cyrilzakka/clinical-trials huggingface dataset:
An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Inclusion Criteria:

* Is not in clinical response or clinical remission after completing 12 weeks in the Induction Studies
* Experience relapse or who complete the Maintenance Study
* Complete a study of ozanimod for Crohn's Disease and meet the criteria for participation

Exclusion Criteria:

* Has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study
* Has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated
* Is receiving treatment with any of the following drugs or interventions: CYP2C8 inducers; Monoamine oxidase inhibitors

Other protocol-defined inclusion/exclusion criteria apply
A Dye for the Detection of Cancer of the Tongue and Mouth

The purpose of this study is to test if an investigational dye, called PARPi-FL, can be used to detect this type of cancer. This will be the first time that PARPi-FL is being tried in people. First, the investigators will test the safety of PARPi-FL at different doses to find out what effects, if any, it has on people. The investigators will also see which amount of PARPi-FL is best suited to detect cancers of the mouth and tongue.


Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years old
* Histologically or cytologically proven squamous cell carcinoma of the oral cavity or pharynx (OSCC)
* Scheduled to undergo surgery at MSK
* Any tumor stage, any N, M0
* ECOG performance status 0 or 1

Exclusion Criteria:

* Any surgical therapy in the area of the oral cavity or pharynx within the last 2 weeks
* Prior or ongoing treatment with a PARP1 inhibitor
* Known hypersensitivity to Olaparib
* Known hypersensitivity to PEG Eligibility criteria will be assessed by an experienced oral surgeon, typically the Co-PI of the study.
Navigation and Positioning System for Orthopedic Surgery

This clinical trial is a prospective, multicenter, non inferiority, randomized controlled trial. We plan to include 112 subjects in China and randomly assign them to the experimental group and the control group according to the ratio of 1:1. The experimental group used the orthopedic surgery navigation and positioning system produced by Nanjing Tuodao Medical Technology Co., Ltd., while the control group used the orthopedic surgery navigation and positioning system produced by Beijing tianzhihang Medical Technology Co., Ltd. Taking the position deviation of Kirschner wire as the main evaluation index, it was proved that the test instrument was not inferior to the control instrument. The test data shall be submitted to the State Drug Administration for approval of the marketing license of the test device


Eligibility Criteria:
Inclusion Criteria:

1. They were 18-75 years old;
2. From thoracic vertebrae to lumbar vertebrae, pedicle screw fixation is needed;
3. Signed informed consent, willing to receive treatment and follow-up according to the requirements of the trial protocol.

Exclusion Criteria:

1. Patients with pedicle deformity.
2. Patients with severe osteoporosis.
3. Patients with spinal tumor or tuberculosis.
4. Patients with abnormal liver function (alanine aminotransferase, aspartate aminotransferase values \> 3 times of the upper limit of the normal range) and abnormal renal function (creatinine values \> 3 times of the upper limit of the normal range).
5. Patients with abnormal coagulation function (prothrombin time, activated partial thromboplastin time \> 1.5 times of the upper limit of normal range).
6. Pregnant or lactating women.
7. Patients with mental disorders.
8. The investigators evaluated patients who were not suitable for pedicle screw fixation.
9. Patients who are participating in clinical trials of any other device or drug.
10. Poor compliance, difficult to cooperate with patients who complete treatment and follow-up.
Retrospective Follow-up Study of Synvisc® in Patients With Knee Osteoarthritis

Retrospective collection of data, aimed at a better knowledge of the use of Synvisc® among the patients with knee osteoarthritis (OA) since at least three years.


Eligibility Criteria:
Inclusion Criteria:

* Patients with knee osteoarthritis using Synvisc® since at least three years

Exclusion Criteria:

* none
A Study Evaluating the Efficacy of QGE031 Compared to Omalizumab in Patients With Allergic Asthma

This study will evaluate the efficacy of QGE031 compared to omalizumab in patients with allergic asthma. Each treatment's effect in changing the concentration of inhaled allergen that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at 12 weeks compared to baseline will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

Adult patients 18 to 65 years

Positive skin prick test to one or more common airborne allergens

Presence of airway hyperresponsiveness documented by a provocative concentration of methacholine causing a 20% fall in FEV1 (PC20 FEV1) of less than or equal to 16 mg/mL

Presence of an early asthmatic response demonstrated by an allergen challenge at screening and including a 15% fall in the FEV1

Patients with a body weight and total IgE in a range specified by local country prescribing information for omalizumab

Exclusion Criteria:

Pregnant or nursing (lactating) women

Women of child-bearing potential unless they are using a highly effective method of birth control (as further defined in the study protocol)

Smokers

Patients with poorly controlled asthma or patients who have had an asthma exacerbation within the past year

Other protocol-defined inclusion/exclusion criteria may apply.
Comprehensive Magnetic Resonance in Peripheral Arterial Disease.3

The goal is to test the ability to detect improved calf muscle perfusion and energetics in PAD patients in a randomized controlled trial of home exercise therapy. Eighty patients will be randomized to a 12 week home exercise program or no program (control).

