cyrilzakka/clinical-trials huggingface dataset:
Treosulfan Based Conditioning Myelodysplastic Syndrome (MDS)

This is a multicenter, multinational, non-randomized, non-controlled open-label phase II trial to evaluate the safety and efficacy of treosulfan in a combination regimen with fludarabine as conditioning therapy prior to allogeneic stem cell transplantation (SCT) in patients with MDS.

The aim is to demonstrate a clinical benefit compared to historical data with intravenous busulfan.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with myelodysplastic syndrome, (MDS) according to WHO classification (\< 20 % myeloblasts in peripheral blood or bone marrow at initial diagnosis) indicated for allogeneic transplantation
2. Availability of an HLA-identical sibling donor (MRD) or HLA-identical unrelated donor (MUD) HLA-identity defined by the following markers: HLA-A, -B, -DRB1, DQB1.
3. Target graft size (unmanipulated) bone marrow: 2 to 10 x 106 CD34+ cells/kg BW recipient or at least 2 x 108 nucleated cells /kg BW or peripheral blood: 4 to 10 x 106 CD34+ cells/kg BW recipient
4. Age \> 18 and \< 60 years
5. Karnofsky Index \> 80 %
6. Adequate contraception in female patients of child-bearing potential
7. Written informed consent

Exclusion Criteria:

1. 'Secondary' or therapy-related MDS with known history of exposure to cytotoxic alkylating drugs and/or radiation therapy
2. Previous AML-induction therapy with more than two courses (e.g. in case of blast excess)
3. Previous allogeneic transplantation
4. Severe concomitant illnesses / medical conditions (e.g. impaired respiratory and/or cardiac function)
5. Known and manifested malignant involvement of the CNS
6. Active infectious disease
7. HIV- positivity or active hepatitis infection
8. Impaired liver function (Bilirubin \> upper normal limit; Transaminases \> 3.0 x upper normal limit)
9. Impaired renal function (Creatinine-clearance \< 60 ml/min; Serum Creatinine \> 1.5 x upper normal limit).
10. Pleural effusion or ascites \> 1.0 L
11. Pregnancy or lactation
12. Known hypersensitivity to treosulfan and/or fludarabine
13. Participation in another experimental drug trial within 4 weeks before study
14. Non-co-operative behaviour or non-compliance
15. Psychiatric diseases or conditions that might impair the ability to give informed consent
Edoxaban Management in Diagnostic and Therapeutic Procedures

Patients receiving Novel Oral Anticoagulation (NOACs) undergo diagnostic and therapeutic procedures at a rate of 10% per year. Short half-lives and rapid onset of action allow for short periods of NOAC interruption without heparin bridging. There is only minimal information on the peri-procedural usage pattern of edoxaban and the related outcome data currently available. Therefore, further real-world clinical data on the peri-procedural usage pattern of edoxaban within any diagnostic or interventional procedure in patients with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE) will be collected in this registry.

Patients treated with edoxaban and with a planned or unplanned diagnostic or interventional procedure will be enrolled in this study in order to evaluate the peri-procedural dosing of edoxaban in patients with diagnostic or therapeutic procedures and collect details of the type diagnostic or therapeutic procedures. Patients from 7 different countries and care settings (primary care, secondary care, and different medical specialties) will be enrolled. The study will last until approximately 2000 procedures have been documented, e.g., until about 2000 participants are enrolled, which is expected to take approximately 2.5 years. Any relevant diagnostic or interventional procedure reported will be collected and documented in the electronic case report form (eCRF). Patients will be followed for 30 days after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients taking edoxaban for a therapeutic indication for edoxaban according to SMPC including NVAF, DVT or PE
* Patients with a planned or unplanned diagnostic or therapeutic procedure
* Written informed consent
* Availability of patients for follow-up by telephone by the site
* No concurrent participation in an interventional study (simultaneous participation in other non-interventional studies is possible)

Exclusion Criteria:

* None
Assessment of Non-medical Use of Misoprostol in Case of Miscarriage or Threatened Miscarriage.

