cyrilzakka/clinical-trials huggingface dataset:
Observational Study Using the CoVa Monitoring System 3

Asthma is a complex and chronic inflammatory disorder which is associated with reversible airway obstruction and bronchial hyperresponsiveness. It is one of the most prevalent chronic diseases in children and prevalence further increases worldwide. Typical symptoms of asthma are breathlessness, cough, wheezing and chest tightness. These symptoms are particularly prevalent at night-time. Understanding and tracking these symptoms can lead to better management of asthma.

Auscultation using a stethoscope is standard clinical practice, however there is currently no available solution to detect respiratory sounds throughout the day and night.

The aim of this study is to investigate the feasibility of detecting respiratory sounds in healthy children with the CoVa patch.


Eligibility Criteria:
Inclusion Criteria:

* Participant is between the ages of 4 - 17 years old at the time of consent
* Participant and/or family member/carer willing to give written consent
* Participant and/or family member/carer who can read and comprehend english

Exclusion Criteria:

* Subject believed to be unsuitable for inclusion by the Principle Investigator
* Subject is pregnant at time of consent
* Subject is currently enrolled in another medical study
Impact of Mindfulness Intervention on Quality of Life in Patients With Drug-resistant Epilepsy.

This study evaluates a mindfulness intervention in patients with drug resistant epilepsy.

Half of participants will follow a mindfulness programme, while the other half will follow a self management programme.

Drug-resistant epilepsy is associated with an alteration of the quality of life mainly related to psychiatric comorbidities (anxiety and depression). The management of these comorbidities is therefore essential in patients with drug resistant epilepsy, Ideally through non-drug management to minimize the side effects of molecules.

The goal of mindfulness interventions in pathology is to learn to better live with a chronic disease by reducing the stress resulting from the disease, by increasing benevolence towards oneself, the acceptance of the disease and reducing the ruminations linked with the pathology.

Mindfulness therefore seems to be a good way for these patients to improve the management of their emotions and thus improve their quality of life what the investigators propose to evaluate in this study.

The study consists of two phases

1. First phase: comparative randomized study (primary endpoint):

   1. After inclusion, a 2 months baseline follow-up is carry to collect the judgement criteria without intervention.
   2. At the end of this period, patients will be randomly assigned to the mindfulness intervention group or the control group with the psycho educative programme. Both programmes will takes 3 months.
   3. Then a 6-months post-intervention follow-up period for both groups

   Patients will have assessment visits every 3 months. They will also complete a daily notebook including the number of seizures they have done and a scale of their "interior weather".
2. Second phase (optional):

At the end of the first phase, patients in the control group will be able to benefit from the mindfulness programme and will be followed at the end of the programme for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Drug resistant epilepsy according to the criteria of the International League Against Epilepsy (ILAE)
* Stable therapy for at least 3 months
* No planned surgery
* Patient affiliated to social security insurance or beneficiary of social security insurance.
* Signed consent

Exclusion Criteria:

* Patient who has previously had or regularly practicing mindfulness
* Patient with psychogenic non-epileptic seizures
* Pregnant woman, breastfeeding mother, person deprived of liberty by judicial or administrative decision, person subject to legal protection
* Patient with relationship disorders related to psychosis
* Patients who are unable or unwilling to work as a group or person unable to understand the topics discussed during session.
Study To Assess The Pharmacokinetics Of 2 Different Formulations Of PF-04991532

This study is designed to compare the pharmacokinetics of two different lots of tablets.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female (non childbearing potential) subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests. Women must be of non childbearing potential as defined in Lifestyle Guidelines.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
* Screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic), on a single measurement \[confirmed by a single repeat, if necessary\] following at least 5 minutes of rest.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
Reduction of Peritoneal Glucose Uptake With Use of SGLT2 in Humans Undergoing Peritoneal Dialysis Treatment

End stage renal disease is annually diagnosed in about one thousand patients in Denmark, and one of the treatment modalities in renal replacement therapy is peritoneal dialysis with about 25 % of patients assigned to this treatment (Hommel2010). Peritoneal dialysis is based on the principle of filtering waste products to peritoneal fluid and by exchange of peritoneal fluid eliminate waste products from the body.

In peritoneal dialysis commonly used fluids contain glucose. Exposure to high glucose levels in peritoneal fluid during peritoneal dialysis has several side effects. Primarily, as glucose passes over and into the peritoneal membrane it causes local inflammation which leads to fibrosis over time (Zhou2016). Fibrosis limits the capacity of the exchange of water and waste products over the peritoneal membrane. The decrease of peritoneal exchange capacity is most commonly the reason for termination of peritoneal dialysis.