The goal is to test the ability to detect improved calf muscle perfusion and energetics in PAD patients in a randomized controlled trial of home exercise therapy. Eighty patients will be randomized to a 12 week home exercise program or no program (control). Patients will be studied before and after program completion with MRI/MRS, calf muscle biopsy for capillary density, and exercise performance measures. Arterial spin labeling peak exercise calf muscle perfusion will be used as the primary endpoint in the most symptomatic leg. All will undergo ASL, peak exercise PCr recovery kinetics, calf muscle biopsy, and functional measures including treadmill exercise, VO2 testing, and 6-minute walk. Correlations will be examined between changes in perfusion and energetics with changes in capillary density, peak VO2, and functional capacity from before to after completion of home exercise therapy.

Eligibility Criteria:
Inclusion Criteria:

* Documented ABI 0.5-0.9
* Ability to walk on treadmill

Exclusion Criteria:

* Lower extremity vascular surgery, angioplasty or lumbar sympathectomy within 3 months of enrollment
* Critical limb ischemia
* Known or suspected peripheral neuropathy, heel cord contracture and foot deformity
* Other conditions that limit walking, e.g. lung disease or arthritis
* Active coronary artery disease such as unstable angina, significant left main disease or three vessel coronary artery disease (\>70% stenosis, unprotected by grafts) or recent (\<2 months) myocardial infarction,
* BMI \> 40,
* Known contraindication to MRI (intracardiac pacer, defibrillator, certain intracranial aneurysm clips, intraocular or cochlear implants, claustrophobia, etc.)
* Allergy to lidocaine or xylocaine (local anesthetic)
Effectiveness of Triple Therapy in COPD

To assess the effectiveness of maintenance treatment of Chronic obstructive pulmonary disease (COPD) with the Long-acting beta2-agonist - long-acting muscarinic antagonists-inhaled corticosteroids (LABA-LAMA-ICS) combination with a LABA-LAMA combination on the risk of COPD exacerbation and the safety on the incidence of community acquired pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* New users of long-acting bronchodilators, Long-acting beta2-agonist (LABA) and long-acting muscarinic antagonists (LAMA) on the same date or of LABA, LAMA and inhaled corticosteroids (ICS), either as a fixed-dose combination (LABA-ICS) or free combination, on the same date between January 2002 and December 2016.
* Diagnosis of Chronic obstructive pulmonary disease (COPD) prior to first maintenance inhaler and age ≥ 55 years at first maintenance inhaler.

Exclusion Criteria:

* Less than one year of medical history information prior to the date of combined treatment initiation (study cohort entry)
* Asthma diagnosis prior to study cohort entry
Merging Yoga and Self-Management Skills for Symptoms of Long COVID

Long COVID patients experience high symptom burden for many months after initial infection of the COVID-19 virus. This study will investigate a mobile intervention Merging Yoga and Self-Management Skills (MY-Skills Mobile) as a complementary therapy for fatigue, pain, mood and quality of life in long COVID patients at the UCHealth Center for Integrative Medicine. The study aim is to assess the feasibility and acceptability of MY-Skills Mobile and research procedures including planned assessments.


Eligibility Criteria:
Inclusion Criteria:

* patients referred to the UC Health Integrated Medicine Clinic for long COVID
* community-dwelling
* speak English
* able to provide informed consent
* stand with or without an assistive device
* complete the Exercise Assessment and Screening for You (EASY) tool; potential participants will receive instructions about safe physical activity and/or to obtain physician approval prior to enrollment.

Participants will not be excluded due to limited technology access. We will loan tablets and hotspots to participants who do not have hardware or internet.

Exclusion Criteria:

* current yoga ≥120 minutes a week
* completed self-management education in the last year
* cognitive impairment limiting participation in decision making
A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma

To provide Therasphere treatment for patients diagnosed with unresectable liver cancer.


