cyrilzakka/clinical-trials huggingface dataset:
Rasburicase for the Treatment/Prevention of Hyperuricemia in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma

The primary objective was to evaluate the efficacy of rasburicase in terms of prevention and treatment of hyperuricemia related to Tumor Lysis Syndrome (TLS) in 2 populations of adult patients, previously treated or not with urate oxidase, with relapsing aggressive non-Hodgkin's lymphoma (NHL) and at risk of TLS, presenting with hyperuricemia and/or bulky disease at diagnostic of relapse.

The secondary objectives were to :

* evaluate the efficacy of rasburicase in terms of renal protection,
* evaluate the safety of rasburicase in the two cohorts of patients,
* correlate efficacy and safety results with antibodies generation/level.


Eligibility Criteria:
Patients with histologically proven aggressive Non Hodgkin's Lymphoma
Long-Term Follow-up Study

This is an observational, non-interventional, LTFS of investigational Caribou therapies in patients who have participated in a parent study: a prior Caribou-sponsored clinical study, special access program, or an IIT. The objective is to evaluate the long-term safety, through 15 years post infusion, in patients who received IPs in a Caribou-sponsored clinical study, special access program or IIT.

This is an observational, non-interventional, LTFS of investigational Caribou therapies in patients who have participated in a parent study: a prior Caribou-sponsored clinical study, special access program, or an IIT. The objective is to evaluate the long-term safety, through 15 years post infusion, in patients who received IPs in a Caribou-sponsored clinical study, special access program or IIT.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent (by patient or legal representative) obtained prior to study-specific activities/enrollment
* Completed a Caribou-sponsored study or was administered Caribou IP under a special access program or as part of an IIT
* Use of an effective method of birth control by women of childbearing potential and their partners and men with partners of childbearing potential (partners must also use an effective birth control method) through 12 months post IP infusion.

Exclusion Criteria:

* None
Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase II

The overall aim of this research is to develop a non-invasive approach to evaluate the production of 3-methylhistidine (3MH)in cancer patients, as a potential means of determining which patients are at high risk for future development of cancer induced skeletal muscle atrophy.

Rationale: The approach is based on the hypothesis that after an oral dose of deuterated 3-methylhistidine (D-3MH), the slope of the terminal portion of the decay curve (\> 12 hours post-dosing) for the tracer/tracee (D-3MH/3MH) in the free 3MH pool is proportional to the rate constant for myofibrillar protein degradation and can be determined from spot urine samples.

The long-term objective of this research is to develop a non-invasive approach for assessment of de novo 3MH production in cancer patients early in the course of the disease as a way of assessing which patients are at high risk for future development of skeletal muscle atrophy. The approach is based on: 1) the known increase in de novo production of 3-methylhistidine (3MH) from muscle protein breakdown in said patients as a consequence of their unique disease-host interactions, and 2) earlier demonstration that de novo 3MH production can be measured in vivo using isotope dilution.

During this Phase-II project, we propose to conduct a statistically powerful prospective investigation to demonstrate that measurement of the slope of the terminal decay curve (rate constant) with our approach in newly diagnosed cancer patients predicts future development of muscle wasting. We expect the outcome of the combined Phase-I and Phase-II research to lead to the early identification of elevated muscle catabolism in at-risk patients so that medical intervention can prevent future muscle atrophy.

Eligibility Criteria:
Inclusion Criteria:

* (1) histological or cytological evidence of NSCLC without curative options;
* (2) over 18 years of age;
* (3) patient reported weight loss of ≤5% of usual body weight in the last 6 months;
* (4) life expectancy of greater than 6 months based on the judgement of treating physician;
* (5) serum creatinine ≤1.5 times the upper limit of normal; and
* (6) willing and able to give informed consent.