Non-medical used of misoprostol for abortion is a growing concern in Guadeloupe. Such situation is reasonable for countries in which abortion is not easy to obtain or prohibited. However regarding the risk of complications, it is less understandable in region like Guadeloupe where legal abortion with medical assistance is accessible for all and free.

The aim of the study is to investigate on the amount of misoprostol taken by women in Guadeloupe, by doing an analytical measurement. The aim is to evaluate batter this practice in Guadeloupe, when the main objective of the study is to detect the presence or the absence of misoprostol in the urine sample of the woman coming at hospital for threatened miscarriage or miscarriage complications. Moreover, these abortions can be more important than spontaneous miscarriage.

Previous assessments in many countries as well in Guadeloupe were based on self-declaration. Such assessment is suspected to lead to underestimation. In addition, to our knowledge, no comparison has been done between those induced abortions and the natural miscarriages.

Illegal aspects of non-medical use of misoprostol and consequently bad self-declaration are hindrance to good assessment of the burden of such practice among patients asking for medical care at emergency unit for miscarriage or threatened miscarriage. They may also impair quality of evaluation of the relative risk associated to miscarriage threatened miscarriage induced by misoprostol compared to the same obstetrical complication without absorption of misoprostol. After a dose, misoprostol is quickly active and metabolised. It is mainly eliminated in urine. This elimination seems to be a way to increase the length of detection of the use of misoprostol. The aim of our study is to perform a detection of misoprostol in urine sample of patients hospitalised for a miscarriage or threatened miscarriage. This sample will be done during emergency cares. The study will not change the procedure of medical care of the patients during or after hospitalisation. All data will be obtained from information and result of tests normally done in such situation.

Eligibility Criteria:
Inclusion Criteria:

* inclusion criteria:
* All patients who come at the maternity emergency unit for miscarriage or threatened miscarriage by 24 weeks of amenorrhea or patient receiving misoprostol for voluntary abortion.
* Age ≥ 12 years old
* Patient insured under the French social security system

Exclusion Criteria:

* Refusal to participate in the study
* Age \< 12 years old
Preoperative Patient Education for Enhanced Recovery After Colon and Rectal Surgery

The aim of this experimental study is to evaluate whether \*\*preoperative patient education can improve outcomes for individuals undergoing colorectal surgery. This study will focus on adult male and female patients with colon cancer scheduled for colorectal surgery through colonoscopy, excluding those undergoing open surgery.

The primary questions this study seeks to answer are:

* Do patients who receive preoperative education experience significantly lower levels of preoperative anxiety compared to those receiving routine hospital care?
* Do patients receiving nursing instructions report significantly lower levels of oral pain postoperatively compared to those who do not?
* Does preoperative education lead to higher levels of patient satisfaction compared to standard care?

Researchers will compare a study group that receives preoperative education to a control group receiving routine hospital care to determine the effectiveness of the intervention.

Participants will be asked to:

* Complete a demographic and medical history questionnaire.
* Utilize the Pain Numeric Rating Scale (NRS-11) to self-report pain levels.
* Participate in assessments using the Amsterdam Preoperative Anxiety and Information Scale (APAIS)\*\*.
* Complete a satisfaction survey using the Colorectal Surgical Patient's Satisfaction Tool after surgery.

The study aims to assess the impact of preoperative education on anxiety, pain management, and overall patient satisfaction.

Patient education and engagement are fundamental components of modern integrated colorectal care pathways. Surgeons and nurses play a crucial role in providing comprehensive education about what patients can expect during both the preoperative and postoperative phases of surgery. Setting clear expectations early-especially regarding the anticipated discharge date-significantly influences the postoperative recovery journey.

Enhanced Recovery After Surgery (ERAS) is an evidence-based, patient-focused strategy aimed at optimizing surgical outcomes by streamlining the recovery process. Initially designed for colorectal procedures, ERAS protocols have now been adapted for various surgical disciplines, with many of its principles safely applicable to most perioperative patients. The primary objective of ERAS is to minimize the physical and emotional strain of surgery, facilitating quicker recovery, reducing complications, and decreasing the length of hospital stays.

