cyrilzakka/clinical-trials huggingface dataset:
Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure

To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of 400 mg/day, or to a clinically effective lower dose for an individual patient, improves the tolerability and safety of lacosamide (200 mg to 400 mg/d) as add-on treatment for patients with partial onset epilepsy.

Explanation of acronym: SELF = Safety Efficacy Lacosamide Flexibility


Eligibility Criteria:
Inclusion Criteria:

* Patient has a diagnosis of partial-onset epilepsy with or without secondary generalization
* Currently taking 1 to 3 concomitant marketed antiepileptic drugs
* 18 years and older at study entry

Exclusion Criteria:

* Previous use of lacosamide
* Hypersensitivity to any component of lacosamide
* Patients with partial onset seizures not clearly identifiable
* History of generalized epilepsy
* History of status epilepticus within last 12 months
* Uncountable seizures due to clustering within last 12 weeks
* Non epileptic events, including pseudoseizures, conversion disorder that could be confused with seizures
* History of drug or alcohol abuse
* History of suicide attempt
* Progressive cerebral disease
* Concomitant treatment of felbamate
* Prior or concomitant vigabatrin use
* Under legal protection
A Study of Autologous Induced Islet Body With Type 1 Diabetes

This is a single centre、single arm、open-label study，to investigate the safety and efficacy of Autologous induced islet body With Type 1 diabetes


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 to 70 years old (including 18 and 70 years old)
2. Diagnosed as type I diabetes, the diagnostic criteria refer to the 1990 WHO diabetes diagnostic criteria:

（1）Diabetes symptoms (hyperglycemia caused by polydipsia, polyphagia, weight loss, itchy skin, blurred vision and other acute metabolic disorders) + random blood glucose ≥ 11.1nmol / L; （2）Fasting blood glucose ≥7.0mmol/L or 75g glucose meets 2-hour blood glucose ≥11.1mmol/L.

3、Voluntary informed consent is given, agree to follow the trial treatment and visit plan.

Note: 2 is the venous plasma glucose level, if there is no diabetes symptoms, it is necessary to repeat the test on the next day.

Exclusion Criteria:

1. Patients with acute complications of diabetes: including diabetic ketosis, diabetic ketoacidosis, diabetes, hyperglycemia, hypertonic state, etc.
2. Patients with Severe bacterial and viral infections
3. patients are participating in other clinical trials and treating with other immune cellular products (DC, CIK, T, NK, and Car T products with CD19 or other targets)
4. Patients with severe cardiovascular and cerebrovascular disease (NYHA class 3-4) cannot cooperate with the study
5. Patients with severe liver dysfunction(liver function AST and ALT exceeded 2.5 times the normal upper limit).
6. Patients with kidney disease or moderate to severe renal insufficiency (renal function eGFR \<60 ml/min/1.73 m2)
7. Women in pregnancy (urine/blood pregnancy test positive) or lactation; men or women with pregnancy plans in the last year; patients are not guaranteed to take effective contraceptive measures during the trial;
8. patients were diagnosed as tumor or tumor chemotherapy, radiotherapy and acute uric acid nephropathy within 5 years.
9. Other circumstances that researchers do not consider suitable for research.
10. Withdrawal from trial, loss of follow-up or death due to other reasons
11. Incomplete data, affecting effectiveness and safety judges
12. Researchers believe that the need for termination of the trial is needed.
Zevalin Twice in Aggressive Non-Hodgkin Lymphoma

Despite of the availability of treatment for this disease, this study is justified because no known therapies are really curative and it is necessary to look for new treatment options to improve the clinical outcome and prognosis of relapsed aggressive lymphoma. This study is designed for patients not eligible for high-dose chemotherapy and autologous stem cells transplantation.

