cyrilzakka/clinical-trials huggingface dataset:
Observational Analysis of the Cause of Leaks When Bowel is Cut and Reconnected

The purpose of this study is to identify the cause of leaks that sometimes occur after a section of the bowel is removed and reconnected. Certain staplers from the operating room will be collected and sent to a third party (ECRI Institute) to be examined for defects. The patient's charts will be analyzed for medical issues that may contribute to leaks after surgery.

The objective of this study is to identify peri-operative factors that contribute to leaks after a portion of the bowel has been cut and reconnected. Most specifically, the role of staplers in this reconnection of the bowels will be evaluated. The research will take place at Icahn School of Medicine where there is an extremely high volume of operations involving small bowel and large bowel being cut and reconnected. Patients will be recruited based on inclusion and exclusion criteria and 500 subjects are expected to be enrolled in the study. The surgery will be performed in a standard fashion as indicated by diagnosis, location of disease, patient condition, and surgeon preference. No changes to the surgical procedure will be mandated by the research protocol. This is purely an observational study with no changes to the standard of care. The patients will be followed throughout the course of the their hospital stay for the scheduled surgery up to one week and one month after the procedure to gather laboratory data and any complications incurred due to the surgery. No patient specimen will be stored. The staplers used in the procedure will be collected, stored in sterile plastic container, information about the staplers will be recorded, and then discarded after 30 days in the usual manner that the operating room staff employs to discard the staplers. Subjects lost to follow-up after the procedure will be withdrawn from the study.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be scheduled for non-emergent small or large bowel surgery and reconnection of bowel at Icahn School of Medicine at Mount Sinai
* Subjects must be able and willing to provide informed consent
* Subjects must be 18 years or above OR 15-17 with permission of one parent
* English and Spanish speaking patients will be included in this study

Exclusion Criteria:

* Subject who are less than 15 years of age
* Subject who are scheduled for emergent surgery, precluding the capacity to give informed consent
* Subjects who are diagnosed with obstructed or perforated colon cancer
A Study on the Use of Tanakan® for Recovery of Neurological Impairment Following Ischaemic Stroke

The purpose of this study is to evaluate the effectiveness of Tanakan® 240mg in association with Acetylsalicylic acid (325mg/day) in the recovery of neurological impairment following ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Patient having had a single infarct in the carotid artery territory 3 to 8 days before inclusion
* Patient with a moderately severe or severe disability (Modified Rankin Score 4 or 5)
* Patient having a Quick's Test (for INR) and APPT (activated partial prothrombin time) test in the normal values of the laboratory

Exclusion Criteria:

* Patients having had an ischemic stroke (CT confirmed) less than 3 days and more than 8 days prior
* Patient with known pre-existent cerebral infarction
* Infarct damaged area bigger than 1/3 hemisphere
* Patient having a score below the cut-off point at Frenchay Aphasia Short Test
Prevention of Post-ERCP Pancreatitis by Indomethacin Vs Diclofenac

Post-ERCP pancreatitis (PEP) is the most common complication after ERCP, which was associated with occasional mortality, prolonged hospital days and increased health costs. Some studies investigated the effectiveness of different Nonsteroidal antiinflammatory drugs (NSAIDs) for prevent PEP. However, several high-quality RCTs and meta-analyses consistently demonstrated only100mg rectal indomethacin or diclofenac significantly reduced PEP incidence compared with placebos. Thus, European Society of Gastrointestinal Endoscopy, American Society for Gastrointestinal Endoscopy and Japanese Society of Hepato-Biliary-Pancreatic surgery guidelines recommended rountine administration of 100mg rectal indomethacin or diclofenac in unselected patients who underwent ERCP.

