cyrilzakka/clinical-trials huggingface dataset:
First Line Therapy for High Risk Acute GVHD

The purpose of this study is to determine the efficacy and safety of combined Ruxolitinib With Corticosteroids as First Line Therapy for the Treatment of High risk aGVHD(acute graft-versus-host disease )

Acute graft-versus-host disease (aGVHD) is treated with systemic corticosteroid immunosuppression as first line therapy. Many patients with high risk aGVHD do not respond to primary therapy, high-dose systemic corticosteroids; therefore, survival for those patients remains particularly poor. Here we determine the efficacy and safety of combined Ruxolitinib With Corticosteroids as First Line Therapy for the Treatment of High risk aGVHD.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed with hematological diseases.
2. Have undergone first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies.
3. new onset of grade II\~IV aGVHD or intermediate or high risk aGVHD (based on ST2, REG3a, other experimental objects) within 100 days post-transplantation.

Exclusion Criteria:

1. recipients of second allogeneic stem cell transplant.
2. acute GVHD induced by donor lymphocyte infusion, interferon.
3. received first line aGVHD treatment before enrollment.
4. overlap GVHD syndrome.
5. pregnant or breast-feeding women.
6. absolute neutrophil count (ANC) \<0.5×10e9/L or platelet count (PLT) \< 20×10e9/L
7. Serum creatinine \> 2.0 mg/dL or creatinine clearance \< 40 mL/min measured or calculated by Cockroft-Gault equation.
8. uncontrolled infection
9. human immunodeficiency virus infection
10. active hepatitis b virus, hepatitis C virus infection and need antivirus treatment.
11. Subjects with evidence of relapsed primary disease, or subjects who have been treated for relapse after the allo-HSCT was performed, or graft rejection.
12. allergic history to Janus kinase inhibitors.
13. Severe organ dysfunction unrelated to underlying GVHD, including:

    Cholestatic disorders or unresolved veno-occlusive disease of the liver (defined as persistent bilirubin abnormalities not attributable to GVHD and ongoing organ dysfunction).

    Clinically significant or uncontrolled cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia that requires therapy.

    Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen.
14. Received Janus kinase inhibitor therapy after allo-HSCT for any indication.
15. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.
Nutrition and Chemotherapy

Patients treated for cancer nowadays have many means of information and tend to become more and more involved in their health. The interest of a therapeutic fast with detoxifying or even curative properties, with a specific indication for cancer patients treated by chemotherapy, is nowadays relayed by the media. To date, there are no studies conducted on the scope of this information in cancer patients or on the attitudes of oncologists towards this practice and possible positioning requests from patients.

We hypothesize that the choice of this practice and its modalities are rarely discussed with oncologists, although it may have deleterious repercussions on the patient's health.

We propose a research based on the principles of sociological intervention. Its objectives are a first review of the issue and the establishment of a joint working group, including patients, carers and researchers, which will propose solutions to improve the patient/carer dialogue on this issue.

Patients treated for cancer nowadays have many means of information and tend to become more and more involved in their health. The interest of a therapeutic fast with detoxifying or even curative properties, with a specific indication for cancer patients treated by chemotherapy, is nowadays relayed by the media. To date, there are no studies conducted on the scope of this information in cancer patients or on the attitudes of oncologists towards this practice and possible positioning requests from patients.

We hypothesize that the choice of this practice and its modalities are rarely discussed with oncologists, although it may have deleterious repercussions on the patient's health.

We propose a research based on the principles of sociological intervention. Its objectives are a first review of the issue and the establishment of a joint working group, including patients, carers and researchers, which will propose solutions to improve the patient/carer dialogue on this issue.

Eligibility Criteria:
Inclusion Criteria:

* Major patients, follow-up on Institut de Cancerology Lucien Neuwirth day service chemotherapy treatment
* Patient affiliated or entitled to a social security scheme
* Patient who received informed information about the study
* Patient able to read French

Patients participating in the qualitative study:

Exclusion Criteria:

* Refusal to participate, protected adult person, under guardianship or curatorship
* Person unable to understand the conduct of the study
* Person with a documented history of cognitive or psychiatric disorders
Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults

The investigators want to determine if the benefits of weight loss outweigh the potential risk in a group of older adults. The investigators will test the hypothesis that changes in diet composition alone or in conjunction with weight loss will have a significant effect on fat stores, and as a result, improve cardiometabolic risk factors and functional status in adults 65 and older.