SGLT2-channels are identified in peritoneal mesothelial cells of rats (Debray-Carcia 2016), and most recently also in humans (Shentu2021). An in vitro model of human peritoneal mesothelial cells incubated with the SGLT2-inhibitor (empagliflozin) has shown significantly decrease in glucose uptake (Zhou2019). Exposure to intraperitoneal empagliflozin in rats, reduced the uptake of glucose over the peritoneal membrane significantly by 78 % and the ultrafiltration was increased (Zhou2019).

Currently, to our knowledge, no clinical trials have been conducted in humans attending peritoneal dialysis with the aim of investigating either the effect or safety of SGLT2i, as it is indeed the first of its kind, with the aim of including participants in peritoneal dialysis.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Age above 18 years of age
3. In stable peritoneal dialysis for more than 14 days.

Exclusion Criteria:

1. In treatment with SGLT2i currently or within the last 90 days.
2. Treatment for peritoneal infection within the last 30 days.
3. Any hospitalization within the last 30 days.
4. Anaphylaxis to the IMP.
5. Impaired lever function with ALAT above normal range within the last 6 month.
6. Sever efflux problems during peritoneal dialysis for the last 14 days, judged by the investigator.
7. Non-menopausal defined as menstruation within the last 12 month without any other medical cause. Only applicable for female participants.
8. Substance abuse, judged by the investigator.
9. Incapable to follow study protocol, judged by the investigator.
10. Previously included in this clinical trial and exposed to the IMP.
11. Included in another clinical trial with exposure to any IMP within the last 30 days.
DISPARITY Study: An Observational Evaluation of Characteristics of Participants in Clinical Studies

The aim of this study is to evaluate whether females are underrepresented in clinical studies in the Departments of Anaesthesia and Intensive Care, Amsterdam UMC, locations AMC and VUmc. The main outcome is Participation Prevalence Ratio (PPR), which means the representation of female/male patients in a study in relation to their representation in the disease population undergoing surgery.

To achieve this, we will use the average proportion of female participants enrolled per study and, in addition, data from the CBS for population benchmarking, determining the proportions of males and females undergoing surgery (elective cardiac and non-cardiac surgery) and the proportions of these populations in an academic hospital.


Eligibility Criteria:
Inclusion criteria:

* various clinical trials, both falling within and outside the scope of the Medical Research Involving Human Subjects Act
* adult patients undergoing various types of medical surgeries.

Exclusion criteria:

. studies which excluded or did not equally approach women beforehand
Root Caries Excavation with Air Water/powder Prophylaxis Device for ART Restorations

The main objective of this RCT is to compare the efficacy of a powder/water jet prophylaxis device and conventional hand excavation in excavating root surface caries, with regard to restoration survival/success in older adults.

The secondary outcome of this RCT is to assess the participants' treatment preferences for the received treatment with regard to the procedures involved and in the invasiveness of the procedures carried out during the ART restoration.


Eligibility Criteria:
Inclusion criteria

* Adults ≥65 years
* Dentinal root caries lesions with no painful symptomology
* Can follow instructions for oral hygiene
* Not dependent for care for their ADLs.

Exclusion criteria:

* Symptomatic carious teeth
* Non-carious attrition, erosion or abrasion cavities
* Periodontally compromised teeth with Grade 3 mobility, and active signs of infections.
* Not willing or able to sign informed consent

Post-hoc exclusion:

* Participant withdraws consent
* Medical reasons.
Clinical Assessment of Dental Implant

Primary Endpoints : The implant survival and success rate of V3 and C1 implants will be compared. Implant success rate will be evaluated by measuring the peri-implant bone remodeling from baseline to 1 year post insertion.

The hypothesis is those implant survival rates of the test (V3) and control group (C1) are similar and that test V3 implant allows less peri-implant bone loss.

Secondary Endpoints : The thickness of hard tissue in the buccal aspect of the V3 and C1 implants will be compared. The bone thickness will be measured in cone beam computerized tomography (CBCT) on the day of implantation, 4 and at one year after the final restoration.