Exclusion Criteria:

* 1) malabsorption, intractable vomiting or gastrointestinal obstruction
* 2) congestive heart failure
* 3) edema or ascites
* 4) liver function test results that will preclude administration of prescribed therapy
* 5) pregnant, nursing, or, if of child-bearing age, unwilling to use contraceptives
Responses to Message Source and Presentation Using Psychophysiology

The goal of this clinical trial is to use psychophysiological methods to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-24
* Fluent in English
* Either vaping in the past 30 days or not having vaped in the past 30 days but susceptible to vaping
* Self-reported abstinence of combusted tobacco or marijuana at time of visit

Exclusion Criteria:

* Ages below 18 or above 24
* Not fluent in English
* Not confirmed self-reported abstinence of combusted tobacco or marijuana at time of visit
A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

The primary purpose of the study is to evaluate the efficacy of brensocatib at 10 and 40 milligrams (mg) once daily (QD) compared with placebo in improving clinical symptoms of CRSsNP.


Eligibility Criteria:
Inclusion Criteria:

* Participants who have at least a 12-week history before Screening Visit of CRSsNP and confirmed by endoscopy at Visit 1 (Screening).
* Participants must have a NCS of ≥2 at Visit 1 (Screening Visit) and Visit 2 (Baseline; average score in the week prior to randomization).
* Participants must have sTSS (nasal congestion \[NC\], anterior/posterior rhinorrhea, facial pain/pressure) ≥5 at Visit 1 (Screening) and at Visit 2 (Baseline; average score in the week prior to randomization).
* Participants who have at least 1 of the 3 following features:

  1. Previous sinonasal surgery for CRS, including but not limited to fenestrated endoscopic sinus surgery and balloon sinuplasty.
  2. Received medical treatment with systemic corticosteroids (SCS) to treat symptoms of CRS as defined by any dose and duration within 1 year of Screening Visit or intolerance/contraindication to SCS.
  3. Received a course of antibiotics to treat symptoms of CRS within 1 year before the Screening Visit.
* Participants who have a blood eosinophil count ≤750 cells/microliter (μL) at Visit 1 (Screening).
* Participants who have bilateral inflammation of paranasal sinuses in the CT scan performed during Screening and bilateral ethmoid and/or maxillary opacification before randomization as confirmed by the central reader.
* Participants who have a SNOT-22 score of ≥20 at Visit 1 (Screening) and Visit 2 (Baseline).
* Participants who have received a stable daily dose regimen of MFNS for at least 4 weeks before Visit 2 (Baseline).

Exclusion Criteria:

* Diagnosis of unilateral or bilateral chronic rhinosinusitis with nasal polyps (CRSwNP).
* Clinical diagnosis of cystic fibrosis (CF) or primary ciliary dyskinesia.
* Scheduled sinus surgery at any time during the study.
* Participants who have had nasal surgery within 4 weeks before Visit 1 (Screening) and during the Screening Period.
* Significant oral maxillofacial structural abnormalities or severe septal deviation.
* Participants with radiological suspicion or confirmed invasive fungal rhinosinusitis, odontogenic sinusitis, osteomas, or nasal tumors.
* Participants with acute change in symptoms consistent with acute rhinosinusitis.
* Participants with seasonal allergic rhinitis whose symptoms coincide with the treatment period of the study.
* Participants with moderate to severe atopic dermatitis requiring treatment with high potency topical steroids or topical calcineurin inhibitors or biologics.
* Clinical diagnosis of Papillon-Lefèvre syndrome.

Note: Other inclusion/exclusion criteria may apply.
Dutch Cholecystitis Snapshot Study

Background: Cholecystitis is treated by in various types of hospitals by different specialists, and treatment strategy is influenced by logistical and medical reasons and personal preference. This may significantly impact hospital stay and other outcomes.

Purpose: To determine the variation in treatment of cholecystitis in the Netherlands and its impact on outcome.

Methods: Nation-wide cohort study of all patients diagnosed and treated for cholecystitis during a 6 month period. The primary outcome will be the proportion of patients with an acute cholecystitis in which the guideline is followed. This group will be compared to those in which the guideline is not followed, focussing on total hospital stay and complications. Secondary aims are to determine: factors related to guideline compliance; the best method of cystic duct closure; the best treatment strategy for a \>7-day existing cholecystitis; factors predictive for concomitant common bile duct stones; strategies following gallbladder drainage. Multivariable analysis and propensity score matching will be used when appropriate for the etiological study aims. The TRIPOD guideline for prediction modelling will be used for the predictive study aims. Hospitals will receive their own results, set out against the national average and best practices, thereafter subsequent changes in hospital practice will be recorded.