Eligibility Criteria:
Inclusion Criteria:

* at least 65 years of age
* BMI 27 - 42 kg/m2 - at increased health risk (taking at least 1 medication for hypertension, hyperlipidemia, or type 2 diabetes)

Exclusion Criteria:

* difficulties chewing or swallowing food
* digestive diseases that may affect the ability to follow a high fiber diet
* cognitive impairment
* depression
* recent weight change (+/- 10 lbs in the last 12 months)
* poorly controlled blood pressure
* history of non-skin cancer in last 5 years
* cardiovascular disease event in past 6 months or severe pulmonary disease or renal failure
* major liver dysfunction
* current smoker or quit less than months prior
* history of prior surgical procedures for weight control or liposuction
* use of estrogen or testosterone replacement therapy
* current use of insulin or sulfonylurea agents
* current use of corticosteroids \> 5 days/month on average
* current use of medications for treatment of psychosis or manic-depressive illness
* use of weight-loss medications in previous 3 months
* dependence on others for food procurement or preparation
* ischemic changes on exercise treadmill test
Tumor Registry Pancreatic Cancer

The registry aims to collect and analyse information on the antineoplastic treatment of patients with unresectable locally advanced or metastatic pancreatic cancer, treated in palliative intention (cohort 1) and patients with localized, resectable pancreatic cancer treated in neo-adjuvant or adjuvant intention (cohort 2) in daily routine practice in Germany. The registry will follow up patients for two years. It will identify common sequences of treatments used as well as changes in the treatment of the disease. Health-related quality of life will be analysed during the course of the treatment (PanLife). Based on the available data a prognostic score will be developed.


Eligibility Criteria:
Inclusion Criteria:

* resectable or locally advanced/metastatic pancreatic cancer
* 18 years and older
* Antineoplastic treatment
* Date of consent no later than 2 weeks after start of first-line treatment

Exclusion Criteria:

* No pancreatic cancer
* Below 18 years and older
* No antineoplastic treatment
* Date of consent later than 2 weeks after start of first-line treatment
Urinary Tract Infections Caused by Extended-spectrum Beta-lactamase-producing Enterobacteria

Urinary tract infections (UTIs) are one of the most common pathologies encountered in general practice. However, with increasing bacterial resistance to antibiotics, their treatment is becoming increasingly complex. Extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-E) pose a particular challenge due to their increased resistance to many commonly used antibiotics. The aim of this thesis is to study the management of such infections by general practitioners in Bas-Rhin and to suggest possible avenues for improvement.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years old)
* Subject with an Enterobacteriaceae urinary tract infection treated in a primary care setting for urinary tract infection between June 1, 2024 and December 31, 2024
* Subject not objecting, after being informed, to the reuse of their data for the purposes of this research.
* The subject's primary care physician agreeing to participate in the study

Exclusion Criteria:

* Subject and/or their primary care physician having expressed their opposition to participating in the study
* Subject under legal protection
* Subject under guardianship or curatorship
SOon HOme Study About Preterm Infants

The goal of this randomized controlled trial without medication neither device (for procedure) is to compare the average length of hospital stay of infants weaned from the incubator at a weight greater than or equal to 1400 grams versus infants weaned at a weight greater than or equal to 1600 grams.

The main questions it aims to answer are:

* Is it possible to reduce the average hospital stay in the early weaning group compared with the standard weaning group?
* Is this procedure safe and without adverse outcomes between the two groups during the hospital stay and during the first week after discharge?

Premature or low-birth-weight infants have low thermoregulatory abilities, higher risk of hypothermia and thus require a heated environment to survive. In the Neonatal Intensive Care Unit, these infants are placed from birth in an appropriately heated and humidified incubator. When they gain thermal competence they are gradually transferred to the open crib, normally when they reach a weight of about 1600-1800 grams, although the practice varies widely among neonatal units. Recent studies have concluded that clinically stable preterm infants can be transferred to an open crib at a body weight of less than 1600 grams. The abilities to maintain a normal body temperature in an open crib, good feeding autonomy, stable cardio-respiratory function, and acceptable growth rate are the physiological skills generally required for discharge of infants from the hospital.

The study compares the average length of hospital stay of infants weaned from the incubator at a weight greater than or equal to 1400 grams versus infants weaned at a weight greater than or equal to 1600 grams, as well as the incidence of adverse outcomes between the two groups (lower growth rate, inadequate breastfeeding, thermal lability and need for the incubator, readmission to the hospital) during the ward stay and during the first week after discharge, the degree of psychological stress of the parents, and the quality of the parent-child relationship in the two different groups.

