cyrilzakka/clinical-trials huggingface dataset:
An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)

This is a Phase 3, open-label, extension study to assess the long term efficacy and safety of lirentelimab given monthly.


Eligibility Criteria:
Key Inclusion Criteria:

1. Provide written informed consent.
2. Completed Study AK002-016, defined as having received 6 infusions of study drug and followed through Day 176 (±3) or completed Study AK002-012, defined as having received the cohort-appropriate amount of doses and followed for 5 months after last dose of study drug.
3. If patient is on pre-existing dietary restrictions, willingness to maintain those restrictions, throughout the study.
4. Able and willing to comply with all study procedures.
5. Female patients must be either post-menopausal for at least 1 year or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity until the end of the study, or for 120 days following the last dose of study drug, whichever is longer.
6. Male patients with female partners of childbearing potential must agree to use a highly effective method of contraception until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant at any time during study participation.

Key Exclusion Criteria:

1. Known hypersensitivity to any constituent of the study drug.
2. Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the patient at increased risk.
3. Planned or expected vaccination with live attenuated vaccines during the Treatment Period, or vaccination expected within 5 half-lives (4 months) of AK002 administration.
4. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
5. Any other reason that, in the opinion of the Investigator or Medical Monitor, makes the patient unsuitable for enrollment.
Dietary Diversity of Young Children During CoVID-19 Outbreak: A Longitudinal Study

The 2019-2020 coronavirus pandemic has had far-reaching consequences beyond the spread of the disease. Quarantine measures during a public health pandemic can be particularly detrimental to urban poor families and affect the dietary diversity and food security. This can disproportionately affect young children aged 6 and below, and severely impact those \<2 years. Sudden unemployment may result in an unexpected reduction in income that will place pressure on daily budgets for food. Children of families may not have access to foods of adequate diversity that will enable them to meet their macro and micronutrient requirements for growth and development, especially during the Movement Control Order (MCO). The study plans to monitor and evaluate dietary diversity in young children's food intake after the MCO and use the collected information to direct targeted food aid to address observed macro- and micronutrient deficiencies among the urban vulnerable group.

Children are the future to our society. The first thousand days of life, starting from conception till one's second birthday is a critical period of cognitive and physical development. It is the most sensitive period where brain development is most receptive to positive nutrition. Any form of malnutrition, especially during this golden time frame, can lead to irreversible effects to growth, health, education and future career attainment to our potential leaders, which in turn can be a barrier to human development.

The CoVID outbreak is a unique period in recent human history where drastic public health measures such as MCO for an extended period of time has to be implemented nation-wide. These measures have untold severe consequences on the food security of the vulnerable urban group, in particular the young children whose brains require diverse micronutrients to support the rapid growth. These micronutrients can only be obtained from a daily diet that is equally diverse, especially from fresh vegetables and fruits which will be short in supplies. These perishable food items are not usually included in food aids, thus the child may have to subsist on staple-rich diet which are energy-dense but nutrient-poor. These dietary practices are associated with negative health outcomes. Thus by monitoring dietary diversity of the children, we hope to better inform food aid organisations to consider the inclusion of healthier food options to prevent micronutrient deficiencies.

Eligibility Criteria:
Inclusion Criteria:

* All well-children aged between 6 months and 6 years

Exclusion Criteria:

* Children with chronic illnesses
A Study of AK109 and AK104 in Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

This is a multicentre, Phase Ib/II Clinical Study of AK109 and AK104 With or Without Chemotherapy in Second-line Treatment of Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma .


Eligibility Criteria:
Inclusion Criteria:

1. Written and signed informed consent
2. Age ≥ 18 years but ≤ 75 years
3. ECOG of 0 or 1.
4. Estimated life expectancy of ≥3 months.
5. Histologically or cytologically documented advanced unresectable or metastatic gastric adenocarcinoma or gastroesophageal Junction (GEJ) adenocarcinoma.
6. At least one measurable lesion per RECIST v1.1.
7. Gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma with failure of first-line treatment with anti-PD-1/L1 and chemotherapy
8. Adequate organ function.
9. Have agreed to take effective contraception from the date of signing the informed consent form until 120 days after the last administration.

