cyrilzakka/clinical-trials huggingface dataset:
Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma

The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma

Five years after the last study participant is randomized, participants who have received axicabtagene ciloleucel will transition to a separate Long-term Follow-up study (study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.

Eligibility Criteria:
Key Inclusion Criteria:

* Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a)
* Relapsed/refractory (R/r) disease after first-line chemoimmunotherapy and high-risk disease with relapse or progression within 24 months of the initial course of chemoimmunotherapy (ie, POD24), Or r/r disease after ≥ 2 prior systemic lines of therapy
* Clinical indication for treatment.
* At least 1 measurable lesion per the Lugano Classification {Cheson 2014}
* Adequate renal, hepatic, pulmonary, and cardiac function

Key Exclusion Criteria:

* Presence of large B cell lymphoma or transformed FL
* Small lymphocytic lymphoma
* Lymphoplasmacytic lymphoma
* Full-thickness involvement of the gastric wall by lymphoma
* FL Grade 3b
* Prior CD19-targeted therapy
* Prior CAR therapy or other genetically modified T-cell therapy
* Uncontrolled fungal, bacterial, viral, or other infection
* Active Infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus
* History or presence of a clincially significant central nervous system (CNS) disorder.
* History of autoimmune disease
* Known history or CNS lymphoma involvement
* Cardiac lymphoma involvement
* History of clinically significant cardiac disease 6 months before randomization
* Neuropathy greater than grade 2
* Females who are pregnant or breastfeeding
* Individuals of both genders who are not willing to practice birth control
* Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, G/J-tube, pleural/peritoneal/pericardial catheter, or Ommaya reservoirs). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheter are permitted.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Phase I Study in Advanced Solid Tumors

Dose escalating study of orally administered indibulin at twice daily schedule in subjects with solid tumors.


Eligibility Criteria:
Inclusion Criteria

1. Subjects with histological or cytological confirmation of advanced cancer, refractory to standard therapies for their condition
2. ≥ 18 years of age
3. ECOG performance score ≤ 2 (see Appendix 3)
4. Eligible subjects MUST have at least one measurable lesion as defined by RECIST guidelines (See Appendix 4). If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology. Measurable lesions MUST not have been in a previously irradiated field or injected with biological agents.
5. Life-expectancy ≥ 12 weeks
6. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted \< 2 weeks prior to Baseline:

   * Creatinine ≤ 1.5 X upper limit of normal (ULN) OR a calculated creatinine clearance ≥ 50 cc/min
   * Total bilirubin ≤ 1.5 X ULN
   * Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 X ULN
   * White blood cell count ≥3.0 x 109/L
   * Absolute Neutrophil Count (ANC) ≥1.5 x 109/L
   * Platelets ≥100 x 109/L
   * Hemoglobin ≥ 10 g/dL
7. Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee with jurisdiction over the site.

Exclusion Criteria

1. New York Heart Association (NYHA) functional class ≥3 or myocardial infarction within 6 months (see Appendix 5)
2. Uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation
3. Pregnant and/or lactating female (a reliable method of contraception must be used in all men and in women of childbearing potential during the study and for 3 months after last study drug administration).
4. Uncontrolled systemic infection (documented with microbiological studies)
5. Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry. Mitomycin C or nitrosureas should not be given within 6 weeks of study entry.
6. Radiotherapy during the study or within 3 weeks of study entry
7. Surgery within 4 weeks of start of study drug excluding tumor biopsy for pharmacodynamic parameters
8. Investigational drug therapy outside of this trial during or within 4 weeks of study entry
9. History of an invasive second primary malignancy diagnosed within the previous 3 years except for Stage I endometrial/cervical carcinoma or prostate carcinoma treated surgically, and non-melanoma skin cancer
10. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
11. Any condition that is unstable or which could jeopardize the safety of the subject and his/her compliance with the study protocol.
Safety and Efficacy Evaluation of Two Different Brilliant Blue G Dyes as Staining Agent in Vitreo Retinal Surgery.

This is a prospective, Open-label, comparative clinical study to asses two brilliant blue G dyes as staining agent in Vitro Retinal Surgery.

