cyrilzakka/clinical-trials huggingface dataset:
Early Diagnosis of Upper Digestive Tract Disease

Upper digestive tract cancer (UDC) is a major disease burden worldwide encompassing all cancers involving the digestive tract (from oral cavity to duodenum). A majority of patients presenting with this disease are diagnosed late and have poor overall survival rates (\<20%). NICE referral guidelines for diagnostic endoscopy are usually associated with late disease. Exhaled breath testing is a non-invasive and acceptable technology utilising mass spectrometry (MS) which has shown promise at diagnosing cancer at an early stage.

Previous research has shown that products formed as a result of metabolism can be measured in breath and saliva (biomarkers). This has the ability to accurately identify patients with upper gastrointestinal (UGI) cancers from breath. Our initial pilot data has demonstrated that changes in the breakdown of metabolites release volatile organic compounds (VOC) which can be measured with MS. This data is supported by other patient studies. However no previous study has been performed utilising a non-invasive technique with breath and saliva. Thus the aim of this study is to identify VOCs present in patients with this disease.

In this multi-centre study the investigators want to overcome the limitations of previous work by utilising non-invasive samples (breath, saliva and urine) in patients in multiple sites. The investigators aim to conduct a study in patients with UDC and those without. The investigators hope that the results of this study will provide evidence for large scale analysis of patients with this disease, demonstrate the feasibility of this technique and move this valuable test forward into mainstream medical practice. The major advantage of this test is that it is easy to undertake and painless for the patient. This study of products in breath, saliva and urine will be useful for detecting UDC to allow treatment at an early stage, improving overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Any patient who:

  * is ≥ 18 years old and below 90 years of age, AND:
  * is undergoing endoscopy as part of their routine clinical care, OR:
  * is undergoing surgical resection of orodigestive tract disease as part of their routine clinical care, OR:
  * is undergoing treatment of orodigestive tract disease as part of their routine clinical care

Exclusion Criteria:

* Any patient who:

  * Lacks capacity or is unable to provide informed consent.
  * Any patient below 18 years of age or over 90 years of age.
Enhanced Algorithm for Crohn's Treatment Incorporating Early Combination Therapy

Assess if the implementation of an enhanced treatment algorithm will improve the management Crohn's Disease compared to a conventional Step-care approach.

Crohn's disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract. During disease exacerbations, pharmacological or surgical intervention is usually needed to re-establish remission. Ideally, strategies should be employed to maintain patients in long-term remission while minimizing exposure to corticosteroids and reduce therapy-related toxicity.

Nevertheless, in reality many patients with CD do not receive effective therapy and their disease often remains active, leading to uncontrolled inflammation and complications from either the underlying disease or corticosteroids.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of CD
* Written informed consent must be obtained and documented.
* Willing to utilize study supply of adalimumab provided in syringe format, if indicated according to treatment algorithm.

Exclusion Criteria:

* Any conditions (e.g., history of alcohol or substance abuse) which, in the opinion of the investigator, may interfere with the patient's ability to comply with study procedures.
* Latex allergy or other conditions in which adalimumab syringes are contraindicated
* Currently participating, or planning to participate in a study involving investigational product within 24 months that may interfere with the patient's ability to comply with study procedures.
* Previously failed all classes of tumor necrosis factor (TNF) antagonists for the treatment of CD.
* Diagnosis of short bowel syndrome
A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis

The purpose of this study is to see how safe and effective Lacosamide (LCM) is when taken by mouth, twice a day for up to 18 weeks to prevent migraines.

This study is for subjects who have been diagnosed with migraine for at least one year and who are currently taking an effective abortive medication(s).

Eligibility Criteria:
Inclusion Criteria:

* History of migraines headaches for 1 year and well documented 3 month retrospective history of migraines.
* Experience 2-8 migraines per month but not more than 15 headache days per month. There should be at least 48 hours of freedom between headaches.
* On effective stable abortive medication(s) for the acute treatment of migraine.