Exclusion Criteria:

1. Other invasive malignancies within 3 years, except for locally treatable (manifested as cured) malignancies, such as basal or skin squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ.
2. Any previous systemic therapy targeting VEGF or anti-VEGFR signaling pathways.
3. In addition to PD1 or PD-L1,Prior exposure to anti-CTLA-4 antibody, or any other antibody or drug therapy for T cell co-stimulatory or checkpoint pathways, such as ICOS or agonists (e.g. CD40, CD137, GITR and OX40 etc).
4. Known history of primary immunodeficiency virus infection.
5. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
6. Known history of interstitial lung disease.
7. Known history of active tuberculosis (TB).
8. Central nervous system (CNS) metastasis, meningeal metastasis, spinal cord compression, or leptomeningeal disease.
9. Patients with untreated chronic hepatitis B or HBV DNA exceeding 500IU/mL or active hepatitis C should be excluded. Patients with HCV antibody positive are eligible to participate in the study if the results of HCV RNA test show negative.
10. Known history of testing positive for human immunodeficiency virus (HIV).
11. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
12. Subjects with active, known or suspected autoimmune disease, or a medical history of autoimmune disease, with the exceptions of the following: vitiligo, alopecia, Grave disease, psoriasis or eczema not requiring systemic treatment within the last 2 years, hypothyroidism (caused by autoimmune thyroiditis) only requiring steady doses of hormone replacement therapy and type I diabetes only requiring steady doses of insulin replacement therapy, or completely relieved childhood asthma that requires no intervention in adulthood, or primary diseases that will not relapse unless triggered by external factors.
13. Pregnant or lactating women.
Opioid Free Anesthesia in Breast Cancer Surgery

A comparison of incidences of postoperative nausea and vomiting (PONV) , postoperative pain severity and recovery parameters in breast cancer patients receiving opioid or opioid-free general anesthesia.

Breast cancer is one of the most common oncologic diagnosis in women. Surgery is traditionally performed under general anesthesia with opioid-based analgesia. It is associated with higher incidences of PONV, more severe acute postoperative pain and increased incidences of chronic pain. The possibility of higher risk of metastasis has also been reported.

The purpose of our study is to compare the opioid-free general anesthesia with the opioid-based general anesthesia with respect to the quality of recovery, postoperative pain and cancer recurrence and metastasis.

Eligibility Criteria:
Inclusion Criteria:

1. first diagnosis of histologically confirmed primary breast cancer without known extension beyond the breast and axillary nodes;
2. ASA physical statue I-II;

Exclusion Criteria:

1. chronic pain and opioid administration history;
2. allergy to local anesthetics or NSAIDs;
3. coagulation disorders;
4. local infection at regional block site;
5. unable to comply to study protocol schedule for logistic or other reasons;
6. refusal to participate to the study；
7. breast reconstruction with implants or latissimus dorsi flap
Plantar Sensation, Balance, Risk of Falling and Gait in Patients With Schizophrenia

Cerebellar vermis anomalies are present in schizophrenic individuals. This condition leads to postural balance problems. Foot and ankle complex have a special role for maintaining balance. However, there is no study about this topic in schizophrenic individuals.


Eligibility Criteria:
Inclusion Criteria:

* diagnose of schizophrenia according to DSM-5
* being an individual in remission against the risk of having an attack
* individuals who use the same psychotropic drugs for at least 4 weeks

Exclusion Criteria:

* Individuals with physical and neurological comorbidities
Electro-acupuncture and Flumazenil's Effect on Sedation

Object: To explore the mechanism of the electro-acupuncture (EA) induced sedation effect in general anaesthesia through investigating the role of the Benzodiazepines-GABA system.

Method: 80 patients undergoing abdominal surgery were randomly divided into four groups (n=20): C group (propofol only group), F group (propofol + flumazenil group), EA group (propofol + electro-acupuncture group), and EA+F group (propofol + electro-acupuncture + flumazenil group). Before induction, acupuncture needles were inserted at the points of Zusanli (ST 36) and Neiguan (PC 6) bilaterally to elicit"DeQi". Target-controlled infusion (TCI) of propofol was used for the induction and maintenance of anaesthesia. After 15minutes, equilibrium of Narcotrend Index (NT index) was achieved, patients were then assigned to receive different interventions. In EA group and EA+F group, patients received EA for 30 minutes under general anaesthesia, and flumazenil with the dosage of 0.1mg/kg was added in the latter at the end of EA. In C group and F group, patients didn't receive EA, and flumazenil with the dosage of 0.1mg/kg was administered in F Group at the same time point with EA+F group. HR, MAP and NT index were recorded at different time points up to 30 minutes after the end of EA.


Eligibility Criteria:
Inclusion Criteria:

* 80 abdominal surgical patients
* aged 30 to 60 years old,
* weighing 50-70Kg,
* ASA I-Ⅱ, who scheduled to receive general anaesthesia were enrolled to this trial.