The study was designed as prospective, open label, comparative observational study. The patients over 18 years old and undergone Macular Surgery, Internal Limiting membrane removal surgery or vitreomacular traction using the two brilliant blue G dyes as staining agent in Vitro Retinal Surgery were planned to enroll the study. Two blue G dyes (Bio Blue 90 plus and ILM Blue) was randomly assigned at the subject's initial intraoperative visit, according to a computer-generated randomization schedule. During the pars plana vitrectomy, Bio Blue 90 Plus or ILM Blue dyes were injected into eye to stain ILM. Injected Dye was removed from the eye at the end of study before injecting long term tamponade. A total of 5 visits were conducted during the study. Out of them pre-operative visit was done on 1 visit, Surgery/Intraoperative visit and thereafter there were three follow-up visits. The follow- up visits were performed at 1 month, 3 months and 6 Months after the completion of Surgery. Clinical evaluation will be done recording and using staining Ability of ILM (Intra-Operatively), Visualization of Stained Membrane (Intra-Operatively),OCT parameters: (Pre-Op \& Post-Op Follow-Up), FFA parameters: (Pre-Op \& Post-Op Follow-Up),Fundus auto fluorescence (FAF), Multifocal ERG (Pre-Op \& Post-Op Follow-Up) and Visual Field analyses (Pre-Op \& Post-Op Follow-Up).

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Patient undergone Macular Surgery, Epiretinal membrane removal surgery or vitreomacular traction using the study device
* Patient who can attend all the regular follow-up examinations as per the routine schedule.
* Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read signed and dated by the patient.

Exclusion Criteria:

* Standard exclusion criteria for Macular Surgery like trauma history, previous macular surgery, rhegmatogenous retinal detachment together with macular hole, myopia higher than 10 diopter (D), macular hole for more than 2 years and previous retinal vessel disease.
* Participated in any study during the use of the study device.
Improvement Mental Health Among Physicians by a Mindfulness-training Mobile Application

The aim of our study was to evaluate the effect of a short, smartphone-based mindfulness application on stress, wellbeing and burnout among hospital physicians

Physicians working at a tertiary hospital were recruited and randomly divided into two groups, a study group (SG) in which participants practiced mindfulness through the application for 6 weeks and a control group (CG). Main Measures: All participants filled-out questionnaires assessing stress (Perceived Stress Scale-PSS), mental health (Mental Health Inventory-MHI) and burnout (Maslach Burnout Inventory-MBI) at baseline and 7 weeks later

Eligibility Criteria:
Inclusion Criteria:

\* Physicians Working full-time at the Rambam Healthcare Campus.

Exclusion Criteria:

\* Physicians that won't be able to participate in at least 50% of the practicing.
Interscalene and Combined Supra Scapular and Axillary Nerve Blocks in Rotator Cuff Repair

Primary objective of this study is to prospectively compare and evaluate efficacy as well as note side effects of the interscalene block and combined suprascapular and axillary nerve block for ambulatory arthroscopic rotator cuff repair.

Patients having elective arthroscopic rotator cuff repair will be randomized to one of the two groups.

Group 1: This group will receive Interscalene block (ultrasound guided and nerve stimulator aided) followed by a general anesthesia.

Group 2: This group will receive Suprascapular and Axillary nerve block (ultrasound guided and nerve stimulator aided) followed by a general anesthesia.

Performance time, quality and efficacy as well as any side-effects of the blocks will be evaluated in terms of pain scores in recovery room, after 4- 6 hours and the next morning, opioid usage and patient satisfaction.

Primary hypothesis:

• Combined Suprascapular and axillary nerve blocks provide similar postoperative analgesia as compared to interscalene block for arthroscopic rotator cuff repair.

Secondary hypothesis

• Interscalene block is associated with more side effects and complications as compared to suprascapular nerve block and axillary nerve block.

Eligibility Criteria:
Inclusion Criteria:

* Elective shoulder arthroscopic rotator cuff repair
* ASA I - III (American Society of Anaesthesia Classification)

Exclusion Criteria:

* ASA IV or higher ( American Society of Anaesthesia Classification)
* Obesity: BMI \>35
* Narcotic Abuse/ Drug dependency
* Major Neurologic deficits
* Allergy to local anesthetics
* Infection in the site of the puncture
* Mental impairment
The COLIC Study: Colonization of the Infant Gut With B. Infantis EVC001 to Reduce Symptoms of Colic

To investigate whether B. infantis EVC001 colonization in the infant gut can reduce symptoms of colic

There is evidence to support that B. infantis EVC001 supplementation may ameliorate symptoms associated with colic by establishing and maintaining the necessary gut microbial composition to promote proper barrier and immune function in infants. The primary objective of this study is to assess the effect of the probiotic, B. infantis EVC001, on reducing the duration of crying/fussing symptoms of breastfed infants diagnosed with infantile colic from Baseline to Day 14.