The objectives of this study are to evaluate the efficacy and safety of two sequential doses of 90Y-Ibritumomab Tiuxetan administered after salvage chemotherapy in patients with relapsed/refractory aggressive lymphoma non-eligible for HDC and ASCT.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75
2. Diagnosis of CD20+ B-diffuse large cell de novo or transformed or follicular lymphoma grade IIIb
3. Stage II, III, IV according to Ann Arbor criteria
4. Chemoresistant disease after first line treatment (CHOP-like + Rituximab) or relapsed patients after one or two lines of chemotherapy not-eligible for high dose chemotherapy and autologous stem cell transplantation
5. Performance status 0-2 according to WHO criteria
6. HIV negativity
7. Normal liver, lung and kidney function: conjugated bilirubin up to 2 x ULN, alkaline phosphatase and transaminases up to 2 x ULN, creatinine clearances ≥45 ml/min
8. Neutrophils count ³ 1.5 x 109/l, Haemoglobin ³ 9 g/dl, Platelets ³ 150 x 109/l and bone marrow involvement \< 25% before first Zevalin infusion.
9. Neutrophils count ³ 1.5 x 109/l, Haemoglobin ³ 9 g/dl, Platelets ³ 100 x 109/l before second Zevalin infusion
10. Use of effective contraception for the entire treatment period in patients sexually active
11. Negative pregnancy test in child bearing potential women
12. Life expectancy \> 6 months
13. Written informed consent

Exclusion Criteria:

1. More than two lines of prior chemotherapy before study entry
2. Prior high dose chemotherapy and autologous stem cell transplantation
3. HIV positivity
4. HBV positivity with the exception of patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative
5. HCV positivity with the exception of patients with no signs of active chronic hepatitis histologically confirmed
6. History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
7. Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug
8. Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 5, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
9. Pregnant or breastfeeding
10. CNS lymphoma involvement.
11. History of malignant carcinoma within the last 3 years other than squamous cell and basal cell carcinoma.
12. Cardiac failure with VEF \< 40%
13. Clinical evidence of not controlled infections
Comparison of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 12 months
* Treated with oral antidiabetic drugs or with any insulin regimen with or without oral antidiabetic drugs
* BMI of maximum 40 kg/m2
* HbA1c greater than or equal to 7.0% and less than or equal to 11.0%

Exclusion Criteria:

* Proliferative retinopathy or maculopathy
* Recurrent major hypoglycaemia
* Impaired hepatic or renal function
* Cardiac problems or uncontrolled hypertension
Quantitative Assessment of Lid Margin Vascularity Using SS-OCTA

To explore an optimized scan technique for the detection of lid margin vasculature

To investigate whether the SS-OCTA tool has the potential to characterize the lid margin vascularity in MGD patients. The repeatability and validity of OCTA in assessing eyelid margin blood flow density was evaluated。

Eligibility Criteria:
Inclusion Criteria:

The MGD patients were aged \>_20 years and were diagnosed according to Chinese MGD diagnostic criteria,11 including dry eye symptoms, and at least one of the following signs: (1) poor meibum expressibility or quality; (2) at least one of eyelid margin abnormalities (lid margin irregularity, plugging of the gland orifice, vascular engorgement/telangiectasia, and anterior replacement of the mucocutaneous junction. Normal subjects were defined as adults without any dry eye symptoms and lid margin abnormality.

Exclusion Criteria:

(1) subjects with ocular diseases or conditions known to affect the anatomy of the anterior segment, such as acute ocular inflammation, a history of eyelid surgery, contact lens wear within two weeks, and/or eyelid trauma; (2) subjects with of history of systemic or topical medications that might cause ocular congestion; (3) subjects with severe systemic illness or pregnancy; and (4) subjects who were difficult to cooperate with examination, resulting the obtained images were not sufficiently clear for automatic analysis.
Lifestyles, Arterial Aging and Intestinal Microbiota (MIVAS III Study)

This is an observational cross-sectional study whose objective is to analyse associations between the intestinal and salivate microbiota with lifestyles (eating patterns, physical activity, tobacco and alcohol consumption), arterial aging and cognitive function. It will take place in five different research units located in Spain

Aim: To analyze the association of lifestyles (eating patterns, physical activity, tobacco and alcohol consumption) with the intestinal and salivate microbiota and its relationship with arterial aging and cognitive function in subjects without cardiovascular disease in Spain and Portugal. In addition, the mediating role of the intestinal microbiota in the relationship of lifestyles with arterial aging and cognitive function will be analyzed.