While much of the research on the ERAS program has traditionally centered on the surgeon's role, the multidisciplinary nature of patient care has brought increased recognition to the nurse's contribution. Nursing professionals are now acknowledged as vital components of the ERAS framework, playing a key role in ensuring the program's success.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female patients with colon cancer undergoing colorectal surgery via colonoscope.

Exclusion Criteria:

* patients with open surgery.
Topo-Pachymetric Customized Accelerated Epi-On Vs Accelerated Epi-Off Corneal Cross Linking in Keratoconus Management

The objective of this study is to compare the clinical effectiveness and safety of Topo-Pachymetric Customized Accelerated Epithelium-On (aCFXL) to Standard Accelerated Epithelium-Off (aCXL) Corneal Collagen Cross-Linking in the management of keratoconus. The study aims to evaluate visual and structural outcomes, to provide valuable insights into optimizing treatment strategies.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 years or older
2. Corrected distance visual acuity (CDVA) of ≥ 0.3 Snellen.
3. Central corneal thickness (de-epithelialized) of ≥ 400 micron.
4. Corneal endothelial count of ≥ 2000.

Exclusion Criteria:

1. Previous eye surgery
2. The presence of lesions other than keratoconus, central or paracentral scaring
3. History of Cross linking
4. History of viral keratitis
5. Connective tissue diseases
6. Pregnancy or lactation during the study.
7. The presence of nystagmus
Comparison Between Centrifugation Based and Membrane Based Plasma Exchange

This study aims at comparing centrifugation based therapeutic plasma exchange (cTPE) versus membrane based therapeutic plasma exchange (mTPE) as regards performance, effectiveness and adverse events in patients indicated for TPE.

* Study setting: Patients of this study were recruited from the hemodialysis unit of Alexandria Main University Hospital.
* Study design: Randomized prospective crossover study.
* Study population: Twenty patients having clinical indication for TPE.
* They were divided into 2 groups by 1 to 1 randomization Group A: ten patients received the first session of TPE by cTPE and the second session was performed by mTPE 48 hours later.

Group B: ten patients received the first session of TPE by mTPE and the second session was performed by cTPE 48 hours later.

Only the results of 2 sessions for each group were recorded in the study, even if the patients needed further sessions of TPE.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged more than 18 years old having indication for plasma exchange (based on American Society for Apheresis (ASFA) therapeutic category 1, 2, 3).

  * Category I: includes disorders for which TPE is accepted as first-line therapy, either as primary stand-alone treatment or in conjunction with other modes of treatment. Examples include Guillain-Barre syndrome, acquired thrombotic thrombocytopenic purpura, and erythrocytapheresis in sickle cell diseases with certain complications (eg, stroke).
  * Category II: includes disorders for which TPE is accepted as second-line therapy, either as a stand-alone treatment or in conjunction with other modes of treatment. Examples include life-threatening hemolytic anemia for cold agglutinin disease or Lambert-Eaton myasthenic syndrome.
  * Category III: includes disorders for which the optimum role of apheresis therapy is not established. Decision making should be individualized. Examples include TPE for hyper-triglyceridemic pancreatitis or extracorporeal photopheresis for nephrogenic systemic fibrosis.
* Approval to sign a written consent.

Exclusion Criteria:

* Refusal to participate in the study.
FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects

The purpose of this study is to address an Food Drug and Administration (FDA) request to provide safety data in pre-asthmatic patients, ages 6 months to \<12 months, following administration of fluticasone propionate HFA.

A repeat-dose, open-label, 2-session study to assess the systemic exposure to, and pharmacodynamics of, fluticasone propionate HFA inhalation aerosol 88mcg administered twice-daily for 28 days delivered via an MDI and valved holding chamber with infant facemask to subjects ages 6 months to \<12 months who have experienced 2 or more wheezing episodes in the preceding 6 months

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have experienced 2 or more wheezing episodes in the previous 6 months.
* Subjects may not have taken any corticosteroids in the 4 weeks prior to dosing
* Parents/guardians should be able to read and comprehend diary information collected throughout the study
* Parents must be able to demonstrate the ability to use the facemask and spacer used to administer study drug

Exclusion criteria:

* Subjects who weigh less than 7 kg
* Subjects who are taking any drugs that inhibit or induce the cytochrome P450 isoform
* Any parents who have a history of psychiatric disease, intellectual deficiency, substance abuse that would compromise the validity of the consent
A Mobile Intervention to Improve Uptake of PrEP for Southern Black MSM

This study will develop and test an interactive mobile messaging intervention to improve engagement in care related to Pre-exposure Prophylaxis (PrEP) and decrease HIV risk behaviors for Black men who have sex with men living in the Southern U.S. The mobile messaging intervention will include interactive text messaging and free, publicly available links to websites and YouTube videos. During the intervention participants will gain information about their health, improve motivation for engagement in PrEP related care, and build skills for healthy behaviors. Participants will also receive intervention materials to help decrease frequent barriers to care. If the intervention is found to be effective, it can be tested in a larger study and then disseminated.

The uptake of Pre-Exposure Prophylaxis (PrEP) has been slow for young Black men who have sex with men (BMSM) living in the Southern United States. This is a significant issue because eight of the ten states with the highest rates of new HIV infections are located in the South. Jackson, Mississippi (MS) (the site of this project) has the second highest AIDS diagnosis rate in the nation, and the highest rate of HIV infection for young urban Black men who have sex with men. This study will develop and test an engaging, interactive, and cost effective mobile messaging intervention to improve linkage to PrEP care for BMSM (18-35 yrs) living in Jackson, MS. BMSM eligible for PrEP, receiving care at the University of Mississippi Medical Center sexually-transmitted infections (STI)/HIV testing clinics, will be texted interactive links to publicly available, online content about PrEP and HIV prevention. Links will be sent to PrEP eligible BMSM by 8-16 interactive text messages over 4 weeks. The material used in the intervention will be consistent with the Information Motivation Behavior (IMB) Model and will address cultural and structural barriers to initiating PrEP care. A small randomized controlled study among 66 new participants in the clinics will examine the preliminary efficacy of the intervention compared to enhanced standard of care on attendance at a PrEP Services Appointment (the first step in initiating PrEP care). It is hypothesized that, compared to BMSM receiving enhanced standard of care, BMSM receiving the PrEP Mobile Messaging Intervention will show greater attendance at a PrEP Services Appointment and decreased HIV risk behavior at 4 and 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Black MSM
* Eligible for PrEP
* Visit STI/HIV testing clinics at University of Mississippi Medical Center
* Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment

Exclusion Criteria:

- Involved in another PrEP or HIV prevention related study
Pressure Injury Prediction and Education Model Using a Mobile Application System

Pressure injuries are common in the elderly and patients who reduced physical activities. Its complications significantly impact the health care system and social burden, even causing the death rate to be as high as 68%. This study aims to collect medical data regarding pressure injuries during hospitalization for developing the Pressure Injury Prediction and Education Model using a mobile application system. It can offer a prediction on the risk of pressure injury and be used as a teaching aid for pressure injury care, providing a personalized and evidence-based nursing information platform for patients, caregivers, and health professionals.

This study will conduct a randomized controlled trial among 160 primary caregivers of patients with pressure injuries. They will be randomly assigned to the control group or the experimental group. In the control group, patients are routinely cared for in the ward, and this group will have no intervention. Routine care includes face-to-face training and educational pamphlets by the ward nurse. The experimental group will be provided a pressure injury prediction of the patient and personalized care information of pressure injury by a smart care platform. The participants (primary caregivers) will fill out the questionnaires online at admission (baseline-T0)and before the patient is discharged(T1). The questionnaires will collect the following data, including demographic information(only T0), knowledge, self-efficacy, anxiety, depression of pressure injury care(T0\&T1), and satisfaction of the smart care platform(only T1). The time to fill out the questionnaires will be about 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

1. The primary caregiver for patients with pressure injury in the hospital.
2. The primary caregiver must be at least 20 years old, have clear consciousness, express independently, communicate in Mandarin and Taiwanese, use an Android phone by himself, and use a mobile phone application after explanation.