Conclusion: This study will determine the variation in treatment of cholecystitis in the Netherlands and its impact on clinical outcome. Its results will serve as an important incentive to create optimal, uniform cholecystitis treatment in the Netherlands.


Eligibility Criteria:
All patients \>18 years with a calculous cholecystitis as primary reason for their hospital admittance. Location of diagnosis may the emergency department, the ward during admittance for diagnostics, or during diagnostic laparoscopy. Cholecystitis is defined according to the TG18 diagnostic criteria for a definitive diagnosis of cholecystitis: A. Local signs of inflammation (Murphy's sign and or RUQ mass/pain/tenderness) + B. Systemic signs of inflammation (Fever, elevated CRP and/or elevated WBC count) + C. Imaging findings characteristic of acute cholecystitis. Patients with a suspected diagnosis (one item in A + one item in B + C), of which the diagnosis is confirmed by peroperative findings, are also included. Patients will be identified by a local study investigator, e.g. a surgeon or surgeon in training.
Drug to Drug Interaction Study With Ipragliflozin and Furosemide

A study to investigate if there are any pharmacodynamic and pharmacokinetic interactions between furosemide and ipragliflozin (ASP1941) in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) more than or equal to 18.5 and less than 30.0 kg/m2

Exclusion Criteria:

* Any of the liver function tests above the upper limit of normal
* Abnormal pulse and/or blood pressure measurements at the pre-study visit as follows: Pulse \<40 or \>90 bpm; mean systolic blood pressure \>140 mmHg; mean diastolic blood pressure \>90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically)
* A QTc interval of \>430 ms (males) or \> 450 ms (females) consistently after duplicate measurements, a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS)
A Study to Evaluate the Effect of Oral Paliperidone Extended-Release and Oral Risperidone Immediate-Release on Cognitive Function in Clinically Stable Patients With Schizophrenia

The purpose of this study is to compare the effect of oral paliperidone extended-release and oral risperidone immediate-release on cognitive function, especially the category fluency of Cognitive Abilities Screening Instrument, Chinese version (CASI C-2.0), in patients with an established diagnosis of schizophrenia.

This is a 28-week, randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), active-controlled (patients are assigned to either a recognized effective treatment or the study medication) comparative study. All patients will enter a run-in period to receive a stable therapeutic dose of oral risperidone immediate-release for at least 4 weeks. After the 4-week run-in period, patients will be randomly assigned to either remain on oral risperidone immediate-release (IR) or to receive a therapeutic dose of oral paliperidone extended-release (ER) and patients will be prospectively followed for a 24-week treatment phase. The treatment phase is composed of a 4-week flexible dose period followed by a 20-week stable dose period. During the 4-week flexible dose period, the dose of paliperidone ER or risperidone IR may be increased or decreased for each patient if clinically indicated (eg, significant side effects emerge or there is evidence of a lack of efficacy). At the end of 4-week flexible dose period, the final dose should be maintained for the 20-week fixed-dose period. Efficacy and safety will be assessed at baseline (Week 0) and Weeks 4, 12, and 24.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with schizophrenia
* Cognitive abilities screening instrument C-2.0 total score between 50 and 85 (inclusive) at baseline
* Baseline positive and negative syndrome scale score between 60 and 85 (inclusive)
* Clinical global impression-severity change less than or equal to 1 in the month prior to randomization
* Patients on a stable therapeutic dose of oral risperidone IR (between 3-6 mg/day) for at least 4 weeks prior to randomization

Exclusion Criteria:

* Treatment refractory patients, defined as failure of more than or equal to 2 adequate trials of second generation antipsychotic treatment for schizophrenia
* History of neuroleptic malignant syndrome
* Allergy or hypersensitivity to risperidone or paliperidone, or to any of the excipients of oral risperidone IR or paliperidone ER tablets
* Participants who have taken paliperidone ER in the past
* Participants who have been treated with clozapine or any long-acting injectable (depot) antipsychotic within 3 months before randomization
Umbilical Cord Blood Mononuclear Cell Gel in the Treatment of Refractory Diabetic Foot Ulcer

Umbilical cord blood mononuclear cells (MNC) may improve the wound repair ability. This study aims to investigate the role of MNC in refractory diabetic foot ulcer by comparing the combination of PRP and MNC with PRP alone.

