cyrilzakka/clinical-trials huggingface dataset:
Eltrombopag Treatment in Patients With Prolonged BM Toxicity After CART

Treatment with chimeric antigen receptor-T cell (CAR-T) is successful in patients who have not responded to chemotherapy or bone marrow transplantation but it may provoke side effects and long-term complications. Early and specific side effects include cytokine release syndrome and neurological toxicity. In addition, there are also late side effects. The most prominent of which is bone marrow damage and lack of recovery of blood counts after treatment.

In this study, patients with prolong aplasia after CAR-T will recieve eltrombopag to enahnce bone marrow recovery.

CAR-T therapy is the standrad of care in patients with relapse/refractory B cell agressive lymphoproliferative diseases. Prolonged cytopenia is a not uncommon side effect and is associated with susbstantial morbidity and in severe cases also with mortality. The pathobiologic process that causes bone marrow injury is not known and in order to find appropriate treatment it is important to expand the knowledge regarding this toxicity. Current treatment options for bone marrow suppression includes growth factor therapy (GCSF), steroids and immunoglobulins. .

The investigators hypothesize that CART cells directly suppress or create inflammatory process in bone marrow. This process may resemble aplastic anemia, a marrow aplasia that occurs secondary to inflammatory process.

Treatment of aplastic anemia is based on the administration of eltrombopag, that causes a thrombopoietin-mimetic blood cells to develop and multiply. This treatment demonstrated an increase in the amount of platelets and neutrophils in patients with aplastic anemia and is approved by the health authorities around the world and in Israel as a standard treatment for this disease. There are several reports of successful use of altrombopag in patients after CART who have developed marrow toxicity and in patients after bone marrow transplantation whose blood counts are low.

In this study, patients with prologed aplasia after CART cells therapy, will be given eltrombopag in a purpose to incrase bone marrow function. In addition, the investigators will perform several assays to shed more light on the basic pathologic process that causes the bone marrow aplasia.

Eligibility Criteria:
Inclusion Criteria:

1. Willing to participate in the study and able to sign an informed consent form.
2. Patients with B cell lymphoma or multiple myeloma who were treated with CART and demonstrated cytopenia on day 14 after CART administration. Cytopenia definition: absolute neutrophil count \<500 neutrophils/ul and/or platelets \<50,000 mm3
3. Bone marrow demonstrates hypoplasia (cellularity less than 30%) 14 days after CART administration.

   -

Exclusion Criteria:

1. Creatine \> 2.5 mg / dL
2. Disorder in liver enzymes: bilirubin above 2 mg/dl , AST or ALT 5 times the normal.
3. Active infection
4. Active hemophagocytic syndrome
5. Evidence of a viral or pharmacological disease that causes bone marrow injury
6. Susceptibility to eltrombopag
7. Evidence of disease in the bone marrow -
Precision Antibiotic Dosing for Appendectomy

This research is studying a drug called cefoxitin already approved by the Food and Drug Administration (FDA) to reduce the risk of infection after surgery to remove an appendix. Researchers are studying a large group of people to continue to learn how best to dose antibiotics. This research will compare the current standard treatment which is a single dose prior to surgery to a new method that includes adding another dose of cefoxitin within 30 minutes of starting the surgery. This study will measure cefoxitin concentrations in blood, fat, and appendix tissue samples to compare the standard dosing method to our new method. This information will help us figure out the right dose of this drug to prevent infection after surgery to remove an appendix.

This interventional, phase 1 study aims to improve surgical site infection (SSI) prevention in patients undergoing appendectomy for uncomplicated appendicitis. Despite standard antibiotic prophylaxis, SSI rates remain high, with a pelvic abscess risk of 9.4%. Current prophylactic antibiotic regimens may not achieve optimal tissue concentrations, especially in fat and appendix tissue.

This study will evaluate the probability of target attainment (PTA) of cefoxitin, cefuroxime, and metronidazole in plasma, subcutaneous fat, and appendix tissue. A cohort of 46 adult patients will be randomized to receive standard-of-care antibiotics with or without an additional cefoxitin dose. Antibiotic concentrations will be measured in collected blood, fat, and appendix samples.