Exclusion Criteria:

The primary caregiver has a mental or cognitive impairment, cannot express consciousness clearly, or cannot operate mobile apps.
Study of the Diet in Patients With the Diagnostic of Acute Pancreatitis

Acute pancreatitis (AP) is a common condition in emergency services worldwide. Approximately 85% of AP are mild and the patients usually recover within 1 to 2 weeks, not requeiring any critical care and organ support. The management of mild AP conventionally involves fasting, intravenous hydration and adequate analgesia until pain improves in order to prevent stimulation and allow the pancreas gland to rest.

The current guidelines recommend the oral food intake should be tried as soon as possible, and beneficial effects or early enteral nutrition with mild AP have been reported in literature.

Then, early oral refeeding (EORF) after mild and moderate AP is beneficial, but the optimal timing and starting criteria are unclear. Even now, refeeding after mild and moderate AP is typically started until clinical symptoms have resolved and pancreatic enzymes are decreasing, in a successively increasing manner. The aim of this study is to evaluate length of hospital stay, clinical findings and complications for EORF with immediately full caloric intake in patients with mild and moderate AP.

This is prospective, randomized, controlled, multicentre trial. Patients with mild and moderate acute pancreatitis (AP) will be randomly in two groups: group A: with early oral refeeding (EOR) with low fat solid diet (LFSD), started from the first day of admission in the hospital, and group B: with Nil Per Oral (NPO), until the symptoms, signs, inflammatory parameters of AP have resolved.

The primary and several secondary endpoints will be obtained and EORF with LFSD will improve the following measures of outcome:

1. Length of hospital admission (the primary endpoint)
2. Serum amylase, lipase, electrolytes, calcium, urea, creatinine, liver function tests, C-reactive protein (biomarker of inflammation), nutritional parameters (albumin, prealbumin, cholesterol, triglycerides) and full blood count - routine blood tests performed daily until normalization of serum lipase or until discharge.
3. Weight, at hospital admission and discharge, and at day 30 post-discharge clinic follow-up.
4. Systemic complications including hemodynamic instability, renal failure, intensive care admission, surgery, radiological and endoscopic procedures.
5. Pain and Analgesic requirement.
6. Local complications including pancreatic necrosis, abscess, pseudocyst.

Eligibility Criteria:
Inclusion Criteria:

* 1) Diagnosed of AP by at least two of these three criteria: compatible abdominal pain, amylase or lipase level superior in three-fold respective laboratory baseline levels, and suitable findings in imaging techniques (CT, ultrasound or MRI)
* 2) age \> 18 years, sign consent form.

Exclusion Criteria:

* 1) pregnant o breastfeeding women;
* 2) abdominal pain lasting \>96 horas before admission;
* 3) the possibility of poor oral intake for reasons other than AP;
* 4) Pancreatic neoplasm, endoscopic retrograde cholangiopancreatography or trauma etiology;
* 5) Chronic pancreatitis;
* 6) Randomization greater the 12 hours after admission
A Study of GC1102(Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients

The purpose of this study is to evaluate the efficacy and safety of GC1102 in combination of Nucleo(t)ide analogues (NAs) in patients with chronic hepatitis B


Eligibility Criteria:
Inclusion Criteria:

* Patients who had this study information explained to them and understood it, voluntarily decided participation, and provided written consent
* Patients who Aged ≥19 and ≤ 65 years at the time of signing the consent form
* Patients with chronic hepatitis B who have been taking Nucleos(t)ide analogue antivirals 24 weeks before screening
* Patients whose HBsAg and HBV DNA in blood; 10 IU/mL ≤ HBsAg titer ≤ 1,000 IU/mL and negative(-; below the limit of detection of 10 IU/mL) HBV DNA in the screening test

Exclusion Criteria:

* Patients who have Hepatic diseases (e.g., autoimmune hepatitis) from causes other than hepatitis B
* Patients who have history of liver transplantation, or liver transplantation schedule during the study
* Patients who co-infected with HAV, HCV, HDV and HIV
* Patient with Vasculitis
* Patients who had a loss of blood or donated blood of ≥ 400mL within 8 weeks before the screening
* patient who have active infection(other than chronic hepatitis B infection) requiring continual treatment with antibiotics or antivirals (except for clinically insignificant temporary infection such as cold)