Exclusion Criteria:

* Hypertension or severe heart and lung diseases,
* Conditions that might affect the consciousness or NT index, such as seizures, psychosis, brain lesions, and treatment with sedative drugs,
* Contraindications to acupuncture, such as severe hemorrhagic disease, hyper-sensitive patient, and tumor or ulcer exist on the skin of the acupuncture points.
Regeneration of Posterior Cruciate Ligament Injury Using Hypoxic Conditioned Allogenic Adipose Mesenchymal Stem Cell and Condition Medium

Transplantation of Allogenic Adipose Mesenchimal Stem cell in hypoxic cultur condition with Ligament- derived conitioned medium can enhance regeneration of posterior cruciate ligament rupture

this study is in vivo study to prove effect of transplantation of Allogenic Adipose Mesenchimal Stem cell in hypoxic cultur condition with Ligament- derived conitioned medium in regeneration of posterior cruciate ligament rupture

Eligibility Criteria:
Inclusion Criteria:

* white male new zealand rabbit
* weight 2500 - 3000 gram

Exclusion Criteria:

* have no disease
Optical Coherence Tomography Angiography (OCT-A) in Children (≥ 6 <14 Years of Age)

Comparison of OCTA to conventional imaging modalities for the diagnosis of eye diseases in children

Optical coherence tomography angiography (OCTA) is a new non-invasive imaging technique that employs motion contrast imaging to high-resolution volumetric blood flow information. OCTA compares the decorrelation signal between sequential OCT b-scans taken at precisely the same cross-section in order to construct a map of blood flow. At present, level 1 evidence of the technology's clinical applications doesn't exist. The investigators plan to compare OCTA as an imaging modality to conventional imaging modalities used in clinical routine.

Eligibility Criteria:
Inclusion Criteria:

* Patients (children ≥ 6 \<14 years of age) from the Childrens Hospital, University Hospital Bern requiring routine internal medical check-up for the diagnosis of diabetes or children attending routine eye exams at the department of ophthalmology, who are willing to participate in the study, and whos parents are willing to sign informed consent on behalf of their child.
* Patients need to be at least 6 years of age (but younger than 14 years) 6 years of age or younger

Exclusion Criteria:

* Patients (children) who are not willing or able to participate, or potential participant's parents who are not willing to sign informed consent on behalf of their child.
* Patients younger than 6 years of age or 14 years or older.
* Patients (children) with epilepsy
Study to Evaluate Efficacy and Safety of Imiglucerase Treatment in Chinese Patients With Gaucher Disease Type Ⅲ

Primary Objective

* To evaluate the efficacy on hematologic manifestations of imiglucerase treatment in Chinese patients who are diagnosed as Gaucher disease type Ⅲ
* To evaluate the safety profile of imiglucerase in maximum dose in the label (60U/kg, IV biweekly) in Chinese patients.

Secondary Objective

* To evaluate the efficacy on viscera manifestations of imiglucerase treatment in Chinese patients who are diagnosed as Gaucher disease type Ⅲ
* To evaluate the efficacy on bone disease of imiglucerase treatment in Chinese patients who are diagnosed as Gaucher disease type Ⅲ
* To evaluate the effect on quality of life of imiglucerase treatment in Chinese patients who are diagnosed as Gaucher disease type Ⅲ

Approximatively 14 months including a 12 months treatment period

Eligibility Criteria:
Inclusion criteria:

* Capable of giving signed informed consent.
* Participant is diagnosed with GD type Ⅲ
* Participant with neurological manifestations
* Participant whose age is \> 2 years old.
* Participant whose spleen and/or liver volume is \> ULN at Screening.

Exclusion criteria:

* Major congenital anomaly
* Clinically significant intercurrent organic disease unrelated to Gaucher disease, which means the disease or condition that may have impact on the parameters chosen for primary endpoints (e.g. level of hemoglobin platelets, liver/spleen enlargement and bone pains)
* Prior treatment with ERT.
* Physical conditions that cannot tolerate regular treatment or follow-up visit.
* Pregnant or lactating women
* Participant is participating in or has participated in another clinical study using any investigational therapy in 3 months
* Participant has been diagnosed with central nervous system disease unrelated to Gaucher disease, or MRI result of the participant indicates space-occupying lesion in central nervous system
* The patient has a documented hemoglobinopathies, deficiency of iron, vitamin B-12, or folate that requires treatment not yet initiated or, if initiated, the patient has not been stable under treatment for at least 6 months prior to administration of the first dose of Cerezyme in this study
* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
* Any specific situation during study implementation/course that may rise ethics considerations
* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Myocardial Hemodynamic Effects of Levosimendan

This study will test the hypothesis that mechanical efficiency as measured by pressure-volume loop assessment should improve during short-term treatment with intravenous levosimendan.