The study's primary objective is to determine whether a supplemental cefoxitin dose improves PTA compared to standard prophylaxis. Population pharmacokinetic modeling will validate the intervention's effectiveness in optimizing antibiotic exposure and reducing SSI risk. The results may inform future precision antibiotic dosing strategies for appendectomy and other acute care surgeries.

Primary Outcome Measure:

Probability of achieving 50% time above 8 mcg/mL (cefuroxime or cefoxitin) in appendix tissue between intervention and standard care groups.

Study Design:

Randomized, interventional, phase 1 study Enrollment: 46 participants Inclusion: Adults (\>18 years) undergoing appendectomy for acute appendicitis Exclusion: Pregnant individuals, prisoners, patients with perforation or abscess This study seeks to improve perioperative antibiotic management, reducing SSI rates while minimizing unnecessary antibiotic exposure and resistance development.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute appendicitis and plan to undergo appendectomy at the University of Michigan

Exclusion Criteria:

* Prisoners
* Patients that are pregnant
* Patients with perforation or abscess on CT Scan
Retinal Detachment - Demographic and Clinical Survey

Background:

Rhegmatogenous retinal detachment is an ophthalmic emergency that, without surgical repair, often leads to blindness. The incidence is about 1/10000/year. The leading causes are myopia and aging which cause retinal tears often resulting in retinal detachment. Patients commonly experience photopsia, floaters, and peripheral visual field loss.

Two different general surgical treatment options exist for retinal detachment; scleral buckling or vitrectomy. However, the precise indications for each approach have not been well established. Correct classification of the retinal detachment is important. The first step is to decide whether an intra- or extra-ocular surgical approach is more appropriate. Simple rhegmatogenous retinal detachments are usually treated extraocularly with scleral buckling surgery, whereas more complicated cases require intraocular primary pars plana vitrectomy and one or more of gas, silicone oil, laser therapy, or cryotherapy.

Study objectives:

The purpose of this study is to evaluate different surgical techniques for the treatment of retinal detachment. Data relating to retinal status before treatment, surgical treatment, post-operative anatomy and visual acuity, post-operative OCT, and intra- and post-operative complications will be collected.

Vitreous cytokines will also be analyzed to monitor intravitreal inflammation as a result of retinal detachment.


Eligibility Criteria:
Inclusion Criteria:

Patients who received surgery due to retinal detachment between January 2008 and Decemebr 2012.

Surgery was performed by either Ass.Prof.PD.Dr. Stefan Sacu or Prof.Dr. Michael Georgopoulos

Exclusion Criteria:

If patients had prior vitrectomy or scleral buckel. If patients had no adequate follow-up.
Acceptability, Usability and Preliminary Effectiveness of ChatGPT in Increasing Seasonal Influenza Vaccination Uptake Among Older Adults in Hong Kong

In this project, we will train a ChatGPT to provide real-time answers to questions related to the SIV for older adults in Hong Kong.

This study aims to evaluate the usability, acceptability, and preliminary effectiveness of the ChatGPT among 50 community-living people aged 65 years and above in Hong Kong.

The primary objectives are to evaluate the usability and acceptability (including the extent of usage and subjective experiences of behavioural, cognitive, and affective engagement) of the ChatGPT at the end of the 4-week intervention period (T1).

The secondary objectives are to evaluate the following conditions measured at T1, as compared to those measured at baseline (T0):

1. Self-reported uptake of SIV in the past month.
2. Changes in behavioural intention to receive SIV for the approaching flu season.
3. Changes in knowledge and attitudes related to SIV.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥65 years;
* Possession of a Hong Kong ID;
* Able to speak and comprehend Cantonese;
* Have a smartphone with internet access;
* Have not taken SIV for the approaching flu season.

Exclusion Criteria:

* With diagnosis of cognitive impairment or dementia;
* Either blindness or deafness;
* With known contraindications to the SIV as indicated by the Hong Kong Centre for Health Protection
Atorvastatin Reduces Chronic Inflammation and aVerage Epogen Dose (ARChIVED)

The specific aim of this trial is to determine whether initiating moderate- or high-intensity atorvastatin therapy in hemodialysis patient not previously on a statin reduces inflammation and lowers average Epogen utilization. Statin naive patients on maintenance HD will be started on 20mg atorvastatin daily for weeks and then titrated up to 40mg atorvastatin daily for an additional 12 weeks. Patient's inflammatory markers (ferritin, CRP) and weekly Epogen usage will be monitored.