Exclusion Criteria:

* Subject in another investigational drug or device study within the last 30 days or is currently in another investigational drug trial.
* Use of triptans or ergots for migraine abortive treatment \> 2-3 days per calendar week 2 months prior to screening.
* Experience 15 or more headache days per month of any kind 2 months prior to screening.
* Has another consistent or chronic form of headache.
* Unable to stop medications, herbs, vitamins, or minerals used to prevent a migraine from occurring.
* Pregnant or nursing women and those of child bearing potential who are not surgically sterile, or 2 years post menopausal, or do not practice 2 combined methods of birth control, unless sexually abstinent, during the trial.
* Significant laboratory or electrocardiograms (ECG) abnormalities
* Significant medical history including cardiovascular abnormalities.
Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020

A Six-Week, Randomized, Double-Blind, Parallel Group Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 Compared To Risperidone, In Schizophrenic Patients Previously Treated In Study Bl-1020 Iib For A Maximum Of Six Weeks With Bl-1020 (High Dose, Low Dose), Risperidone Or Placebo

This is a six-week, randomized, double blind, multi-center, parallel group Extension to the BL-1020 IIb study. In this Extension Study in patients hospitalized with schizophrenia who were previously treated in the BL-1020 IIb study with BL-1020 (low dose: 10 mg/day; high dose: target dose 30 mg/day), risperidone (target dose: 8 mg/day) or placebo after experiencing an acute exacerbation of schizophrenia. Patients who completed the 6 week treatment period and/or all efficacy assessments in Study BL-1020 IIb are eligible to continue double-blind treatment in this optional 6 week Extension Study. Approximately 220 patients will be enrolled in this study: Treatment Group IE (n=82, 10 mg/day BL-1020); Treatment Group IIE (n=82: target dose 30 mg/day BL-1020); Treatment Group IIIE (n=55; target dose 8 mg/day risperidone). Study drug (BL-1020 or risperidone) will be administered orally, once daily, in a doubleblinded manner, during this six-week Extension Study

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18-65 years of age at the time of entry into the BL-1020 IIb study
2. Has provided informed consent to participate in the Extension Study
3. Has completed 6 weeks of treatment and/or completed all efficacy assessments in Study BL-1020 IIb
4. Females must have negative serum pregnancy test, or be post-menopausal, or if fecund, must practice established methods of birth control (oral contraceptive tablets, hormonal implant device, hormone patch, injectable contraceptive, intrauterine device \[IUD\]) for at least two months prior to screening
5. Females must use an established method of birth control (as above) AND a barrier method (condom, diaphragm, contraceptive foam) while taking study medication
6. Has a caregiver or an identified responsible person (e.g., family member, social worker, nurse) who will support him/her to ensure compliance with the treatment and outpatient visits
7. Is willing to comply with not taking any prohibited medications during participation in the study
8. Successful completion of End of Study assessments from BL-1020 IIb

Exclusion Criteria:

1. Is unwilling or unable to provide informed consent
2. Is unwilling or unable, in the opinion of the Investigator, to comply with study instructions
3. Has a medical condition that would put him/her at risk for continuing in the study
4. Score \> 9 on Modified InterSePT Scale for Suicidal Thinking (Modified ISST)
5. Tested positive for drugs of abuse during the initial 6 weeks of treatment (Study BL-1020 IIb)
6. Has been non-compliant with the study medication dosing and/or study procedures during the initial 6 weeks of treatment in Study BL-1020 IIb
7. Is judged by the PI to be inappropriate for the study
ESPB Versus INB With PCIA in Video-assisted Thoracic Surgery

A randomized prospective trial to test the non-inferiority of erector spinae plane block (ESPB) in comparison with intercostal nerve block combined with patient-controlled intravenous analgesia in Thoracoscopic lung surgery

For patients undergoing thoracic surgery, postoperative pain greatly limited their recovery.Multimodal analgesia have shown good efficacy but without reaching full pain relief.