The difficulty in the healing of diabetic foot is related to the loss of local repair microenvironment. The platelet rich plasma (PRP) can improve the repair ability, however, the requirement for wound bed preparation is strict, or treatment failure may occur. Umbilical cord blood mononuclear cells (MNC) may provide a better repair environment through paracrine action. This study aims to investigate the role of MNC in refractory diabetic foot ulcer by comparing the combination of PRP and MNC with PRP alone.

Eligibility Criteria:
Inclusion Criteria:

1. The age of the patients is 18-80 years old;
2. Diabetic foot is diagnosed and Wagner grade is above Ⅱ;
3. The duration of ulcer is 2 months or more, with no healing trend for 2 weeks or more.
4. Fasting blood glucose ≤ 9mmol / L, 2 hours postprandial blood glucose ≤ 13mmol / L;
5. The skin oxygen partial pressure around the wound is more than 20mmHg;
6. Sign written informed consent.

Exclusion Criteria:

1. Acute spreading infection of the wound, e.g. massive exudation, redness, swelling, heat, pain.
2. Acute myocardial infarction, heart failure, hepatitis;
3. Active bleeding or hematoma in the wound;
4. Serum albumin \<25g/L;
5. Hemoglobin \<80g/L;
6. Platelets \<50×109/L;
7. Poor cooperate or compliance;The patient cannot cooperate or is.
8. Mentally disabled.
Retrospective Analysis of Pulmonary Arterial Hypertension (PAH) and Related Complications in Juvenile Idiopathic Arthritis (JIA) Participants Treated With Biologic and Non-biologic Disease-modifying Anti-rheumatic Drugs (DMARDs)

This study is designed to analyze the frequency and incidence rate of pulmonary complications in JIA participants who received biological DMARDs and non-biologic DMARDs. The participants having evidence of of a prescription or administration of one of the biologic or non-biologic DMARDs will be included in five different treatment groups. Data from the Thomson Reuters MarketScan® Commercial Claims and Medicare Supplemental Databases will be used to estimate the incidence rate of pulmonary complications.


Eligibility Criteria:
Inclusion Criteria:

* Participants with less than (\<) 18 years of age at index
* Continuously enrolled for greater than (\>) 6 months prior to index (baseline period)
* One diagnosis of JIA (714.3) on a non-diagnostic claim either during the baseline period (the complete participant record prior to the episode index will be defined as the episode baseline period) or within the first 30 days following the index date
* Had both medical and pharmacy benefit plus complete data availability during both baseline and follow-up periods

Exclusion Criteria:

* For biologic DMARD cohorts, prior use of any qualifying biologic belonging to the biologic DMARD of interest (using all available claims history)
* For non-biologic DMARD cohort, prior use of any non-biologic DMARD or biologic DMARD
* Any record of rituximab use in complete participant record
* A prior safety event during the baseline period
Fat Quality and Postprandial Inflammation

This aim of this randomized controlled postprandial study is to compare the effects of four different far sources (butter, coconut, corn oil and flax seed oil) on postprandial inflammation and metabolic response.

The main questions it aims to answer are:

1. What is the impact of different dietary sources of saturated and polyunsaturated fatty acids on postprandial inflammation?
2. Is the impact of different dietary sources of saturated and polyunsaturated fatty acids on postprandial inflammation mediated by glucose or blood lipids?
3. Can postprandial inflammatory or metabolic response be predicted by individual factors at baseline?

Participants will consume four meals, identical except for the fat source, in random order and sampled for blood and urine for up to 6 hours.

A randomized crossover single meal study will be conducted, comparing four isocaloric meals. The study will be carried out at two sites; one study center is located in Gothenburg, Sweden (Department of Internal Medicine and Clinical Nutrition at the University of Gothenburg) and one study center in Oslo, Norway (Department of Nutrition, University of Oslo).

