cyrilzakka/clinical-trials huggingface dataset:
L-DEP/DEP Regimen and PD-1 Antibody as a Treatment for Relapse/Refractory EBV-HLH

This study aimed to investigate the efficacy and safety of L-DEP (L-Asparaginasum, liposomal doxorubicin, etoposide and methylprednisolone) together with PD-1 antibody as an treatment for relapse/refractory EBV associated hemophagocytic lymphohistiocytosis.

PD-1 antibody added to the DEP regimen （with or without asparaginases） in EBV-HLH

Eligibility Criteria:
Inclusion Criteria:

1. Meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria;patients were diagnosed with EBV associated HLH (EBV-HLH).
2. EBV-DNA in peripheral blood or EBER in tissue were positive.
3. Treated with HLH-94 no less than 2 weeks before enrollment and did not achieve at least partial response
4. The patient is expected to be unable to undergo allogeneic hematopoietic stem cell transplantation in the short term due to various reasons (physical status, economic reasons, donor reasons, etc.)
5. The expected survival time is more than 1 month.
6. Age ≤ years old, gender is not limited.
7. Serum creatinine ≤ 1.5 times normal；After infusion, fibrinogen can be corrected to ≥0.6g/L.
8. Serum human immunodeficiency virus(HIV) antigen or antibody negative； Hepatitis C virus (HCV) antibody is negative, or HCV antibody is positive, but HCV RNA is negative；HBV copies less than 1E+03 copies/ml.
9. The left ventricular ejection fraction (LVEF) was normal.
10. No uncontrollable infection.
11. Contraception for both male or female.
12. Informed consent obtained.

Exclusion Criteria:

1. Allergic to doxorubicin and/or etoposide and/or PD-1 antibody Injection
2. Severe myocardial injury, myocardial enzymes CK, CK-MB increased more than 3 times ULN (upper limit of normal)
3. Heart function above grade II (NYHA).
4. Thyroid dysfunction
5. Serious mental illness;
6. Active hemorrhage of internal organs
7. Previously received L-DEP regimen for HLH-targeted treatment, but the treatment was ineffective or relapsed
8. Accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2
9. Participate in other clinical research at the same time.
Exploratory Investigation of Data Obtained From a Sensor Connected to an Intermittent Catheter

The purpose of the investigational device in the proposed clinical investigation is to capture pressure data prior to and during voiding using a CE-marked commercially available catheter.

This clinical investigation is based on an open explorative design evaluating the sensor ability to record readable data in healthy volunteers and the extent of artifacts influencing data quality and readability in healthy volunteers.

Overall:

* Single arm. Open-labelled, not randomized
* Healthy volunteers

Duration:

Information visit:

Oral and written information about the evaluation is given by the PI or his/her representative. Subjects can continue to visit 0, inclusion visit, the same day - if the subject has decided on participation and if practically possible.

Visit 0 - Inclusion visit:

Informed consent signed. Subjects can continue to visit 1 - test visit the same day - if practically possible.

Visit 1 - test visit:

1h test visit at Rigshospitalet. Fertile females will be asked to perform a pregnancy test. Subject is asked about symptoms for urinary tract infections (frequent urination, stinging or pain at urination). If negative for these symptoms, the subject will be catheterised with (SpeediCath® Standard, male/female, Nelaton tip depending of the gender) with fitted pressure sensor. The urine is led into a standard urine flowmeter.

Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity

Exclusion Criteria:

1. Previous history of genitourinary disease in-cluding congenital abnormalities and surgical procedures performed in the urinary tract
2. Symptoms of urinary tract infections (fre-quent urination, stinging and pain at urina-tion)
3. Participation in any other clinical investiga-tions during this investigation (Inclusion → termination)
4. Known hypersensitivity toward any of the test products
5. Positive pregnancy tes for women
Sex Difference of Coronary Microvascular Dysfunction in Patients with Non-obstructive Coronary Artery Disease

Sex difference of coronary microvascular dysfunction evaluated by coronary flow reserve will be assessed in patients with non-obstructive coronary artery disease

The investigators will select consecutive patients who experienced chest pain but had no significant coronary artery stenosis (\<50% stenosis). Coronary microvascular function will be evaluated by adenosine stress echocardiography. Coronary blood flow velocities will be measured at 1, 2, and 3 min after adenosine infusion.