The primary goal of this study is to observe the effect of ultrasound-guided erector spinae plane block in comparison with intercostal nerve block combined with patient-controlled intravenous analgesia in video assisted thoracic lung surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients to receive video assisted thoracoscopic lobectomy or bullectomy .

Exclusion Criteria:

* 1. Patient refusal 2. Heavy skin eruption and infection at site of injection. 3. Coagulopathy. 4. Allergy to local anesthetics. 5. Taking analgesics.
Classroom Study to Assess Efficacy and Safety of MTS in Pediatric Patients Aged 6-12 With ADHD

Evaluate the behavioral effects of MTS in children aged 6-12 with ADHD

Evaluate the behavioral effects measured by the SKAMP deportment scale of MTS compared to placebo in children aged 6-12 with ADHD

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis ADHD
* Total score of greater than or equal to 26 on ADHD-RS-IV
* IQ of greater than or equal to 80
* Blood pressure measurements within 95th percentile for age, gender, height at screening and baseline

Exclusion Criteria:

* Current controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD)
* Known nonresponder to psychostimulant treatment
* BMI for age greater than 90th percentile
* History of seizures during last 2 years
* Conduct Disorder
Evaluation of the Sphingolipid Metabolite S1P as a Novel Biomarker in Food Allergy

Food allergies represent an increasing health concern in the industrialized countries and especially affect pediatric patients. In this population adverse reactions against food compounds can lead to anaphylactic reactions. Despite substantial research efforts, clinical markers predicting disease severity and symptoms are missing to date.

Recent studies have revealed that sphingolipids, especially sphingosine-1-phosphate (S1P), play an essential role in allergy. It was reported that asthmatic patients have higher S1P levels in bronchiallavage fluids after allergen challenge. First experimental studies revealed a correlation of S1P and the outcome of anaphylaxis. Furthermore, we have shown in our recent mouse study that S1P homeostasis is pivotal for food allergy induction and effector cell response. Therefore, it is the aim of the presented pilot project to evaluate whether S1P serum titers are altered in food allergic children and if the S1P levels correlate with the outcome of anaphylaxis during double blind placebo controlled food challenges (DBPCFCs).


Eligibility Criteria:
Inclusion Criteria:

* Patients between 1-17 years who have been reported to suffer from food allergic reactions and who are subjected to DBPCFC or open provocation
* Patients who are diagnosed by elevated allergen specific IgE and/or positive skin prick testing
* Willingness to participate in the study

Exclusion Criteria:

* Refusal to participate in the study
* Non-IgE-mediated food allergy
Does Body Positioning Affect the Yield of Hyperventilation in Routine Pediatric Electroencephalography - EEG Studies?

Children referred for routine EEG studies for suspected absence seizures will be asked, upon caregiver's informed consent, to perform 3 minutes of hyperventilation both in the supine position and while sitting up. We aim to demonstrate that hyperventilation is more effective in eliciting absence seizures in a sitting position than while lying down.

Hyperventilation is a very effective means of eliciting absence seizures in children with absence epilepsy. Worldwide EEG protocols for routine EEG recording include 3 minutes of hyperventilation. The whole EEG recording, including hyperventilation, is performed with the child lying down on a bed/coach. Our clinical experience suggests that the body position may affect the yield of hyperventilation in provoking the absence event. That is, hyperventilation may be more effective when the child is sitting up, Therefore, children referred for a routine EEG for suspected absence seizures will add 3 minutes of hyperventilation on a sitting position to the routine 3 minutes of supine hyperventilation. At least 5 minutes of rest will be allotted between both procedures.

Patients' caregivers will sign an informed consent form. Patients will randomly be divided into 2 groups: one group will first perform supine hyperventilation followed by sitting hyperventilation; the second group will perform hyperventilation in the opposite order, ie, first sitting up and then in supine position.