Design: A cross-sectional study with a case-control analysis, to analyze the association of microbiota patterns with arterial ageing. Setting: the study will develop the research network in health prevention and promotion (Rediapp) and in the Iberian network on arterial structure and the Cancer Research Center of Salamanca. Study population: 1000 subjects aged 45 to 74 years without cardiovascular disease, will be selected.

Variables: Demographic, anthropometric and habits (tobacco and alcohol). A dietary pattern through a frequency consumption questionnaire (FFQ), the software of the EVIDENT III and the Mediterranean Diet adherence questionnaire. Physical activity: International Physical Activity Questionnaire (IPAQ), Marshall Questionnaire and Accelerometer, Actigraph. Body composition (Inbody 230 impedance meter). Arterial aging: Medium intimate carotid thickness (Sonosite Micromax); Analysis (PWA) and pulse wave velocity (cf-PWV), (Sphygmocor System). Cardio Ankle Vascular Index (CAVI), ba-PWV and ankle-brachial index (Vasera VS-2000®). With Ambulatory Pulse Wave Analysis (Microsoft®), the PAIx and CAIx and the heart rate variability will be measured. The vascular damage in the retina, heart, kidney, brain and cardiovascular risk will be measured. Intestinal microbiota with the OMNIgene GUT kit (OMR -200) and analysis of the 16S rRNA microbiome profile by massive sequentiation. (Lifestyles, arterial aging, neurocognition, microbiota)

Eligibility Criteria:
Inclusion Criteria:

* People aged 45 to74 years who agree to participate in the study and who not meet any of the exclusion criteria

Exclusion Criteria:

* Participants with a personal history of cardiovascular disease (ischaemic heart disease or stroke, peripheral arterial disease or Heart Failure)
* Participants with a BMI\> 40 kg / m2
* Participants diagnosed renal failure in terminal stages (GFR \<30 ml / min);
* Chronic intestinal inflammatory disease or acute inflammatory process in the past 3 months
* Oncology disease diagnosed in the last 5 years or with active treatment
* Participants who are in a terminal condition
* Consumption of antibiotics last 15 days
Prevention of Overweight in Infancy

Obesity is one of the biggest threats to health in the 21st century. Rapid weight gain in the first year of life tends to lead to overweight in children, which in turn leads to overweight in adults. This rapid early weight gain occurs most often at weaning when eating patterns emerge. Infant sleep problems also appear to be associated with the risk of becoming overweight, and contribute to maternal post-natal depression. We propose to undertake a 4-arm randomised controlled trial to determine whether extra education and support for families around weaning and development of early food and activity habits, with or without intervention to improve infant sleep, will decrease the current risk patterns of rapid excessive early childhood weight gain in New Zealand. This would provide strong evidence for the value of such a strategy in the long term control of the obesity epidemic and its consequent complications.

This is a two-year intervention with follow-ups at 3.5, 5 and 11 years of age.

We plan on undertaking a 4-arm randomised controlled trial to test the following hypotheses:

1. That anticipatory guidance and extra education and support in infancy around weaning and decreasing/avoiding television watching will delay the timing of introduction of solid foods, will be associated with more successful introduction of nutrient dense foods with appropriate portion size and decrease small screen exposure leading to a lower number of children with excessive weight velocity in infancy and early childhood.
2. That anticipatory guidance, education and extra support around the early development of infant sleeping patterns will decrease sleep problems, increase infant sleeping time, decrease arousals at night and lower sleep latency which will in turn influence rate of early infant weight gain.
3. That interventions 1 and 2 will interact additively with regard to infant and early childhood weight gain.
4. That intervention 2 will lead to lower rates of maternal depression and increased family well being.