Eligibility Criteria:
Inclusion Criteria:

* Infants with birth weight less than 1400 grams in incubator who have reached a minimum weight of 1400 grams
* Stable clinical condition: normal heart rate and respiratory rate, No need for invasive respiratory assistance, no episodes of apnea, stable axillary temperature not less than 36.5°for at least 72 hours.
* No need for phototherapy
* Stable or increasing weight for at least 48 hours
* Signature by both parents of an informed consent

Exclusion Criteria:

* Severe congenital anomalies at birth
* Need for invasive respiratory support at the time of enrollment
* Ongoing phototherapy
* Major surgical pathology with need for surgery
* Failure by both parents to sign up for informed consent
Effect of Diltiazem on Pharmacokinetics of BMS-914392

The purpose of this study is to assess the effects of diltiazem on the pharmacokinetics of single-dose BMS-914392 in healthy subjects.

Protocol designed to evaluate the potential for a drug-drug interaction

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy

Exclusion Criteria:

* Current or recent (within 3 months of study drug administration) gastrointestinal disease
* Current or history of neurological diseases or psychiatric disorders and cardiovascular diseases
TAHOE: Intravitreal Dexamethasone Implant (Ozurdex) for Uveitic Macular Edema

The purpose of this study is to determine whether an intravitreal dexamethasone implant (Ozurdex, Allergan) is effective to manage macular edema secondary to non-infectious uveitis.

Uveitis accounts for more than 10% of all cases of severe vision loss in developed countries, which makes it possibly the fourth leading cause of blindness in the United States. Cystoid macular edema (CME) is the most structural complication of uveitis, resulting in visual impairment and blindness. If left untreated or undertreated over a period of years, CME may result in permanent photoreceptor damage of the macula and loss of central vision. Further, CME may persist despite adequate control of the uveitis, and therefore, adjuvant therapy to specifically treat the CME may be required.

We propose to study whether a sustained steroid delivery system (Ozurdex, Allergan) can treat uveitic macular edema. Ozurdex has been proven to be effective for non-infectious posterior uveitis; and FDA approved for posterior uveitis. The sustained delivery of the steroid and local delivery modality makes it an ideal candidate to manage macular edema in uveitis.

Eligibility Criteria:
Inclusion Criteria:

* Uveitis CME with central subfoveal thickness \> 350 microns
* non-infectious uveitis
* Visual Acuity \> 20/32

Exclusion Criteria:

* Visual Acuity worse than 20/200
* Moderate or severe glaucoma (as defined as \>2 topical ocular medications)
* Infectious uveitis
* Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infections, and fungal diseases.
* Aphakic eyes with rupture of the posterior lens capsule
* Anterior Chamber intraocular Lens and rupture of the posterior lens capsule
* Hypersensitivity to any components of the Ozurdex
Post-Extubation Assessment of Clinical Stability in ELBW Infants

This is an observational, proof-of-concept, feasibility study that aims to evaluate the feasibility of a monitoring system that integrates clinical data, high-resolution waveforms from the bedside monitor, regional oxygenation (via cerebral and splanchnic near-infrared spectroscopy), and regional ventilation (via electrical impedance tomography) from 20 extremely low birth weight infants at high-risk of reintubation.

The primary aim of this proof-of-concept study is to evaluate the feasibility and acceptance of a monitoring system that integrates clinical data and biomedical signals from multiple modalities in a cohort of extremely preterm infants at high-risk of clinical instability on non-invasive respiratory support.

Secondary aims will be to longitudinally describe peripheral oxygen saturation, cerebral oxygen saturation, splanchnic oxygen saturation and regional lung ventilation in extremely low birth weight infants with or without reintubation during the 7 days post extubation.

The application of this multimodal monitoring approach using both clinical and physiological data during the postextubation period will help by making the assessment of clinical stability more comprehensive, more objective, more accurate, more standardized, and more reflective of important end-organ function. Thus, the proposed multimodal monitoring could lead to more informed decisions about reintubation and more individualized treatment plans during this critical period, hence potentially leading to better outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight \< 1000g and gestational age \< 28+0 weeks,
* Received mechanical ventilation within the first 72h of life,
* Undergoing their first planned extubation within the first 6 weeks of life.

Exclusion Criteria:

- Congenital anomalies and congenital heart disorders.
Promoting Organizational Capacity to Implement Cancer Control Programs Among Latino Churches

This research study aims to develop an organizational-level intervention to enable communities to adopt, adapt, implement and sustain evidence-based interventions (EBIs) to address cancer disparities among Latinos. The investigators partner with faith-based organizations, since they play a highly prominent role in Latino community life. This three-phase study will: (1) improve understanding of the organizational infrastructure, skills and resources required by Latino churches to implement EBIs for cancer control, (2) develop a capacity-building intervention; and (3) test the intervention's effectiveness in a randomized trial.