Eligibility Criteria:
Inclusion Criteria:

* Infants with a diagnosis of infantile colic per Rome IV criteria and reported to cry/fuss for ≥ 3 hours/day, within a 24-hour period as determined by the 24-hour cry/fuss eDiary AND 24 hours of LENA vocalizations
* Infants with a gestational period of ≥ 37 to 42 weeks
* Infants between 14 and ≤ 42 days of life at the completion of screening/baseline tasks
* Infants exclusively breastfed for at least 7 days immediately prior to enrollment and with mother's intent to continue feeding breast milk exclusively for the duration of the study
* Mothers willing to use their own electronic device(s) to download and utilize all required study software (decentralized trial platform on a mobile device and the LENA device software on a Windows 10 or higher laptop or desktop that has at least 10 GB of free space and fast, reliable internet)
* Mother is fluent in English

Exclusion Criteria:

* Infants born in multiple birth (i.e., twins, triplets, etc.)
* Infants born with medical complications (i.e., neurological, cerebral palsy, confirmed food allergies)
* Infants with current evidence of failure to thrive, fever, or illness
* Infants with any GI tract abnormalities
* Antibiotic, infant formula, solid food or iron supplement intake within 7 days prior to enrollment or mother's intent to feed non-study probiotics, prebiotics, infant formula, solid food or iron supplements to their infant at any time during the study
* Infants who have consumed any probiotics since birth
* Unwillingness to discontinue/avoid products used to treat IC (i.e., Simethicone, gripe water, colic drops, etc.) during the study. Note: consumption of IC products prior to the baseline period is NOT exclusionary
* Maternal use of probiotics containing B. infantis during pregnancy, after the baby's birth and/or intent to use probiotics containing B. infantis at any time throughout the study
* Maternal smoking or smoking within the home by any household member currently or during pregnancy
* Mother following exclusionary diet due to her infant's colic (i.e., dairy elimination diet)
* Any infant the Investigator deems to be ineligible for participation
Pilot Study to Test the Feasibility of the Use of MRI in Suspected Scaphoid Fractures

This pilot study aims to test the feasibility and work flows associated with using MRI as the initial imaging modality in the investigation of patients presenting with suspected scaphoid fracture.

This pilot will be used to inform the design of a study that will aim to evaluate whether the proposed intervention is likely to generate cost-savings whilst improving or maintaining overall patient quality of life and satisfaction.

The present pilot study is designed to assess the feasibility of using MRI as the initial imaging modality in the investigation of patients presenting with suspected scaphoid fracture at the Emergency department or Urgent Care Centre. This study will inform the design of a study that will aim to evaluate whether the proposed intervention is likely to generate cost-savings whilst improving or maintaining overall patient quality of life and satisfaction.

Patients with a suspected scaphoid fracture will be randomised to receive standard of care using 4-view plain x-ray (control group) as the first imaging modality or MRI examination as the first imaging modality.

Eligibility Criteria:
Inclusion Criteria:

* Patients considered to be suitable for the proposed pathway include every patient aged 16 years old or above, presenting at A\&E/UCC between 8:00am and 4:00pm (Monday to Friday), with at least one of the following:
* Isolated pain / tenderness over the Anatomical Snuff Box (ASB) or scaphoid tubercle or pain in the scaphoid region during axial loading of the 1st metacarpal.
* History of recent fall (\< 14 days) on out-stretched hand (FOOSH), wrist injury or poor history associated with examination findings suggestive of scaphoid fracture.

Exclusion Criteria:

* Patients presenting outside GSTT's catchment area not willing to be followed-up at GSTT;
* Patients without suspected scaphoid fracture following an initial A\&E/UCC clinical triage;
* Patients with scaphoid fracture not admitted through A\&E at St Thomas' Hospital or Urgent Care Centre at Guy's Hospital;
* Patients presenting at ED/UCC on weekdays (Monday to Friday) before 8:00am or after 4:00pm
* Patients presenting at ED/UCC on weekends or Bank Holidays;
* Patients who lack capacity to give consent or participate in the study;
* Patients that are already taking part in a clinical trial of an investigational medicinal products (CTIMPs);
* Patient is unable or unsuitable to MRI
Combined Therapy in Radiation Proctopathy

The aim of this study was to compare the efficacy and safety of two treatment regimens: argon plasma coagulation (APC) alone and APC in combination with sucralfate administered for chronic hemorrhagic radiation proctopathy.

Chronic radiation proctopathy (CRP) or proctosigmoiditis is a late complication of pelvic radiotherapy. Symptoms, including diarrhea, rectal bleeding, urgency, and tenesmus, are difficult to treat and adversely impact patient quality of life. Various treatments directed at the reduction of blood loss and improvement of other symptoms have been evaluated, with the most encouraging results reported for two methods: endoscopic argon plasma coagulation (APC) of radiation-induced abnormal vessels in the rectal mucosa, and administration of sucralfate, a drug believed to enhance the mucosal defense and healing when administered orally or rectally. Adequately powered randomized trials comparing various treatments are lacking, and an optimal management strategy has yet to be determined. To address this issue, we conducted a single-center, randomized, placebo-controlled, double-blind study comparing the efficacy and safety of APC alone and APC in combination with sucralfate administered orally.