Eligibility Criteria:
Inclusion Criteria:

Patients of any age, of any race or sex, who have hepatocellular carcinoma of the liver, and who are able to give informed consent, will be eligible. Patients must have an ECOG Performance Status score of \</= 2, with a life expectancy of \>/= 3 months, non-pregnant with an acceptable contraception in premenopausal women. Patients must be \>4 weeks since prior radiation or prior surgery and at least 1 month post other chemotherapy.

Exclusion Criteria:

* Contraindications to angiography and selective visceral catheterization
* Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs
* Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (ex. placing catheter distal to gastric vessels)
* Significant extrahepatic disease representing an imminent life-threatening outcome
* Severe liver dysfunction or pulmonary insufficiency
* Active uncontrolled infection
* Significant underlying medical or psychiatric illness
* Pregnancy

Patients will be excluded: if they have a co-morbid disease or an acute or chronic condition that would preclude safe delivery of TheraSphere treatment and place the patient at undue risk.
MyeloGen: Germline Testing for Predisposition to Myeloid Malignancies

This research study is evaluating the feasibility of conducting cancer genetic testing using healthy skin cells among participants with a diagnosis of a blood cancer. Additionally, investigators will evaluate how often participants with blood cancers are found to have risk for cancer based on family genes.

The purpose of this prospective, non-randomized, non-therapeutic, single arm study is to determine the feasibility and benefit of performing genetic testing for all participants with a blood cancer diagnosis regardless of clinical suspicion.

Research study procedures include screening for eligibility, in-clinic visits, questionnaires, and skin punch biopsies. Participants will receive germline genetic testing with a comprehensive hereditary cancer gene panel.

It is expected that about 200 individuals with blood cancer will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or older
* Participants must have histologically confirmed myeloid malignancy OR bone marrow failure within the last 6 months prior to screening.
* Ability to understand and provide a signed and completed consent document in English or Spanish.

Exclusion Criteria:

* Patients with who cannot safely undergo skin biopsy as adjudicated by the study team.
* Patients who have previously undergone germline genetic testing for predisposition to myeloid malignancies
Egg Quality Assessment

The goal of this observational study is to learn about egg physiology in humans.

The main question it aims to answer is if there is an association between egg physiology and egg quality.

Discarded, unfertilised eggs and follicular fluid collected during routine egg retrieval from participants undergoing in vitro fertilisation (IVF) as part of their regular medical care along with information from participants' electronic medical records will be collected and analysed.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing in vitro fertilisation treatment or egg freezing

Exclusion Criteria:

* No discarded, unfertilised eggs for collection
Efficacy and Safety Study of Neramexane to Treat Congenital and Acquired Nystagmus

The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN) in comparison to placebo. In addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be included; this subgroup will be analyzed in an exploratory manner only.


Eligibility Criteria:
Inclusion Criteria:

* patients with congenital idiopathic nystagmus or acquired nystagmus subsequent to multiple sclerosis
* male or female outpatients
* aged between 18 and 80 years (inclusive) at screening

Exclusion Criteria:

* patients with evidence of neurologic disorders other than CIN such as congenital nystagmus due to albinism or retinal diseases and/or acquired nystagmus (exemption: secondary to MS)
Artificial Inteligence in Endoscopic Ultrasound

The objective of the study is to determine if this artificial intelligence system is capable of detecting abnormalities in the pancreas that are identified by an endoscopist at endoscopic ultrasound procedures.

Endoscopic Ultrasound (EUS) is an equipment where an ultrasound transducer is attached to the tip of the endoscope. When advanced to the stomach the organs outside such as the pancreas and liver can be visualized in great detail. This enables diagnosis of conditions such as pancreatic cancer. However, an endoscopist must undergo training to accurately interpret these ultrasound images.

The investigators are in the process of developing an artificial intelligence system that could potentially interpret EUS images. The objective of the study is to determine if this artificial intelligence system is capable of detecting abnormalities in the pancreas that are identified by an endoscopist at endoscopic ultrasound procedures. Such correlation if established will lead to possible development of an artificial intelligence platform that can diagnose pancreatic diseases. Such development will potentially minimize human error and decrease learning curve to gain proficiency in EUS.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Any patient undergoing endoscopic ultrasound examination

Exclusion Criteria:

* Age \< 18 years
Sorafenib or Lenvatinib Plus HAIC of 130 mg/m² Oxaliplatin, and 5-fu vs Sorafenib or Lenvatinib Plus HAIC of 85mg/m² Oxaliplatin, and 5-fu for Unresectable Advanced HCC: a Randomised Phase 3 Trial

A randomized trial showed that sorafenib plus hepatic artery infusion of 85mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. However, a retrospective study showed that hepatic artery infusion of 130 mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. It is unknown which oxaliplatin dose is better.