The hypothesis is that V3 implant allows thicker bone dimension in the cervical area.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have voluntarily signed the informed consent form before any study related action
* Age: 18 with one or more missing teeth in the maxillary area, seeking for implant therapy.
* Men/Women
* In good systemic health (ASA I/ II)
* Present with no contra indication against oral surgical interventions
* Patients required replacement of a single missing tooth. The tooth at the implant site(s) must have been extracted or lost at least 12 weeks before the date of implantation.
* At least 10 mm of bone in the vertical dimension
* At least 6 mm of bone in the bucco-lingual dimension.
* No need for bone augmentation procedure in any of the dimensions
* Full mouth plaque score (FMPI) lower or equal than 25%

Exclusion Criteria:

* Autoimmune disease require medical treatment
* Medical conditions requiring prolonged use of steroids
* Use of Bisphosphonate intravenously or more then
* Infection (local or systemic) - patient with gingivitis or active local infection will undergo a medical treatment prior to his entrance to the study, each individual will be evaluated prior to study procedure for suitability, in case of systemic infection the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
* Current pregnancy or breastfeeding women
* Alcoholism or chronically drug abuse
* Immunocompromised patients
* Uncontrolled Diabetes
* Smokers
* Prisoners
Early Versus Late Sustained Low Efficiency Dialysis in Critically Ill Cirrhotics With Septic Shock and Acute Kidney Injury

Consecutive patients with cirrhosis and septic shock with AKI who give written informed consent will be included in this prospective trial. At baseline NT-Pro BNP, urine N-GAL will be done for all patients. A baseline serum blood sample (10 ml) and urine sample will be stored. Septic shock will be defined by the presence of two or more diagnostic criteria for the systemic inflammatory response syndrome, proven or suspected infection with hypotension non-responsive to adequate fluid resuscitation assessed by no evidence of stroke volume variation on flow track and need of a vasopressor to achieve a target mean arterial pressure (MAP) of ≥ 65 mm Hg. A record of CVP, IVC diameter and B-lines on ultrasound lung would also be done. Patients with age less than 18 years, severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD) pregnancy, chronic kidney disease on hemodialysis, patients already meeting emergency criteria for immediate hemodialysis at the time of randomization as specified in the late group, patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit, extremely moribund patients with an expected life expectancy of less than 24 hours, failure to give informed consent from family members.


Eligibility Criteria:
Inclusion Criteria:

- Patients with Cirrhosis with septic shock associated AKI (Acute Kidney Injury) stage 3 AKIN/KDIGO stage 2.

Exclusion Criteria:

* Patients with age less than 18 years
* Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, Coronary Obstructive Pulmonary Disease)
* Pregnancy
* Chronic kidney disease on hemodialysis
* Patients with Hepatorenal Syndrome, post renal obstructive AKI, AKI due to suspected based on history,urinalysis and past clinical records-glomerulonephritis, interstitial nephritis or vasculitis
* Patients already meeting emergency criteria for immediate hemodialysis at the time of randomization as specified in the late group (serum potassium\>6 meq/lt, metabolic acidosis ph\<7.12, acute pulmonary edema, severe volume overload with hypoxemia non-responsive to diuretic treatment)
* Patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit
* Extremely moribund patients with an expected life expectancy of less than 24 hours
* Failure to give informed consent from family members.
* Hemodynamic instability requiring very high dose of vasopressors
Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed DLBCL

This study is to evaluate the efficacy and safety of Lenalidomide plus ICE in the treatment of Refractory and Relapsed DLBCL patients.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven diffuse large B-cell lymphoma. Previously treated with 1, and only 1, chemotherapy regimen including rituximab and anthracycline. Relapse after CR, less than PR or PR to previous treatment.
2. No history of stem cell transplantation.
3. Age between 16-75.
4. ECOG\<3.
5. At least 1 measurable tumor mass.
6. Minimum life expectancy of 3 months.
7. Written informed consent.
8. No history of using Lenalidomide, ifosfamide, carboplatin and etoposide.
9. No uncontrolled CNS involvement by lymphoma:No CNS disease at time of relapse;CNS disease diagnosed at initial presentation allowed provided a complete response for CNS disease was achieved and maintained.

Exclusion Criteria:

1. Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.
2. Clinically significant active infection.
3. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.
4. Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
5. Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
6. Patients who are pregnant or breast-feeding.
7. HIV infection.
Lifestyle Intervention for Patients With Multiple Sclerosis

The LIMS study is an observational study that investigates the effectiveness of an online lifestyle program for patients with multiple sclerosis (MS). The patients will be monitored during 27 months, starting 3 months prior to the start of the lifestyle program.

This study aims to investigate the effect of an online lifestyle program on the impact of multiple sclerosis (MS) on daily functioning. MS patients will participate in the online lifestyle intervention of Voeding Leeft and will complete online questionnaires at 7 time-points: 3 months before the start of the intervention (run-in), before the start of the intervention (baseline), and 3, 6, 12, 18 and 24 months after the start of the intervention. A subsample (n=200) will also take part in measurements through mobile applications. The investigators hypothesize that the lifestyle program will reduce the impact of MS on the patients' daily functioning.