Sex difference of coronary microvascular dysfunction evaluated by coronary flow reserve will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Typical/atypical chest pain or ischemic symptoms including dyspnea
* No significant coronary artery stenosis (\<50% stenosis) in coronary angiography or computed tomography

Exclusion Criteria:

* ≥ Moderate valvular heart disease
* Congenital heart disease
* Chronic renal failure (estimated glomerular filtration rate \<30 ml/min/1.73m2) or end-stage renal failure undergoing hemodialysis or peritoneal dialysis
* Asthma, chronic obstructive pulmonary disease and primary pulmonary hypertension
* Receiving anticancer drugs
* Vasculitis associated with autoimmune diseases
* Atrioventricular block with more than second degrees, symptomatic bradycardia, cryo-node failure syndrome, Wolff-Parkinson-White (WPW) patients
Classification of Ankle Injury Observed With X-ray Combined With Magnetic Resonance Imaging

To verify whether X-ray combined with MRI is able to carry out correct fracture classification and postoperative evaluation in patients with ankle fractures.

History and current related studies Intraarticular fractures and ruptures of ligaments around the joint often occur after ankle injury. Early correct treatment can effectively help joint repair, and reduce the incidence of serious complications. Ankle fractures are one of the common orthopedic fractures. X-ray is a common method for detecting ankle injury, can determine the fracture site, type and extent. However, X-ray is difficult to display ankle fracture, bone fragments, displacement, or ligament injury, so it cannot make accurate fracture classification or formulate treatment programs.

Magnetic resonance imaging (MRI) can clearly show the ankle ligament, tendon, and cartilage injury, is advantageous in the diagnosis of ligament injury after ankle fracture, and can provide accurate imaging information. MRI can provide accurate preoperative assessment of clinical indicators for the rational formulation of treatment programs to reduce complications. The observation of ankle contusion observed by MRI is conducive to analyzing the mechanism of ankle joint injury.

Therefore, X-ray combined with MRI would perfectly verify soft tissue injury after ankle fractures so as to make effective surgical program.

Adverse events Adverse events including incision pain, incision nonunion, ankle pain, peripheral nerve injury of ankle joint, ankle joint inflammation, and soft tissue injury. Severe adverse events are events occurred during clinical trial, including requiring hospitalization, prolonged hospitalization, disability, inability to work, life-threatening, or fatalities. If severe adverse events occur, investigators would report details, including the date of occurrence and measures taken to treat the adverse events, to the principle investigator and the institutional review board within 24 hours.

Data collection, management, analysis and open-access

1. Case report forms with demographic data, disease diagnosis, accompanying diseases, drug allergy history, and adverse events were collected.
2. Data were processed using Epidata software (Epidata Association, Odense, Denmark), collated, and then recorded electronically. All data regarding this trial were preserved by the First Hospital, Hebei Medical University, China.
3. The electronic database was statistically analyzed by a professional statistician who created an outcome analysis report that was submitted to the lead researchers.

Eligibility Criteria:
Inclusion Criteria:

* Ankle fractures patients detected by X-ray
* Highly suspected ankle ligament injury
* History of obvious trauma
* Complete clinical data
* Irrespective of sex and age
* Sign the informed consent

Exclusion Criteria:

* Cardiopulmonary function cannot tolerate anesthesia or surgery
* Open fractures of ankle joint
* Old fracture of the ankle joint
Imatinib Mesylate After a Donor Stem Cell Transplant in Treating Patients With Philadelphia Chromosome-Positive Leukemia

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate after a donor stem cell transplant may prevent the recurrence of Philadelphia chromosome-positive leukemia.