Up to date, the mechanisms of NSAIDs in preventing pancreatitis were not fully elucidated. Diclofenac and Indomethacin showed similar inhibitory effects in phospholipase A2 and cyclooxygenase pathways. And the peak concentration of diclofenac and indomethacin both occurs between 30 and 90 min after rectal administration. However, diclofenac may be a stronger inhibitor of other pancreatitis-related imflammatory siginals (e.g. nuclear factor kappa-B) than indomethacin. Recently, several meta-analyses found 100mg rectal diclofenac to be more efficacious than 100mg rectal indomethacin. Despite these data, there is no conclusive evidence to prove that rectal diclofenac could provide incremental benefits over indomethacin from high-quality randomized, controlled trials. Therefore, the investigators conducted a multicenter, double-blind, randomized, controlled clinical trial to evaluate the efficacy of rectal diclofenac versus indomethacin for the prevention of post-ERCP pancreatitis in average-risk patients.


Eligibility Criteria:
Inclusion Criteria:

* 18-90 years old patients planned to undergo ERCP

Exclusion Criteria:

* Allergy to NSAIDs
* The administration of NSAIDs within 7 days
* Not suitable for NSAIDs administration (gastrointestinal hemorrhage within 4 weeks, renal dysfunction \[Cr \>1.4mg/dl=120umol/l\]; presence of coagulopathy before the procedure)
* Previous biliary sphincterotomy and papillary large balloon dilation
* Acute pancreatitis within 3 days before ERCP
* Hemodynamical instability
* Pregnancy or lactation
* Unable to give informed consent
Evaluating a Novel Mobile App for Social Cognition in Psychosis

To develop, and then evaluate a mobile phone app to deliver therapy homework activities between group sessions (social cognition intervention) in individuals with psychosis. The investigators are interested in whether offering homework via an app is a) feasible, and b) acceptable.

The investigators will also assess whether there is an initial indication that offering homework via the app improves outcomes following the group therapy.

This study is a pilot, feasibility trial of a clinical intervention.

The investigators will initially pilot the app with three clinical participants, who will be asked to use the app for a period of three days and provide feedback as to whether there are any difficulties with usability, glitches, display, etc.

Two therapy groups will then be run consecutively. The therapy delivered will be a modified version of Group Training for Social Cognition in Psychosis (GRASP). Both groups will receive their homework tasks delivered via an app. Participants will undergo an assessment before and after the therapy, and a follow up interview as detailed in the measures section below. Primary objective: To evaluate a mobile app to deliver therapy homework between sessions of a social cognition therapy group for individuals with psychosis. The investigators are interested in whether offering homework via an app is a) feasible, and b) acceptable.

Secondary objective: To assess whether there is an initial indication that our intervention improves social cognition skills.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis on the psychosis spectrum (using either DSM 5, DSM-IV, or ICD-10 \[F20-F29\])
* Age 18-65 years
* Good command of the English language
* Premorbid IQ of over 70
* Owns a smartphone or willing to use a study smartphone for the required period
* Likely to benefit from social cognition intervention as assessed by clinical team \[for intervention part\].

Exclusion Criteria:

Lacks capacity to give informed consent to participate in research

* Poses significant risk to self or others
* Inability to understand verbal or written English (i.e. inability to understand information sheet or requires an interpreter).
* High levels of psychotic symptoms which precludes meaningful participation
* Unsuitable to attend groups (group-therapy part only)
A Study Using Healthy Volunteers Comparing Belatacept Which Has Been Manufactured By 2 Different Processes

This study compares the movement of Belatacept drug products, whose active pharmaceutical ingredient has been manufactured by 2 different processes, into, through and out of the body (pharmacokinetics/PK) of healthy volunteers. Eligible participants will be randomly assigned to one of two groups, and will receive a single dose of a belatacept product once during a 4-day stay at a study site.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form.
* Healthy participants, determined by medical history, physical examination, electrocardiograms (ECGs) and clinical laboratory tests.
* Weight between 60.0 to 100.0 kg, inclusive.
* Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive.
* Women of childbearing potential (WOCBP) must have a negative pregnancy test within 24 hours prior to the start of study treatment.
* WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment and for a total of 80 days after treatment ends.
* Women must not be breastfeeding.
* Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment and for a total of 140 days after treatment ends. In addition, male participants must not donate sperm during this time.

Exclusion Criteria:

* Participants with active tuberculosis (TB) requiring treatment; a history of active or latent TB without documented adequate therapy; or with current clinical, radiographic or laboratory evidence fo active or latent TB.
* History of shingles (herpes zoster).
* Personal or strong family history of cancer.
* Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, e-cigarettes, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to study treatment administration.
* Any known or suspected autoimmune disorder.

Other protocol defined inclusion/exclusion criteria could apply.
Dose-confirmatory Bridging Study in Total Knee Replacement

The objective of this dose-confirmatory bridging study is to investigate the safety and efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous thromboembolism (VTE) in Japanese patients undergoing elective total knee replacement (TKR) and to confirm the extrapolability of global data to Japanese patients by comparing with data from overseas phase III study (RECORD 3 - Study 11356) and phase II studies.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 20 years or above
* Patients undergoing elective TKR (the first replacement of the applicable knee joint)
* Patients' written informed consent to participation after receiving detailed verbal and written information on any study specific procedures in advance

Exclusion Criteria:

* Planned, staged major orthopedic surgery within 3 months prior to elective TKR or during this study
* History of clinically significant active bleeding (e.g. intracranial bleeding, gastrointestinal bleeding\*), or high bleeding risk

  \*: within 3 months prior to elective TKR for gastrointestinal bleeding
* Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
* Severe impaired renal function (CLCR calculated by Cockcroft-Gault formula: \<30 mL/min)
* Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)
* Ongoing anticoagulant therapy (e.g. warfarin, heparins and Factor Xa inhibitors other than study medication) that cannot be stopped (in the opinion of the investigator/sub investigator)
* Subjects for whom epidural catheters are expected to be left in for longer than 18 hours post-operatively
* Planned intermittent pneumatic compression during treatment period.
Use of Honey for Pressure Ulcers in Critically Ill Children

The enrolled children would be randomized to one of the groups 'study group' or 'Honey dressing group' or 'Group I' (honey dressing containing Active Leptospermum Honey also known as Manuka honey would be used), changed every alternate day for a maximum period of upto 8 weeks (in cases of stage IV ulcers) or till healthy granulation tissue appears, whichever is earlier and 'control group' or 'Standard treatment group ' or 'Group 2' (paraffin gauze is applied after application of povidone iodine). Randomization will be performed as per protocol. Primary outcome will be reduction in time to healing of any stage of pressure ulcer and secondary outcomes will be treatment failure and new onset infection of ulcer.

Children admitted to the PICU would be eligible for inclusion. The interventions will be initiated within the hospital itself. All children will be managed as per standard treatment protocols of the unit for various disease conditions. The enrolled children would be randomized to one of the groups 'study group' or 'Honey dressing group' or 'Group I' (honey dressing containing Active Leptospermum Honey also known as Manuka honey would be used), changed every alternate day for a maximum period of upto 8 weeks (in cases of stage IV ulcers) or till healthy granulation tissue appears, whichever is earlier and 'control group' or 'Standard treatment group ' or 'Group 2' (paraffin gauze is applied after application of povidone iodine). Randomization will be performed as per protocol. Primary outcome will be reduction in time to healing of any stage of pressure ulcer and secondary outcomes will be treatment failure rate and new onset infection of ulcer. The investigators ICU is a fully equipped 8 bedded ICU with all ventilated beds. There are 2 full time consultants, residents and staff with nurse patient ratio of 1:1 to 1:2. Therefore, the investigators are well equipped to treat critically ill children. There will be an in-built mechanism of assuring quality of processes at different steps.

Eligibility Criteria:
Inclusion Criteria:

* All children aged \<17 years admitted to the ICU and developing any stage of pressure ulcer due to mechanical pressure or device related pressure during the PICU stay will be eligible for the study

Exclusion Criteria:

Children with pressure ulcers and

* Who are on more than 1 inotrope would be excluded.
* Having signs of acute wound infection,
* Having wounds with \> 5 cm diameter,
* Having allergy to honey and not willing to give consent would be excluded.
Prevention of Neck Pain in Adults With a Back School-Based Intervention.

The study consists of a theoretical and practical intervention based on the Back School. This intervention will be carried out over 8 weeks with a frequency of two sessions per week, for a total of 16 sessions of 45 minutes duration. Of all the sessions, 14 had a practical focus (strength and stretching exercises) and the other two had a theoretical focus (self-management techniques and pain neuroscience education).

The clinical practice guidelines highlight the importance of neck pain prevention through exercise an education. There are previous studies of the effects of theoretical and practical programmes based on back school on the lumbar region but not on the cervical region.Therefore, the main aim of this innovative study is to to investigate the effects of a Back School based intervention on the prevention of neck pain and as secondary objectives to investigate the effects on neck flexor and extensor strength as well as scapular stability. The hypothesis is that this BS-based intervention would have positive effects on neck pain prevention, neck strength and scapular stability.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 - 65 years old.
* Not have had neck pain in the last 6 months.

Exclusion Criteria:

* Previous neck or shoulder surgery, cervical radiculopathy/myelopathy, history of the whiplash injury.
* Taking any medication or having any musculoskeletal, rheumatic, metabolic, cardiological, cognitive disorder or neurological disorder.
* Missing more than two Back School sessions.
* Not being able to attend the measurement sessions.
Use of Analgesic Drugs in Renal Colic in Emergency Room

A prospective non-interventional study on the use of analgesic drugs in renal colic in emergency rooms


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old
* Suspicion of renal colic (pain in a lumbar pit radiating to the external genital organs, rapidly progressive onset, non-febrile)

Exclusion Criteria:

* Shock
* Glasgow score less than 15
* Oxygen saturation less than 93% in ambient air
* Signs of intracranial hypertension (headache associated with vomiting)
* Suspicion of pneumothorax
* History of emphysema or chronic obstructive pulmonary disease
* Diving accident or suspicion of gas embolism
* Trauma of the face of interest in the area of application of the mask
* Abdominal gas distension
* Contraindication in Nonsteroidal anti-inflammatory drugs
* Pregnancy
SerUM Markers in MERkel Cell Carcinoma Patients: a Longitudinal moniTorIng Study for optiMization of European Guidelines

Merkel cell carcinoma (MCC) is a rare aggressive skin carcinoma. Approximately 80% of MCC are related to the Merkel Cell Polyomavirus (MCPyV). Although rates of relapse are high, the follow-up strategy lacks consensus. Patients are usually assessed clinically every 3 to 6 months for the first 2-3 years, and every 6 to 12 months thereafter. In the European guidelines, patients with early stages are monitored with clinical examination and ultrasonography of lymph nodes, while whole-body imaging is optional in patients with stage III disease, on a yearly basis for 5 years. Such strategy may prevent the diagnosis of infra-clinical recurrences, whereas patients could still be treated with surgery or radiation therapy. Until 2017, patients with advanced disease were treated with chemotherapies, with no long-term benefit. Immunotherapies with PD-1/PD-L1 inhibitors currently allow durable responses in 50% of such patients. This major change in the management of MCC patients argues for a follow-up strategy that would allow early diagnosis of infra-clinical metastases, when tumoral burden is still low. Given that all patients cannot be monitored by systematic regular imaging, additional non-invasive tools are needed. Blood-based biomarkers as a surrogate of tumor burden are advantageous as they can be repeated over time, providing guidance on when imaging is necessary. The study aims to assess two blood biomarkers, MCPyV T-Ag antibodies and cell-free miR-375, in a prospective fashion from baseline diagnosis, in a cohort of 150 European MCC patients