Eligibility Criteria:
Eligibility criteria to participate in the online lifestyle intervention:

Inclusion Criteria:

* MS diagnosis
* Motivated to adapt their lifestyle
* Able to complete online questionnaires by themselves
* Able to do grocery shopping and to (let someone) prepare the meals from the program
* In a subpopulation (n=200): daily use of a smartphone

Exclusion Criteria:

* Not able to participate in an online lifestyle intervention (e.g. not having an email address, laptop/computer, internet)
* An inability to speak or read Dutch
* Vegan diet
* Not willing to eat fish
* BMI \<18.5 and \>35 kg/m2
* Pregnant or breastfeeding
* Diagnosis of an eating disorder or psychiatric disorder (according to the DSM-V criteria)
* History of bariatric surgery
* Another disorder, such as inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis), cardiovascular disease (e.g. severe heart failure), malignancy, diabetes type 1 and 2
* Having previously participated in a lifestyle intervention of Voeding Leeft or currently participating in another lifestyle program or lifestyle study.
* Currently under treatment at a dietician or lifestyle coach
Interventistic Clinical Investigation on the Use of Medical Device in Subjects With Mild-moderate Osteoarticular Pain

Evaluation of the performance and safety of ArToFILL in subjects with mild to moderate osteoarticular pain

Monocenter, prospective, open label, interventional clinical investigation evaluating the performance and safety of 3 intra-articular injections of ArToFILL for the treatment of mild-moderate osteoarticular pain.

Eligibility Criteria:
Inclusion Criteria:

* Patient (males and females) aged between 18 and 84 years (limits included);
* Patient able to understand the nature and purpose of the study, including possible risks and side effects;
* Patient able to provide written Informed Consent, in accordance with good clinical practice and current legislation;
* Pain ≥ 40 mm on the VAS score in the target knee for at least 2 months;
* Patient with knee osteoarthritis assessed radiographically, grade 1 to 3 according to the Kellgren-Lawrence scale (K-L);
* Body Mass Index (BMI) ≤ 35;
* Patient who will benefit from this treatment;
* Patient available for the entire study period;
* Patient able to cooperate and meet the requirements of the clinical investigation plan.

Exclusion Criteria:

* Patient with knee osteoarthritis, assessed radiographically, grade 4 by the K-L scale;
* Patient presenting ongoing inflammation/infection at the level of the joint being investigated;
* Patient with abundant intra-articular effusion;
* Patient with symptoms of viral or bacterial infections or similar;
* Patient with insertion point of the joint infected or in the presence of a skin disease;
* Simultaneous treatment with disinfectants containing quaternary ammonium salts or chlorhexidine;
* Patient with known or potential allergy or hypersensitivity and/or history of allergic reactions to one of the components of the medical device;
* Concomitant treatments with thrombolytic or anticoagulant therapies, for less than 2 weeks prior to the screening visit;
* Intra-articular treatments carried out in the last 3 months (9 months if with products containing hyaluronic acid) of the target joint;
* Topical treatments of the target joint in progress or performed within 1 week of the screening visit;
* Taking NSAIDs and/or paracetamol as rescue treatment for more than two consecutive days;
* Surgical interventions of prosthetic replacement in the target joint;
* Physiotherapy and instrumental physical therapy treatments for the target joint performed in the last 2 weeks prior to the screening visit, and during the study period;
* Participation in another clinical trial within 60 days prior to the screening visit;
* Evidence of severe or uncontrolled systemic disease or any other significant disorder (e.g. haemophilia, bleeding disorders etc.); which do not allow participation in the study or could compromise the results.
* Patients who are pregnant or breastfeeding;
* Subject unable to follow clinical investigation procedures and follow-up visits;
* Any other medical condition which could influence participation in the clinical investigation or compromise its results.
Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)

The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.


Eligibility Criteria:
Key Inclusion Criteria:

Patients with CVID (Common Variable Immunodeficiency) or XLA (X-linked agammaglobulinemia) who:

Participated in the Phase III clinical study with intravenous IgPro10 (study number ZLB03_002CR) at 3- or 4- weekly intervals for 12 months (referred to as 'old' subjects)

OR

Were ≥ 6 years of age, were on other stable intravenous immunoglobulin therapy (200-800 mg IgG per kg body weight) at 3- or 4-week intervals for at least 6 months, AND were interested in participating in the Phase III clinical study with subcutaneous IgPro20 (study number ZLB04_009CR) (referred to as 'new' subjects)

Written informed consent

Key Exclusion Criteria:

Diagnosis of epilepsia

Insulin dependent diabetes

Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs

History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension