol abuse