PURPOSE: This phase I/II trial is studying the side effects of giving imatinib mesylate after a donor stem cell transplant and to see how well it works in treating patients with Philadelphia chromosome-positive leukemia.

OBJECTIVES:

Primary

* Determine the safety of adjuvant imatinib mesylate after allogeneic hematopoietic stem cell transplantation (AHSCT) in patients with high-risk Philadelphia chromosome-positive leukemia.

Secondary

* Determine the bcr/abl transcript load during the first 90 days after AHSCT in patients treated with this drug from the time of engraftment.
* Determine the 1-year survival of patients treated with this drug.

OUTLINE: This is an open-label, pilot, multicenter study.

Beginning within 14-30 days after allogeneic stem cell transplantation, patients receive oral imatinib mesylate once daily until 1 year after transplantation. Treatment continues in the absence of unacceptable toxicity or disease progression.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of 1 of the following:

  * Acute lymphoblastic leukemia or chronic myeloid leukemia (CML) characterized by p\^190 and/or p\^210 bcr/abl gene rearrangement
  * Accelerated or blastic phase CML
  * CML in second or greater chronic phase
* No imatinib mesylate-resistant leukemia
* Planned allogeneic hematopoietic stem cell transplantation

  * Availability of an appropriately matched related or unrelated donor
  * Autologous or nonmyeloablative transplantation is not allowed
* None of the following within 4 days after the date of neutrophil engraftment\*:

  * More than 5% marrow blasts
  * Circulating peripheral blood leukemic blasts
  * Aberrant antigen expression on marrow myeloblasts ≥ 1% by multidimensional flow cytometric assay
  * Presence of bcr/abl in \> 5% of marrow interphase nuclei by fluorescent in situ hybridization
  * More than 1 of 20 Philadelphia chromosome-positive marrow metaphases
  * CNS involvement by leukemia NOTE: \*The date of neutrophil engraftment is defined as the second consecutive day at which the peripheral blood absolute neutrophil count exceeds 500/mm3

PATIENT CHARACTERISTICS:

Performance status

* Not specified

Life expectancy

* At least 2 months

Hematopoietic

* See Disease Characteristics
* Absolute neutrophil count ≥ 1,200/mm\^3 (use of filgrastim \[G-CSF\] allowed)

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known imatinib mesylate hypersensitivity
* No other disease that severely limits life expectancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics
Escalating Clopidogrel by Involving a Genetic Strategy - Thrombolysis In Myocardial Infarction 56

To determine whether higher as compared with lower maintenance doses of clopidogrel can adequately improve the degree of platelet inhibition in carriers of a reduced-function CYP2C19 allele.

Clopidogrel blocks the P2Y12 ADP receptor on platelets and has been shown to reduce cardiovascular events in acute coronary syndrome (ACS) patients.However, inter-patient variability in the pharmacodynamic response to clopidogrel is well recognized, and patients with lesser degrees of platelet inhibition in response to clopidogrel have been shown to be at increased risk of cardiovascular events.

One potential source of this variability is the metabolism of clopidogrel, which is a pro-drug requiring biotransformation to become an active antiplatelet compound. Cytochrome P-450 (CYP) enzymes play a role in the metabolism, and carriers of reduced-function genetic variants in CYP2C19 (\~30% of the population) have lower active clopidogrel metabolite levels, diminished platelet inhibition, and higher rates of adverse cardiovascular events as compared with non-carriers in the setting of treatment with standard maintenance doses of clopidogrel.

Aim: To determine whether higher as compared with lower maintenance doses of clopidogrel can adequately improve the degree of platelet inhibition in carriers of a reduced-function CYP2C19 allele.

Hypotheses: The primary hypothesis is that subjects who carry a reduced-function CYP2C19 allele will have improvement in platelet inhibition with higher maintenance doses of clopidogrel.The secondary hypothesis is that higher maintenance doses of clopidogrel in carriers of a reduced-function CYP2C19 allele will result in similar platelet inhibition as compared to a standard maintenance dose of clopidogrel in non-carriers.