Patients will be identified and consented. After informed consent is obtained, baseline demographic information, past medical history, dialysis specific information, and laboratory metrics (lipid profile, inflammatory markers) will be obtained from the electronic medical records. For the first 12 weeks, all subjects will be instructed to take one 20mg atorvastatin tablet daily; atorvastatin tablets will be dispensed by the research team in 30-tablet increments every month to ensure compliance and prevent diversion. Subjects will undergo standard-of-care hemodialysis with routine hemoglobin monitoring and Epogen titration according to the dialysis center protocol. Every two weeks, they will be assessed by a research coordinator who will monitor for medication adverse effects (see attached patient survey) and medication compliance (pill counts) at alternating visits. After 12 weeks, lipid profile and inflammatory markers will be rechecked or obtained from the electronic medical record. For the subsequent 12 weeks (ie. weeks 12-24), subjects will be instructed to take two 20mg atorvastatin tablets (40mg total) daily. If the subject is unable to tolerate 40mg of atorvastatin daily due to medication adverse effects, they will continue to take 20mg atorvastatin daily for the remainder of the trial. Epogen will be titrated and subjects will be monitored as above. At the completion of the study, a lipid panel and inflammatory markers will be checked for a third time. Epogen usage and dialysis specific information will be recorded continuously throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Stable on Hemoglobin levels on Epogen therapy (Hgb between 9.5-11.5 for prior 3 weeks)
* No statin usage during the prior 3 months
* Complaint with hemodialysis and medications

Exclusion Criteria:

* Prior history of myocardial infarction, stroke or vascular disease
* Prior hospitalization within the past 15 days
* Prior episodes of significant bleeding (trauma, GI bleed, GU bleed, menorrhagia) in the prior 15 days
* Liver disease
* Active malignancy
* Hematologic disorder
Study of Immunotherapy Combined With Chemotherapy in Locally Advanced and Metastatic Pancreatic Cancer

To evaluate the efficacy of PD-L1/CTLA4 BsAb for the second line treatment and the combination with chemotherapy for the first line treatment in pancreatic cancer

Subjects who signed the informed consent were assigned to three cohorts according to the actual treatment status. Cohort 1 enrolled subjects receiving PD-L1/CTLA4 BsAb 5mg/kg iv Q2W for 2nd treatment; cohort 2 enrolled subjects receiving PD-L1/CTLA4 BsAb in combination with gemcitabine/albumin- paclitaxel as 1st treatment for 4-6 cycles with PD-L1/CTLA4 BsAb monotherapy maintainence; cohort 3 enrolled subjects received systemic chemotherapy, receiving PD-L1/CTLA4 BsAb combined with oxaliplatin / irinotecan / leucovorin / fluorouracil (FOLFIRINOX) as 1st treatment for 4-6 cycles withPD-L1/CTLA4 BsAb monotherapy maintainence; until disease progression according to RECIST 1.1, intolerable toxicity, withdrawal, death, 2-yr treatment,who comes first.

Eligibility Criteria:
Inclusion Criteria:

* Histology or cytology confirmed as pancreatic ductal adenocarcinoma;
* ECOG 0-1;
* adequate organ function (absolute neutrophil count ≥1.5 x 109/L; platelet count ≥100 x 109/L; creatinine \< 1.5 x ULN (upper normal) or calculated creatinine clearance ( CRCI) ≥ 60mL/min; albumin ≥ 30g/L; total bilirubin \<1.5 x ULN; aspartate aminotransferase (AST) \< 2.5 x ULN; alanine aminotransferase (ALT) \< 2.5x ULN; INR or PT \< 1.5x ULN, and aPTT \<1.5x ULN);
* no obvious symptoms of jaundice and ascites;
* no other serious underlying diseases

Exclusion Criteria:

* patients with active brain metastases;
* history of autoimmune diseases, or need to be treated with corticosteroids and immunosuppressive agents;
* past history of unstable angina, symptomatic congestive heart failure, severe arrhythmia, myocardial infarction within 6 months, QT interval prolongation (\>450ms);
* other malignant tumors within the last 5 years;
* pregnant or lactating women;
* NRS ≥ 4 points;
* unintentional weight loss ≥ 5% within 1 month before the first dose even if peripheral or central vein nutrition support,
Effect of Child Preference for Parental Selection During Induction

Induction of anesthesia can be distressing both for children and their parents. Nonpharmacological behavioral interventions can reduce the anxiety of children without significant adverse effects as seen with sedative drugs. has not been documented.