Eligibility Criteria:
Inclusion Criteria:

* Mothers booked for delivery in Dunedin, New Zealand

Exclusion Criteria:

* Women booked after 34 weeks gestation,
* Identified congenital abnormality likely to affect feeding and/or growth
* Home address outside of metropolitan Dunedin or Invercargill,
* Families who are likely to shift out of metropolitan Dunedin or Invercargill in the next 2 years.
* Unable to communicate in English or te reo Maori.
Study of Fluid Collection of the Chest in Children With Pneumonia

The purpose of this study is to determine the best treatment for children with a fluid collection in the chest associated with an underlying pneumonia. Researchers generally agree that a child with a large fluid collection in the chest need to have the fluid drained in addition to anitbiotics. There have been many treatments studied in children that have been shown to be effective and safe, but the treatments have never been compared to each other in a randomized controlled study.

The optimal treatment of pediatric parapneumonic effusions remains controversial. The objective of this study is to compare the use of conventional management (antibiotics with thoracostomy tube placement) with primary thorascopic drainage (see protocol). Our hypothesis is that pediatric patients with parapneumonic effusion, regardless of pleural fluid composition and loculations, have decreased morbidity when treated with early thoroscopic adhesiolysis (VATS) compared with conservative treatment.

The ultimate objective of this study is to rationalize treatment decisions. It is our hope that this pilot study will provide the basis for further randomized prospective studies. The expected benefit is that the current treatment and outcome of pediatric parapneumonic effusions will be determined. Insights into the therapy that results in the least morbidity, hospital days, (and therefore cost) will be elucidated. If our hypothesis is valid, then a more aggressive surgical approach to the treatment of a parapneumonic effusion may be warranted. If the hypothesis is not valid, then the appropriate treatment for a parapneumonic effusion, irrespective of institution and personal opinion, should become more apparent.

Eligibility Criteria:
Inclusion Criteria:

1. consecutive pediatric patients with a bacterial pneumonia and parapneumonic effusion
2. community acquired disease
3. children age 0 to 18 years

Exclusion Criteria:

1. hospital acquired pneumonia
2. thoracentesis or chest tube drainage outside hospital
3. patients with incorrected cardiac disease
Evaluation of the Dynamic Work Intervention for Office Workers to Reduce Sedentary Behaviour

Long-term sitting has been associated with multiple health risks. To reduce sitting time for office workers in a Dutch insurance company, an intervention will be implemented. The goal of this study is to evaluate this intervention on the short term (3 months) and long-term (12 months).

Large volumes of sitting time have been associated with multiple health risks such as diabetes, heart disease and premature death. Especially, in office workers sitting time per day can accumulate to over 10 hours a day. To reduce sitting time for office workers in a Dutch insurance company, an intervention will be implemented. The intervention contains the introduction of alternative workstations, intervention sessions with an occupational physiotherapist and an activity tracker with a self-help program booklet. The goal of this study is to evaluate the (cost) effectiveness of this intervention on the short term (3 months) and long-term (12 months). The primary outcome is objectively assessed sitting time.

In a cluster randomized controlled trial 250 employees of an insurance company will participate in the study. After baseline measurements, matched departments will be randomly assigned to the control or intervention group. The evaluation includes an economic and process evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Employed by the insurance company for at least the duration of the study (12 months)
* Employed at least 28 hours per week
* Employed at one of the participating departments

Exclusion Criteria:

* Already access to the Dynamic Working Intervention
* Unable to stand or walk for longer time periods (i.e. wheelchair bound)
* Pregnancy
A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)

This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F).