Eligibility Criteria:
Inclusion Criteria (major):

1. Between 18 and 75 years of age, inclusive.
2. Have an indication for the use of clopidogrel defined as either spontaneous MI \[hospitalized with final diagnosis of MI, excluding periprocedural or definite secondary MI (e.g., due to anemia or hypertensive emergency)\] or PCI within the past 6 months.
3. Clinically stable and at least 4 weeks following the MI or PCI.

Exclusion Criteria (major):

1. Conditions that alter platelet function.
2. Conditions that increase bleeding risk.
Influence of Physical Treatments of Human Milk on the Kinetics of Gastric Lipolysis in Preterm Newborns

The optimization of newborns nutrition is a challenge especially for preterm newborns for whom nutrition plays a crucial part in cerebral and global development. Human milk is considered as the best food for newborns. Several short and long-term beneficial health effects were attributed to breastfeeding and have induced the increase of human milk in preterm newborns nutrition.

Whereas the chemical composition of infant formula has been optimized to mimic human milk, there is still a major difference between the structure of human milk and commercial infant formulas. It is well known in adult nutrition that the structure of emulsions influences their susceptibility to hydrolysis, such results have been obtained either on in vitro or in vivo studies.

Human milk is a natural emulsion (oil in water). Lipids droplets are dispersed under the form of entities called milk fat globules (average diameter 4 µm, span 0.1-20 μm). The globules are stabilized by a trilayered membrane composed mainly of polar lipids (phospholipids, sphingolipids and gangliosides), of proteins, neutral lipids and other minor compounds.

The physical treatments apply to human milk or more generally to bovine milk to pasteurize or stabilize the milk modify the structure of the natural emulsion. Heat treatment for instance induces whey proteins denaturation and the adsorption of protein aggregates on the surface of the milk fat globules. Heat treatment also leads to the denaturation of bile salt stimulated lipase. These effects limit intragastric lipolysis in preterm newborns.

Conversely, reduction of milk globules size, by homogenisation of milk, increases the specific surface available for lipase adsorption and limits the lost of fat during enteral administration of milk. Such treatment could thus enhance gastric lipolysis and improve fat absorption of preterm newborns.

The objective of this trial is to evaluate the effects of physical treatments (pasteurization and homogenisation by ultrasonication) applied to human milk on gastric lipolysis and milk destructuration. This trial is conducted, in vivo, on preterm newborns.


Eligibility Criteria:
Inclusion Criteria:

* Premature neonates born before 32 weeks of gestation
* Newborn dwelled near Rennes
* Volume of enteral nutrition \> 120 mL/kg/j (Day 0)
* Written-informed parental consent for the study

Exclusion Criteria:

* Digestive congenital anomalies
* Antecedent of enterocolitis
* Patient included in other study
* Abdominal distension on Day 0
* Treatment by morphine or catecholamine on Day 0
The Effect of Combination Therapy of Oral MB and PRP-FG in Patients With Non-healing Diabetic Foot Ulcer

The aim of this study is to evaluate the chance of non-healing diabetic foot ulcers repair by improving the condition of lack of oxygen or hypoxia in the wound area caused by diabetes using methylene blue along with the use of platelet-rich plasma-fibrin glue as an effective treatment for wound healing.