The aim of this study will be to evaluate the effect of children's preference on parental selection during the induction of anesthesia on children and parental anxiety during the perioperative period.

Anesthetic induction can be one of the most stressful experiences for the child during the perioperative period, with almost 50% of the children showing significant anxiety. . To minimize the effect of anxiety, several methods have been adopted, such as the introduction of day-case surgery, parental presence at the induction of anesthesia, distractions and the use of pharmacological agents like midazolam to reduce anxiety.

Although the effect of parental presence on the anxiety of children and parents was studied in various studies. Whether the children's choice of parental selection affects anxiety is not studied yet. In this study, we will evaluate the anxiety of children by using mYPAS .

Eligibility Criteria:
Inclusion Criteria:

* 80 children of both sex, aged 4-15 years with ASA physical Status I-II will be enrolled

Exclusion Criteria:

1. Mentally challenged
2. Deaf Child
3. Cerebral Palsy
4. Premedicated Child
5. Language Problem
6. Unco-operative
7. Previous surgery or anesthesia history
Indirect Calorimetry: SensorMedics Vmax vs GE Carescape - a Method Comparison Study

Dosing of nutrition in PICUs is mainly based on patient weight and assumptions on clinical status. There is however poor correlation between these calculations and actual energy consumption measured with indirect calorimetry (IC). Available equipment for IC has however been too cumbersome to use in daily clinical practice. Of relative new date is IC integrated in modern ventilators. This functionality is easy to use, but we do not know if the results are reliable for children. This study is a method comparison study comparing measurements done with SensorMedics Vmax ("gold standard") vs GE Carescape (modern ventilator with Integrated IC) in children undergoing intensive care treatment.


Eligibility Criteria:
Inclusion Criteria:

* \< 18 years of age,
* endotracheally intubated.
* FiO2 \< 0,6, tube leak \< 10%, tidal volume \> 50 ml.

Exclusion Criteria:

* Ventilatory and hemodynamically unstable during 2 hours prior to inclusion.
Effect of Oxygen on Core Temperature

Study of the effect of oxygen on the frequency of central apnea, sleep and body temperature in patients with a cardiac disease


Eligibility Criteria:
Inclusion Criteria:

* Cardiac disease and Cheyne-Stokes respiration and controls without Cheyne-Stokes respiration

Exclusion Criteria:

* Obstructive sleep apnea
Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy

The purpose of this study is to compare the efficacy of allogeneic hematopoietic stem cell transplantation (allo-HSCT) from matched sibling donor (MSD),matched unrelated donor (MUD) and haploidentical related donors(HRD) in the treatment of hematologic malignancy.

Currently, allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only curative therapy for a majority of malignant hematologic diseases, especially acute leukemia. HSCT from MSD offers the best results for these diseases, but lack of this donor resource has restricted its wide application. HSCT from MUD provides another option, but MUDs still cannot satisfy all patients due to unsuccessful donor searches. Almost all patients have an available related donor with whom they share a single HLA haplotype (ie, haploidentical related donor), and it owns the advantage of immediate availability, especially for those who urgently need transplantation.The results of transplantation from HRD have improved significantly over the past few years. However, the results from such haploidentical transplantation have not formally been compared with those of transplantation in patients contemporaneously using MSDs and MUDs for hematologic malignancy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary disease is acute leukemia/MDS/CML
* Receiving allo-HSCT

Exclusion Criteria:

* cardiac dysfunction (particularly congestive heart failure)
* hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase\> 2 times the upper limit of normal)
* renal dysfunction (creatinine clearance rate \< 30 mL/min)
* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)
Mobile Technology and Motivational Interviewing in Type 2 Diabetes Patients

Type 2 diabetes patients were divided into experimental and control groups. Patients in the control group received regular nursing care, while those in the experimental group received MI, which is empowered by game-based mobile technology. Pre-test, post-test and follow-up test self-management, quality of life and satisfaction levels scores were determined.