Eligibility Criteria:
Inclusion Criteria:

* Parishes eligible for the Randomized trial are those that are: Roman Catholic, located in Massachusetts, offer religious services in Spanish, and have taken part in the organizational survey.

Exclusion Criteria:

* Not Roman Catholic, not located in Massachusetts, don't offer religious services in Spanish, and have not participated in the organizational survey.
Impaired HDL and Coronary Artery Disease in Anabolic Androgenic Steroid Users

Anabolic androgenic steroids (AASs) have been associated with coronary artery disease (CAD). The illicit use of these substances also leads to a remarkable decrease in high-density lipoprotein (HDL) plasma concentration, which could be a key factor in the atherosclerotic process. The investigators tested the functionality of HDL by cholesterol efflux and antioxidant capacity and its association with CAD in young men.

Twenty strength-trained AAS users (AASU) age 29±5 yr, 20 age-matched strength-trained AAS nonusers (AASNU), and 10 sedentary controls (SC) were enrolled.

HDL concentration and functionality by measuring the 14C-cholesterol efflux mediated by HDL and the ability of HDL in inhibiting LDL oxidation were evaluated.

Coronary artery was evaluated with coronary computed tomography angiography.

Eligibility Criteria:
Inclusion Criteria:

* Anabolic androgenic steroids users and Anabolic androgenic steroids nonusers groups had been involved in strength training for at least 2 years;
* Anabolic androgenic steroids users should be self-administering anabolic androgenic steroids in periodic cycles lasting from 8 to 12 weeks for at least 2 years with 2-4 cycles per year;
* All anabolic androgenic steroids users were on a cycle over the course of the study;
* Sedentary control group: sedentary men without cardiovascular disease.

Exclusion Criteria:

* Smoking;
* Alcohol consumption;
* Use of diuretics and/or antihypertensive medications;
* Liver and kidney disease
Dipraglurant (ADX48621) for the Treatment of Patients With Parkinson's Disease Receiving Levodopa-based Therapy

This study is designed to evaluate the safety and efficacy of dipraglurant in PD patients with dyskinesia (randomized 1:1 to receive active or placebo) for 12 weeks (1 week at 150 mg per day and 11 weeks at 300 mg per day). The primary efficacy assessment will be based on the Unified Dyskinesia Rating Scale (UDysRS). Patients who complete the 12-week blinded treatment period may have the option to roll into an open-label safety extension study for an additional 12-month treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson's Disease on a stable regimen of antiparkinson's medications, including a levodopa preparation administered not less than 3 times daily.
* Meet protocol-specified criteria for moderate to severe dyskinesia symptoms based on UDysRS and Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assessments.
* Meet protocol specified criteria for ON time with troublesome dyskinesia based on a standard PD home diary.

Exclusion Criteria:

* Prior surgical treatment for Parkinson's Disease (e.g., deep brain stimulation).
* Other neurological disease (including psychiatric disease and/or cognitive impairment) that, in the opinion of the investigator, would affect the patient's ability to complete study assessments.
* Other significant medical condition that may affect the safety of the patient or preclude adequate participation in the study.
* Pregnant or breast-feeding. Female patients who are of child-bearing potential must be using adequate contraceptive methods (e.g. oral contraceptive, double-barrier method, intra-uterine device, intra-muscular hormonal contraceptive), and have a negative pregnancy test at Screening.

Other protocol-defined inclusion and exclusion criteria may apply
COVID-19 SARS-CoV-2 Antibody Testing Study

SATS is a single site feasibility study to assess the practical and psychological feasibility of using rapid COVID antibody testing of blood obtained from fingertip pin-pricks.

SATS is a feasibility study conducted at a single site - King's College London and South London and Maudsley staff working at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN) at Denmark Hill, London, England. The practical and psychological feasibility of using rapid COVID antibody testing of blood obtained from fingertip pin-pricks will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* King's College Staff member
* Aged 18 years or over
* Able to freely give informed consent

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

* known to have an infectious disease including a current SARS-CoV-2 infection.
* Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the research study, or may influence the result of the research study, or the participant's ability to participate in the research study. Examples of disorders or diseases which would be excluded include:

  * Medically diagnosed bleeding disorder;
  * Medically diagnosed platelet disorder;
  * Anticoagulant medication.