Eligibility Criteria:
Inclusion Criteria:

* KPS≥70;
* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
* Patients must have at least one tumor lesion that can be accurately measured;
* With vascular invasion or extrahepatic metastasis
* Diagnosed as unresectable with consensus by the panel of liver surgery experts;
* No past history of TACE, HAIC, chemotherapy or molecule-targeted treatment;
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin

  ≥ 32 g/L;(e) ASL and AST ≤ 6 x upper limit of normal;(f) Serum creatinine

  ≤ 1.5 x upper limit of normal;(g) INR \> 2.3 or PT/APTT within normal limits; (h) Absolute neutrophil count (ANC) \>1,500/mm3;
* Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria:

* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Evidence of bleeding diathesis.
* Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug
Comparison of Two Insertion Technique of I-gel

To evaluate the efficacy of rotational technique in the insertion of i-gel

The i-gel is one of the 2nd generation supraglottic airways. The rotational technique is known to increase the success rate of insertion of other supraglottic airways. The investigators try to evaluate the efficacy of rotational technique in the insertion of i-gel.

Eligibility Criteria:
Inclusion Criteria:

- Patients scheduled for general anesthesia(transurethral resection of bladder tumor or transurethral resection of the prostate) using i-gelTM

Exclusion Criteria:

* History of recent postoperative sore throat
* History of difficult airway
* Mouth opening \< 2.5 cm
* Emergency operation
The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Lymphoma

This is a clinical study to observe the safety and feasibility of chimeric antigen receptor 19 (CART-19) cells in relapsed and refractory patients with CD19+ B cell lymphoma.

This is a study for the patients with B cell lymphoma. Subjects will be staged and the suitability of their T cells for CART-19 manufacturing will be determined at entry phase. Subjects will be collected their T cells and modify them, the modification is a genetic change, that CD19:4-1BB:CD3 modified T cells, in order to tells the T cells to recognize their target tumor cells and potentially kill them, but not other normal cells in the subject's body. The CART cells will then be expanded in vitro and then administered to subjects.

The purpose of this study is to assess ssess the safety and feasibility of CART-19 cells in the patients with relapsed and refractory CD19+ B cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years to 70 years, expected survival \> 3 months;
2. CD19 positive B-cell lymphoma;
3. KPS \>80;
4. Having at least one measurable lesions;
5. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN; bone marrow: WBC ≥ 3.0×109/L, Hb ≥90 g/L, PLT ≥ 80×109/L）;
6. No serious allergic constitution;
7. No other serous diseases that conflicts with the clinical program;
8. No other cancer history;
9. No serious mental disorder;
10. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

1. Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test);
2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
3. Active hepatitis B or hepatitis C infection;
4. Recent or current use of glucocorticoid or other immunosuppressor;
5. With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
6. Transaminase \>2.5ULN, Bilirubin \>3ULN，Creatinine\>1.25ULN
7. Participate in other clinical research in the past three months; previously treatment with any gene therapy products;
8. Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results;
Prostate Specific Antigen Levels of Individuals Living in Rural Areas

It was planned in cross-sectional design in order to determine the specific prostate antigen level and some characteristics and the relationship evaluations and prostate specific antigen formation in individuals living in rural areas. It was planned to perform socio-demographic information formula, form including social information of health, prostate specific antigen test in the project data recording.

It was planned in a cross-sectional design to evaluate the prostate specific antigen level and its relationship with some characteristics in elderly individuals living in rural areas and to determine the prostate specific antigen level. The research area of the project consists of 8 villages. In the collection of project data, it was planned to conduct a socio-demographic feature information form, a form including social determinants of health, and a prostate specific antigen test. This planned project is the first research to be conducted in our country in terms of determining risky groups, ensuring randomness in participants, and sampling method for universe representation. In addition, screening the rural area, which is disadvantaged in terms of socio-economic and demographic aspects, and preferring elderly individuals constitute the steps taken to ensure health equality of the disadvantaged group in terms of health service transportation opportunities.

Eligibility Criteria:
Inclusion Criteria:

* Male
* 55 years or older

Exclusion Criteria:

-Prostate treatment