A randomized controlled and experimental study design was used to conduct this research on 64 patients with Type 2 DM. Purpose of this study was to explore how motivational interviewing powered by game-based mobile technology affected self-management, quality of life, and satisfaction in Type 2 diabetes patients.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older,
* Having a diagnosis of Type 2 Diabetes Mellitus according to the ADA diagnostic criteria,
* Being on oral antidiabetic and/or insulin therapy,
* Having a smart phone and knowing how to use it,
* Internet connection (to install mobile technology application),
* Not having participated in motivational interviewing (MG) training before,
* Not having vision and hearing problems,
* Not having a communication problem,
* To be able to read, write and speak Turkish,
* Volunteering to participate in the study and continue the study process.

Exclusion Criteria:

* Having a diagnosis of Type 1 and/or Gestational Diabetes Mellitus,
* Having serious health problems that prevent participation in motivational interviewing,
* Using steroid therapy,
* Having complications that may develop in the long term due to diabetes and having advanced retinopathy, neuropathy, amputation history or active foot wound,
* Having mental confusion, having any psychiatric problems and/or using a psychiatric drug,
* Being unwilling to participate in the study and/or not wanting to continue the study process.
Gene Therapy Trial for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene

A clinical trial of AAV5-RPGR vector for participants with X-linked retinitis pigmentosa (XLRP)


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 3 years of age or older
* Has XLRP confirmed by a retinal specialist and has a predicted disease-causing sequence variant in RPGR confirmed by an accredited laboratory

Exclusion Criteria:

* Has had ocular surgery within 3 months prior to screening or is anticipated to require ocular surgery within 6 months after the study intervention administration
* Any investigational ocular treatment or any other ocular treatment that could confound the interpretation of the efficacy results or affect participant compliance with the visit schedule
* Has undergone prior retinal surgery involving the macula, macular laser photocoagulation, external-beam radiation therapy, transpupillary thermotherapy, glaucoma filtration surgery or corneal surgery
The Effect of Time-Restricted Eating in Cardiometabolic Health

Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-12 h/day with no energy intake the rest of the day. In rodents, TRE improves metabolic function without caloric restriction, potentially by activating nutrient sensing mechanisms and effects on circadian oscillations. However, an understanding of the effect of TRE on cardiometabolic health in people is not clear and few studies have evaluated this issue. Accordingly, the investigators propose to conduct a randomized controlled trial in people with obesity and prediabetes to determine the effect of 9 h TRE for 12 weeks, without a change in body weight, on key metabolic outcomes that are risk factors for cardiovascular disease (CVD): 1) multi-organ insulin sensitivity; 2) 24 h metabolic homeostasis and diurnal rhythm; and 3) adipose tissue and skeletal muscle biology. The proposed studies will elucidate the cardiometabolic implications of TRE in people with obesity and prediabetes.


Eligibility Criteria:
Inclusion Criteria:

* must be able to grant voluntary informed consent and comply with the study instructions
* aged 25-75 years
* men and women
* body mass index 27-45 kg/m2
* fasting plasma glucose 5.6-6.9 mmol/L, or 2h oral glucose tolerance test plasma glucose 7.8-11.1 mmol/L or haemoglobin A1C 39-46 mmol/mol or homeostasis model assessment-insulin resistance (HOMA-IR) score ≥2.73
* self-reported habitual eating period ≥ 13 h per day

Exclusion Criteria:

* shift worker
* fasting \>12 h/day more than once a week
* vegan
* \> once a week no food intake after \~1800 h
* habitually waking up before \~0400 h and sleeping before \~2100 h
* unstable weight (\>5% change the last 2 months)
* Clinical diagnosis of type 1 or 2 diabetes
* Clinical diagnosis of sleep disorder
* Clinical diagnosis of eating disorder
* Clinical diagnosis of cancer in last 5 years
* conditions that render subject unable to complete all testing procedures (including individuals with known allergies or contraindications to the medications used in this study)
* use of medications that affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued (e.g., steroids, alpha- or beta-adrenergic blockers or agonists, etc.)
* smoking and illegal drug use
* pregnant or lactating
* gastrointestinal or bariatric surgery (except cholecystectomy and appendectomy)
* individuals with electromedical devises
* prisoners
* alcohol abuse