A total of 20 healthy adults will be recruited and consume four meals, identical except for the fat source, in random order and sampled for blood and urine for up to 6 hours after. Each of the four meals will be separated by a 1 month washout. Subjects will be asked to abstain from rigorous physical activity, alcohol and high-fat foods the day prior to their test meal days.

Four isocaloric high-fat meals with different fatty acid profiles will be compared:

1. butter
2. coconut oil
3. corn oil
4. flax seed oil

At test meal days, study outcomes will be assessed at baseline (0h, fasting, pre meal), 30 min, 1h, 2h, 4h and at 6h (endpoint). At these timepoints, blood pressure will be measured and blood glucose sampled through capillary blood. At baseline, 2h, 4h and 6h, blood will be drawn by venipuncture. Urine will be collected when the participants need to void.

Blood will be collected and handled according to a standardized protocol to prevent any degradation, before stored in -80°C until analysis. At baseline and endpoint, peripheral blood mononuclear cells from blood samples will be isolated using cell preparation tubes and stored at -80 °C until RNA isolation. Lipids, lipoprotein profile and inflammation markers (e.g. cytokines, chemokines, endothelial factors) will be analyzed in samples from 0, 2, 4 and 6 hours.

Differences between meals in the outcomes will be compared using area under the curve and mixed models effect.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>18.5
* Willingness to eat study meals

Exclusion Criteria:

* Diabetes
* Cardiovascular disease
* Cancer
* Dyslipidemia
* Anemia (Hb \<100)
* Habitual intake of anti-inflammatory drugs
* Recent weight change (\>±5%)
* Pregnancy, lactation
* Current smoking
Effectiveness of Scapular Exercises Compared to Conventional Treatment in Shoulder Pain

The contribution of the scapula to shoulder joint movement is great. The contribution of the scapula bone is more prominent, especially in overhead activities. Therefore, the position and movement of the scapula are generally examined in people with shoulder disease. Scapula-focused exercises are used in patients with shoulder problems. However, some studies focused on the effectiveness of scapula-focused exercises on shoulder problems. Thes studies fundings are controversial. Scapular dyskinesis has not been evaluated in these studies. No study has set the condition of having scapular dyskinesis as an inclusion criterion. Scapular-focused exercises are expected to have a greater effect especially on patients with scapular dyskinesis. Therefore, the aim of this study is to examine the effectiveness of scapula-focused exercises on patients with shoulder pain and obvious scapular dyskinesis.


Eligibility Criteria:
Inclusion Criteria:

* Having shoulder pain for at least 1 month
* Having obvious scapular dyskinesia
* Having a shoulder ROM (range of motion) at least 120º
* Being 18 years of age or older

Exclusion Criteria:

* Having received any shoulder treatment in the last 6 months
* Having an acromioclavicular joint problem
* Having a diagnosis of frozen shoulder
* Having a fracture in the shoulder area
* Having a major rotator cuff muscle tear
* Having a diagnosis of calcific rotator cuff tendinopathy
* Having a neurological or rheumatological disease
Deep Learning With MRI-based Multimodal-data Fusion Enhanced Postoperative Risk Stratification of Breast Cancer

Breast cancer poses a significant global health challenge, especially among women, with high rates of recurrence and distant spread despite early interventions. The timely identification of metastasis risk and accurate prediction of treatment strategies are critical for improving prognosis. However, the complex heterogeneity of breast tumors presents challenges in precise prognosis prediction. Therefore, the development of innovative methods for tumor segmentation and prognosis assessment is essential.

The research conducted is a multicenter study that enrolled 1,199 non-metastatic breast cancer patients from four independent centers. Our study leverages the advancements in artificial intelligence (AI) to address this challenge. This study is the first successful application of MRI-based multimodal prediction system to precisely identify the risk of postoperative recurrence in breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed stage I-III invasive BC
* Age ≥ 18 years
* The patient having undergone surgery
* The existence of MRI scans

Exclusion Criteria:

* Lacked pathological results
* Had other, simultaneous malignancies
* Had MR imaging issues were excluded