Eligibility Criteria:
Inclusion Criteria:

* Children referred for a routine EEG for suspected absence epilepsy

Exclusion Criteria:

* Patients unable to perform hyperventilation
* Children previously diagnosed with absence epilepsy
* Children receiving antiepileptic drugs
Clinical Effectiveness of Enteric Coated(E.C.) Anise-oil on Irritable Bowel Syndrome

Colpermin ® (Peppermint oil) is used in the treatment of Irritable Bowel Syndrome but Peppermint (Mentha x piperita) isn't native in Iran. So in this study the Enteric-Coated of Anise-oil will formulate and use in treatment of Irritable Bowel Syndrome with pain and bloating.

The purpose of this study is to assess the efficacy of Enteric-coated Anise-oil capsules comparing with placebo and Colpermin® for treatment of IBS patients. 120 patients with confirmed IBS with non-response criteria selected. In this double blind pilot study, the patients and researchers will be blinded about Receiving Drug, Placebo and Active allocation. Patients will be randomized into group A (Anise-oil EC Capsule 187 mg daily, for 4 weeks), group B (placebo Capsule once daily, for 4 weeks) and group B (Colpermin® Capsule once daily, for 4 weeks). At the end of therapy (4 weeks) and at baseline (first), 2 weeks after receiving drug, placebo and Colpermin® IBS load, will be evaluated and compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Meeting the Rome III Modular Questionnaire
* Patients with 50 years were required to have a colonoscopy performed within the previous 5 years
* Patients under the age of 50 years were required to have a sigmoidoscopy performed

Exclusion Criteria:

* Unable or unwilling patients to use an acceptable method of birth control
* Pregnant or nursing females
* Previous gastrointestinal or abdominal surgery (except for common causes unrelated to IBS)
* Organic disorder of the large or small bowel (e.g. ulcerative colitis, Crohn's disease)
* Mechanical obstruction
* Unexplained significant weight loss or rectal bleeding
* Diagnosis of any medical condition associated with constipation (other than IBS)
* Cancer
* Abnormal laboratory tests
* Abuse of alcohol or drugs
A Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-T-cell Immunoreceptor With Ig and ITIM Domains (TIGIT) Monoclonal Antibody Injection (IBI939) in Subjects With Advanced Malignant Tumors

This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI939 in subjects with advanced malignancies


Eligibility Criteria:
Inclusion Criteria:

1. Able to understand and willing to sign the ICF.
2. Adults 18 years of age or older.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy at least 12 weeks.
5. Adequate organ and bone marrow function.

Eligibility Criteria：

1. Previous exposure to any anti-TIGIT antibody.
2. Participate in another interventional clinical study, except for the observational (non-interventional) clinical study or the survival follow-up phase of the interventional study.
3. Any investigational drugs received within 4 weeks prior to the first study treatment.
4. Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
5. Immunosuppressive drugs were used within 4 weeks prior to the first administration of the study drug.
6. Medication requiring long-term systemic hormones or any other immunosuppression therapy.
7. Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures were performed within 4 weeks prior to the first dose of study therapy.
8. Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases, or leptomeningeal disease.
9. History of autoimmune disease , present active autoimmune disease or inflammatory diseases
10. Positive human immunodeficiency virus (HIV) test.
11. Active hepatitis B or C, or tuberculosis.
12. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
13. Known history of hypersensitivity to any components of the IBI939 or Sintilimab.
14. Pregnant or nursing females.
Microelectrodes in Epilepsy

The purpose of this study is to test microelectrodes in intracranial monitoring to see if they will provide novel information on the epileptic potential of the implanted brain tissue. A secondary objective is to investigate the activity of single neurons during specific cognitive tasks.