Eligibility Criteria:
Key Inclusion Criteria:

* Homozygous for the F508del mutation (F/F)
* Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for age, sex, and height

Key Exclusion Criteria:

* Clinically significant cirrhosis with or without portal hypertension
* Lung infection with organisms associated with a more rapid decline in pulmonary status
* Solid organ or hematological transplantation

Other protocol defined Inclusion/Exclusion criteria may apply
Advanced Hybrid Closed Loop System (AHCL) in Older Patients With Type 1 Diabetes Mellitus

The trial is a randomized controlled, parallel group design study. Patients will be followed up during approximatively 12 months.

Patients will be randomized to either the MDI/CSII group which will continue their treatment as per routine procedures and the advanced Hybrid Closed Loop system (AHCL) group which will be connected to the Minimed 780G system. .

At the end of the 12 month study period, we will evaluate whether the AHCL system improved glucose indices in older individuals with Type 1 diabetes mellitus (T1DM) and assess whether the ACHL treatment improved physical capacity, frailty \& sarcopenia indices as well as quality of life and cognitive functions.

All participants will go through a screening phase that includes an eligibility assessment, informed consent forms, Cognitive function assessment ( QoL questionnaire, WHO-5 questionnaire, MOCA, DSST, General Heath question), Sarcopenia/functional status/frailty assessment ( Timed up and Go , 6 min walk, 10 meter walk, Berg Balance Scale , Four Square Step Test , Grip Strength, 30 second chair stand, Fried Scale) and Lab tests.

After the screening, the participants will start a two week run in phase while continuing their routine procedures with an added unblinded G4 guardian standalone sensor.

sensor and data will be collected for 14 days and afterwards patients will be randomized to either the MDI/CSII group which will continue their treatment as per routine procedures and the AHCL group which will be connected to the Minimed 780G system. Both groups will have a similar number of visits in order to minimize bias. However, the AHCL group will have 2 additional visits to allow for patients to be trained on the AHCL system. After 6 months, both groups will be connected to the standalone sensor and glucose data will be collected after 2 weeks.

After 12 months of the study period, all participants will undergo primary assessments, blood tests questionnaires and will finish their part in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Age over 60 years
2. T1DM
3. Willing to participate in a study for the specified duration
4. Willing to perform ≥ 4 finger stick blood glucose measurements daily or connected to a "basket approved" CGM
5. Willing to wear the system continuously throughout the study
6. Treated with MDI/CSII (with exclusion of 780G or other hybrid closed systems)
7. Lack of advanced complications of diabetes

Exclusion Criteria:

1. Severe concurrent illness
2. Laboratory abnormalities, or medications that might affect study participation,
3. Severe renal impairment
4. Any illness that may interfere with study procedures
Safety and Performance Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts

The purpose of this research is to collect data on patients that had the Legion CR Oxinium and CoCr Femoral Implant and the Legion/Genesis II XLPE High Flex Tibial Inserts implanted in the past. Smith \& Nephew will evaluate the safety and performance of these implants.


Eligibility Criteria:
Inclusion Criteria:

1. Subject received primary TKA with the Legion™ CR Femoral Implant (either Oxinium or CoCr) with Legion™/Genesis™ II XLPE Hi-flex Tibial Insert, due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, degenerative arthritis, or rheumatoid arthritis).
2. Subject received primary TKA between 24 and 66 months prior to the time of consent.
3. Subject agrees to consent and to follow the study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/EC approved informed consent form.
4. Subject must be available through ten (10) years postoperative follow-up.

Exclusion Criteria:

1. Subject had Body Mass Index (BMI) \> 40 at time of surgery.
2. Subject received the Legion™ CR Femoral Implant with Legion™/Genesis™ II XLPE Hi-flex Tibial Insert as a revision surgery.
3. Subject has a condition that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).
4. Subject has a known allergy to one or more of its components of the study device.
5. Subject, in the opinion of the Principal Investigator (PI), has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
6. Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days.
7. Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.