Eligibility Criteria:
Inclusion Criteria:

* Patients with a " de novo " diagnosis of MCC, confirmed on histological criteria (neuroendocrine morphology, CK20 staining and/or neuroendocrine and/or SATB2 staining, exclusion of differential diagnosis)
* ≥ 18 years of age
* Written informed consent obtained from the participant

Exclusion Criteria:

* Patients following any measures of legal presentation
* Pregnancy or breastfeeding
Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women

The study plans to find out whether Celebrex may be potentially useful to decrease inflammation in fat tissues and thereby lower the production of substances such as estrogens that may increase the risk of developing breast cancer and lead to a poor outcome of the disease.

This study seeks to examine how effective the celebrex may be in reducing inflammation, crown-like structures in fat tissue, the enzyme aromatase, PGE-M in the urine and estrogen in blood and urine. Volunteer subjects will be expected to stay in the hospital for about 2 weeks taking Celebrex for approximately 10 days while eating a diet similar to what they consumed before coming into the hospital for the study.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal woman defined as: 24 consecutive months without a menstrual period and currently not taking any medication known to induce amenorrhea.
* Serum estradiol \< 20 pg/mL
* Body Mass Index of 35-50
* Stable weight defined as (+/- 5 %) of body weight for at least three months
* 40-70 years of age
* Fluent in English

Exclusion Criteria:

* Known hypersensitivity to celecoxib or sulfonamides
* Known peptic ulcer disease
* Hypertension BP \> 150/90 (on 2 occasions after resting)
* Fasting blood glucose \> 165 mg/dL
* HIV positive
* Screening creatinine \> 2X upper limit of normal
* Screening LFT results \> 2x upper limit of normal
* Smokers (or stopped \< 3 months ago)
* Framingham risk score \> 15
* Evidence of active coronary disease by history and/or EKG
* Subjects who consume 25 grams of soy protein/day or more than 45 mg of isoflavones/day, for subjects who consume this amount of soy, they may stop for 14 days prior to admission
* Currently taking NSAIDS, aspirin, (if \> once a week, stopped \<30 days ago).
* Consuming \> 3 servings of fish or seafood/week
* Currently taking fish oil, omega-3 supplements or other herbal supplements that exceed GRAS (Generally Recognized as Safe) levels, (if currently taking fish oil/omega-3 supplements, there must be a 30 day washout period)
* Current use of anti-coagulants
* Currently taking any weight control medication
* Currently taking thioridazine
* Currently taking lithium
* Currently taking any estrogen/progesterone hormones including vaginal cream, e-string, or vaginal tablets
* Currently taking any medication that can alter fat stores as determined by the principal investigator
* History of Inflammatory Bowel Disease or other chronic inflammatory disorders
* History of any malignancy other than non-melanoma skin cancer in the past 5 years
* History of any bleeding disorder
* History of cardiovascular disease
* Diagnosis of asthma
* Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.
A Study of CAR-T Cells in Subjects with Autoimmune Diseases

The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in Subjects with autoimmune diseases.

This study is a single center, one-arm, open label study aimed at evaluate the safety and efficacy of CAR-T Cells to treating Subjects with Autoimmune Diseases.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female, between 18 and 65 years old;
2. Diagnosed with Autoimmune Diseases, such as Systemic Lupus Erythematosus, Systemic Sclerosis, Idiopahic Inflammatory Myopathies, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Sjögren's Syndrome, Antiphospholipid Syndrome, Immune Thrombocytopenia；
3. Good organ functions;
4. Voluntary participates this trial and can comprehend and sign ICF.

Key Exclusion Criteria:

1. Had or has active malignancy;
2. Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
3. Combined with other autoimmune disease that needs treatment;
4. Pregnant or lactating women;
5. Has other factors that deemed not suitable by investigator.