The standard-of-care for medically refractory epilepsy is resective brain surgery. In certain patients, precise localization of the epileptic focus is done using intracranial EEG (iEEG) recording. In this type of EEG recording, electrodes are placed on the brain surface or inserted into the brain through an opening in the skull. In addition to standard electrode recording, this study will use ultra thin microelectrodes. Microelectrodes are only several micrometers thick and are useful because they are able to record the activity of single neurons in isolation. Such recordings have tremendous clinical potential in epilepsy surgery and tremendous research potential in cognitive neuroscience.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 year old
* male or female
* right or left handed
* IQ\>70
* medically refractory focal epilepsy requiring intracranial EEG for pre-surgical evaluation deemed medically necessary
* no contraindications to intracranial electrode study
* able and willing to participate in research

Exclusion Criteria:

* does not meet the inclusion criteria
Safety and Efficacy of ThisCART19 in Patients With Refractory or Relapsed B Cell Malignancies

This is a study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell malignancies.

This is a single-center, nonrandomized, open-label study to evaluate the safety and clinical activity of ThisCART19 in patients with refractory or relapsed CD19 positive B cell malignancies, such as acute or chronic lymphocytic leukemia, lymphoma and etc. The dose range is 0.2-60 x 10\^6 cells per kg body weight.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with relapsed or refractory CD19 positive acute or chronic lymphocytic leukemia, or lymphoma.
2. No alternative treatment options deemed by investigator.
3. Measurable or detectble disease at time of enrollment.
4. Eastern cooperative oncology group (ECOG) performance status of ≤2.
5. Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO).
6. Estimated life expectancy \> 12 weeks deemed by investigator.
7. Serum creatinine ≤1.6 mg/dl and/or blood urea nitrogen(BUN) ≤ 1.5 mg/dl .
8. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 5 upper limit of normal (ULN).
9. Informed consent explained to, understood by and signed by patient/guardian.

Exclusion Criteria:

1. Pregnant or lactating women
2. Uncontrolled infection
3. Active hepatitis B virus or hepatitis C virus infection.
4. Patients who need steroids to control disease.
5. Patients who accepted autologous stem-cell transplantation (ASCT) within 100 days.
6. Patients with grade 2-4 graft-versus-host disease (GVHD), or deemed need to manage by investigator.
7. History of Human Immunodeficiency Virus (HIV) infection.
8. Patients with active central nervous system (CNS) involvement by malignancy.
9. Patients combine with other disease cause neutrophil count (ANC) \< 750 per microlitre or platelet count (PLT)\< 50,000 per microlitre.
Optimizing Patient Usability Experience for Chronic Care

The study aims to develop a module of an eHealth platform, do a feasibility study through a pilot cluster randomized control trial and assess the scalability of the solution.

Multimorbidity increases care needs and primary care use among people with chronic diseases (1). The Concerto Health Program (CHP) has been developed to optimize chronic disease management in primary care services. However, in its current version, the CHP primarily targets clinicians and does not aim to respond directly to the needs of patients and their informal caregivers for chronic disease management . This project aims to develop, implement and evaluate a user-centered, multifunctional and personalized eHealth platform (CONCERTO+) to promote a more active patient role in chronic disease management and decision-making through three phases.

For phase1: A first prototype will be developed by the design and technology teams, in close collaboration with researchers, health professionals and patient representatives who will identify the functionalities to include in the CONCERTO+ solution.

The Phase 2 of the project will consist in a feasibility study based on a pilot cluster randomized clinical trial (c-RCT) where patients with chronic diseases from a primary healthcare practice will receive CONCERTO+ and be compared to patients from a control practice receiving usual care.

For Phase 3, the analysis of CONCERTO+ potential for scaling-up will be done by documenting factors and conditions associated with the sustainability and scaling-up of the solution. To do so, the investigators will conduct: 1) two focus groups with patients and informal caregivers who participated in the study (one with the experimental group and one with the control group, each group gathering between eight and twelve participants); 2) semi-structured individual interviews with health professionals at the two study sites, as well as with health care managers, information officers, and representatives of the Ministry of Health and Social Services.

Eligibility Criteria:
Inclusion Criteria:

* Having one or more targeted chronic diseases (diabetes, hypertension, dyslipidemia)
* had 3 or more visits in the last 12 months
* having an interest in health and technologies,
* be able to read and speak in French

Exclusion Criteria:

* Majors whose incapacity has been recognised judically