The current study assesses the effects of methylene blue along with the use of platelet-rich plasma-fibrin glue on wound healing in patients with nonhealing diabetic foot ulcers (non-healing DFU). This randomized controlled trial is performed on 20 patients with non-healing DFU. Patients were treated with PRP-FG dressing plus 200 ml of oral methylene blue dissolved in milk(intervention group) or PRP-FG dressing plus placebo (200 ml of milk) (control group) for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Having a Diabetic ulcer grade II and IV based on Wagner's classification on the sole, medial, or lateral part of the foot (including all surfaces of the toes)
* Having a single ulcer on the feet and extremities (toes, soles, heels) with no significant reduction in ulcer size (\<20%) despite the use of best treatment methods for at least four weeks
* If there is more than one non-healing wound, choose the largest wound
* The size of the wound surface (length × width) between 2 cm2 and 20 cm2
* No smoking, alcohol, and drug addiction based on the patient's self-report
* Not taking drugs that may interfere with wound healing, such as Corticosteroids, immunosuppressants, and cytotoxic agents
* Not having a concurrent chronic disease that may cause problems in wound healing, such as cancers, vasculitis, no history of known severe kidney, liver, and heart disease, such as liver cirrhosis, active hepatitis, dialysis, etc.
* Not taking antidepressants
* Insensitivity to milk lactose
* Not having Glucose 6-phosphate dehydrogenase (G6PD) deficiency
* Confirmed, informed, signed consent form
* Ankle Brachial Index (ABI) higher than or equal to 0.7

Exclusion Criteria:

* Do not be treated with methylene blue
* The confirmed presence of osteomyelitis, or if there is suspicion of osteomyelitis
* The subject is pregnant or intends to become pregnant during the test period
* The patient is known to have mental, developmental, physical, and emotional disorders
* The occurrence of certain medical conditions
* The presence of a wound with a clear and severe infection, which is characterized by significant purulent secretions or extensive cellulitis, or gangrene requiring amputation
* Evidence of venous, ischemic, neurotrophic ulcers (numbness, tingling, lack of Achilles tendon reflex) and traumatic wounds in the patient
* Failure to refer the patient more than two times to the mentioned center for follow-up and dressing change
* Hypersensitivity reaction to methylene blue
* Platelet count less than 100,000
* The patient's lack of consent to continue cooperation
Coaching for HCV and HIV

The objective of this study is to determine the feasibility and acceptability of a peer recovery coach (PRC) intervention to improve linkage to hepatitis C (HCV) and/or human immunodeficiency virus (HIV) care, treatment initiation, and evaluation for HIV pre-exposure prophylaxis (PrEP) (when applicable) among individuals with a history of opioid use disorder accessing a substance use low-barrier-to-access (LBA) walk-in clinic.

In-depth interviews will be administered to participants at baseline, three- and six-months for study participants (40 total participants). The investigator will also follow-up with the per recovery coach and administer surveys to assess the feasibility of a peer recovery coaching intervention in improving HCV/HIV related linkage to care and management. Patient medical records and peer recovery coach monthly reports will be accessed and reviewed to determine fidelity to research protocols.

\*NOTE\* Due to the COVID-19 pandemic, surveys were conducted via telephone and not all participants could be contacted. Therefore, the number of results from participants at three months and six months vary. The data gathered are from participants that were reachable and completed the surveys.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with opioid use disorder, non-reactive HIV antibody test and reactive HCV antibody testing at the BMC LBA walk-in clinic
* Able to speak English
* Individuals providing contact information of two family members or friends
* Individuals signing a medical records release form

Exclusion Criteria:

* Individuals already linked to substance use care
* Individuals co-infected with HIV and HCV and engaged in care
Use of Fish Oils to Reduce the Frequency and Duration of Episodes of Atrial Fibrillation in Patients With Paroxysmal Atrial Fibrillation.

The purpose of this study is to investigate whether fish oil supplements may reduce the frequency and duration of paroxysmal atrial fibrillation episodes.

Atrial fibrillation is a heart condition which effects a large percentage of the population .

Atrial fibrillation is a condition frequently experienced by people who have had pacemakers inserted .

Certain Pacemakers have sophisticated monitoring features that are able to recognise episodes of atrial fibrillation.

Fish oil supplements may be of benefit to patients with heart problems.Recent evidence suggests that fish oils may be beneficial to patients with rhythm disturbances.

By interrogating pacemakers this study will investigate the effect of fish oil supplements on the frequency and duration of episodes of atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have had at least 2 previous episodes of atrial fibrillation and an implanted pacemaker.

Exclusion Criteria:

* Patients with chronic atrial fibrillation