Eligibility Criteria:
Inclusion Criteria:

* radiotherapy due to pelvic tumors completed at least three months prior to enrollment
* presence of rectal bleeding
* radiation-induced telangiectasia in the rectum and/or sigmoid colon on endoscopy
* informed written consent to participate in the study

Exclusion Criteria:

* history of clinically significant rectal bleeding prior to radiotherapy
* conditions predisposing the patient to rectal bleeding including inflammatory bowel disease, tumors of the large bowel, intestinal vascular lesions (other than radiation-induced telangiectasia), and diversion of the fecal stream
* sucralfate treatment during the two weeks prior to enrollment
* renal insufficiency (creatinine level ≥2 mg/dl)
* concurrent chemotherapy
* concurrent therapy with tetracycline, fluoroquinolones, or antimycotic drugs (because of drug interaction)
* concurrent therapy with oral anticoagulants
Anterior Suprascapular Nerve Block is an Effective and Diaphragm Protective Approach for Arthroscopic Shoulder Surgery

Interscalene block is still the gold standard in shoulder surgery analgesia. The most important side effect is diaphragm paralysis due to the phrenic nerve being affected. It may cause symptomatic dyspnea, especially in patients with limited respiratory capacity. There are studies showing that an effective analgesia, as much as the interscalene block can do, can be provided by blocking the suprascapular nerve in the neck region.

The aim of our study is to show that the anterior suprascapular block applied with ultra-low volume (5ml) in shoulder arthroscopy operations is at least as effective as the interscalene block and does not cause diaphragm paralysis.

Interscalene block is still the gold standard in shoulder surgery analgesia. The most important side effect is diaphragm paralysis due to the phrenic nerve being affected. It may cause symptomatic dyspnea, especially in patients with limited respiratory capacity. More distal brachial plexus blocks have been defined to avoid diaphragmatic paralysis . Thus, it is aimed to apply the local anesthetic drug further from the phrenic nerve. With the application of ultrasound, the amount of local anesthetic drug was reduced to less than 20 ml.

There are studies showing that an effective analgesia, as much as the interscalene block can do, can be provided by blocking the suprascapular nerve in the neck region. Although it has been shown in a cadaver study that the phrenic nerve can be stained after anterior suprascapular nerve block, the clinical effect is not fully known.

The effect of continuous local anesthetic drug administration on respiratory muscles through catheters placed in the peripheral nerve is another matter of concern. The method that will not affect the phrenic nerve at all and at the same time provide an effective analgesia is still under investigation.

The aim of our study is to show that the anterior suprascapular block applied with ultra-low volume (5ml) in shoulder arthroscopy operations is at least as effective as the interscalene block and does not cause diaphragm paralysis. One of the questions that our research aims to answer is how the continuous application of local anesthetic drugs affects the diaphragm muscle with the insertion of catheters in both regions.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old
* American Society of Anesthesiology (ASA) score of 1-3
* Scheduled for elective surgery.

Exclusion Criteria:

* Patients with a condition that prevents peripheral nerve block
* Coagulopathies
* Chronic opioid use
* Stroke
* Polyneuropathy
* Cognitive dysfunction
* Communication difficulties
* Allergies to drugs used
Belun Ring Platform With an Improved Algorithm for OSA Assessment

OSA is commonly diagnosed with either attended in-lab polysomnography (PSG) or unattended home sleep apnea testing (HSAT). The BLS-100 (Belun Technology Company Limited, Hong Kong) is a novel neural network-based HSAT platform consists of a ring shape pulse oximeter sensor, a cradle, and an improved proprietary analytic algorithm. This study investigates the hypothesis that the BLS-100 is a reasonable HSAT device for OSA assessment.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form.
* Age 18-80
* Clinically assessed and suspicious for OSA

Exclusion Criteria:

* Full night PAP titration study
* On home O2, noninvasive ventilator, diaphragmatic pacing, or any form of nerve stimulator
* Having atrial fibrillation-flutter, pacemaker/defibrillator, LVEF \< 55%, left ventricular assist device (LVAD), or status post cardiac transplantation
* Patients taking narcotics
* Recent hospitalization or recent surgery in the past 30 days
* Unstable cardiopulmonary status on the night of the study judged to be unsafe for sleep study by the sleep tech and/or the on-call sleep physician

An individual who meets the above criteria but fails to have at least 4 hours of technically valid sleep based on BLS-100 in a diagnostic study or at least 3 hours of technically valid sleep during the diagnostic portion of a split night study will be excluded from statistical analyses.