Levosimendan (SimdaxTM, Abbott Laboratories, Abbott Park, IL) is a calcium sensitizer which has been shown to have beneficial hemodynamic effects in patients with decompensated congestive heart failure (CHF). Levosimendan is a new calcium sensitizer that binds to troponin C. This agent is approved in Europe for treatment of heart failure patients. In the United States, this agent is currently under phase III investigation for intravenous treatment of patients with acutely decompensated HF who have dyspnea at rest or with minimal activity. Levosimendan has been studied in these patients with acute HF and is considered experimental in the United States for this population.


Eligibility Criteria:
Inclusion Criteria:

* All patients will have either a sinus or paced atrial rhythm with atrioventricular synchrony on electrocardiography
* All patients will have a history of heart failure diagnosed clinically with history of prior symptoms or signs of heart failure with at least one of the following symptoms within the past month: dyspnea on exertion, orthopnea, paroxysmal nocturnal dyspnea, pedal edema
* In asymptomatic patients, patients may be enrolled if they have at least one of the following clinical signs of heart failure: left ventricular third and/or fourth heart sound, jugular venous pressure \>7 mmHg, sustained left ventricular impulse, or pulmonary congestion on auscultation
* all patients will have echocardiographic evidence of left ventricular dysfunction

Exclusion Criteria:

* Under age 18
Management and Outcome of Mesh Infection After Abdominoplasty in a Tertiary Care Centre

Hernia repair is among most frequent surgical interventions. The use of abdominal mesh in hernia repair has become the Gold Standard strategy, reducing the risk of relapse.

The mesh infection risk is estimated lower than 1% in simple situations, but can increase up to 20% in complicated patients. Risk factors are well known, but we lack data regarding the therapeutic strategies and outcomes.

This study aims to describe the characteristics and management of abdominal mesh infections, and the related outcomes.


Eligibility Criteria:
Inclusion Criteria:

* parietal mesh infection
* age \> 18

Exclusion Criteria:

* Non French speaking patients.
* Persons under tutorship or curatorship.
Feasibility Study of a Virtual Reality Cognitive-motor Task Based on Positive Stimuli for Stroke Rehabilitation

The purpose of this study is to determine whether it is feasible to use a virtual reality task for stroke rehabilitation for training motor and cognitive (attention and memory) domains based on the use of positive stimuli, and to evaluate the potential benefits in comparison to standard rehabilitation.

There is evidence that positive emotion stimuli can lead to improved performance in attention tasks and the investigators aim to understand the benefits of using this principle in cognitive and upper-limb motor rehabilitation following stroke. For this purpose, the investigators developed a VR attention task in which the user has to find a target image within a variable number of distractors by controlling a virtual arm. In some levels of the task the target has to be memorized, hence training both attention and memory. The target stimuli are positive images based on the individual preferences of each user.

40 participants within the first 6 months after stroke will be randomly allocated to one of two groups: 1) VR motor-cognitive task or 2) standard rehabilitation. The VR motor-cognitive task group will use the above described virtual task customized to each user in terms of the positive content. This also includes selected music that will be introduced in half of the sessions. The standard rehabilitation group will undergo conventional motor and cognitive rehabilitation. The intervention consists of 12 sessions of 45 minutes administered within a 4-6 weeks period. The participants will be evaluated using a number motor and cognitive assessment scales at baseline, end of the intervention and a 1-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* ischemic or hemorrhagic stroke within the first 6 months post-stroke
* motor impairment of the upper extremity but with a minimum score of 28 in the Motricity Index (elbow flexion and shoulder abduction domains combined score)
* cognitive deficit but with enough capacity to understand the task and follow instructions with a minimum score of 11 over 17 in the Token Test (6-item version, portuguese population)
* able to read

Exclusion Criteria:

* previous motor and/or cognitive deficits
* normal cognitive functioning with a score above 26 points in the Montreal Cognitive Assessment
* unilateral spatial neglect
* moderate to severe depressive symptomatology with a score above 20 points in the Geriatric Depression Scale
* vision disorders that may interfere with the execution of the task