cyrilzakka/clinical-trials huggingface dataset:
Cell Therapy with Treg Cells Obtained from Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children

The investigators developed a protocol to isolate Treg cells from thymic tissue (thyTreg) discarded in pediatric cardiac surgeries. After completing the pre-clinical studies, the investigators have initiated a phase I/II clinical trial to test the safety and efficacy of the adoptive transfer of autologous thyTreg to prevent rejection in heart transplant children.

Condition or disease: Heart Transplantation Intervention/treatment: Regulatory T Cell (Treg) Infusion

Current transplant practice is far from guaranteeing the life expectancy of patients, particularly if the patients are children. THYTECH aims to revolutionize the field of clinical immunology developing a new approach to govern the regulatory skills of immune system, preventing graft rejection and opening a new frontier in the treatment of immune diseases.

Transfer of regulatory T cells (Treg) has acquired growing interest in the race to achieve indefinite transplant survival. Up to now, the use of Treg therapy to prevent solid graft rejection in humans has demonstrated that this therapy is safe, but the clinical efficacy is limited. The small Treg numbers that can be purified from peripheral blood along with the low survival and limited suppressive capacity of differentiated Tregs obtained from adults have probably compromised the efficacy of this therapy.

The investigators have developed an innovative approach to overcome current barriers and make Treg transfer a reality equipped to achieve indefinite graft survival. The major innovation of THYTECH is the employment of thymic tissue, the site of Treg generation, as a new source of Tregs to obtain massive amounts of thymus-derived Tregs (thyTreg) with very high purity (\>95% of CD 25+ Foxp3+ cells) and improved survival and suppressive capacities. The investigators are recruiting patients in a clinical trial transferring autologous Tregs in heart-transplanted children to prevent graft rejection.

Eligibility Criteria:
Inclusion Criteria:

1. Patient under two years of age, who meets all the necessary requirements to undergo a heart transplant.
2. Patients without contraindication to immunosuppressive drugs.
3. Parents and/or guardians must be willing and able to understand the purpose and risks of the study and must sign the informed consent document

Exclusion Criteria:

1. Patients with DiGeorge Syndrome, since their thymic function is affected.
2. Human immunodeficiency virus positive serology
3. Epstein-Barr virus active infection
4. Patients hyperimmunized with cytotoxic anti-human leukocyte antigen antibodies
5. Patients with a history of previous malignancy
6. Patients who have participated in other intervention studies in the last month.
7. Patients who have received induction therapy with Basiliximab or Thymoglobulin.
8. Patients who have previously been thymectomized or transplanted.
9. Patients who have been diagnosed with severe autoimmune disease (celiac disease, autoimmune hypothyroidism, autoimmune diabetes)
10. Patients who will receive an asystole heart
A Study to Compare the Pharmacokinetic Characteristics of CJ-12420

To compare the pharmacokinetics after administration of different formulation of CJ-12420

The purpose of this study is to compare the pharmacokinetics after a single dose administration of CJ-12420 formulation 1 and formulation 2.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male aged 19 to 45 years at the screening
* Subject who is over 50kg with BMI between 19 kg/m2 to 28 kg/m2 (inclusive)
* Subject who fully understood after being informed detailed description of clinical trial, written informed consent voluntarily to observe the precautions.

Exclusion Criteria:

* Subject who fall under the criteria below in laboratory test.

  * AST, ALT, ALP, GGT, total bilirubin, BUN, creatinine \> UNL x 1.5
* Subject who with low blood pressure with clinical significance at screening test.

  * (systolic blood pressure is less than 90 mmHg or over 140 mmHg, and diastolic blood pressure is less than 50 mmHg or over 90 mmHg)
* Subject who has a medical history of symptomatic GERD, erosive esophagitis or duodenal ulcer, gastric ulcer, barrett's esophagus or zollinger-ellison syndrome.
Frequency and Presentations of Chronic Pain Following Breast Cancer Surgery: An Observational Study in a Tertiary Care Hospital of Pakistan

This study is designed to evaluate the frequency and presentations of chronic persistent pain in patients after breast cancer surgery at our tertiary care hospital. Results of this study will help us to understand the magnitude of problem in our population and making institutional guidelines for appropriate management of such patients.

After approval from the Departmental Research Committee and Institutional Ethical Review Committee all adult female patients with known carcinoma of breast who are scheduled for elective definitive breast cancer surgery (Mastectomy) from 1st July 2016 to 30th December 2016 will be enrolled in this audit. Inclusion of patients will be done once operative procedure is finalized and consent taken in breast clinic. Those patients who did not give consent and those patients who need reoperation on same side for recurrence of cancer or any reason will be excluded from this study.

Data will be obtained from patient's medical record, interview of patient on follow up visit at breast clinic and telephonic communication with patient. Variables have been defined and a special form has been designed for data collection. All patients will be followed for next three months and those who have persistent pain will be followed for six months after operation.

Follow up information will be obtained from patient visiting breast clinic. For any missing data patient's medical records will be reviewed and patient will be contacted to know if they have chronic post-surgical pain or not. Audit forms will be filled by authors according to their availability. The primary investigator or author at breast clinic will keep all forms for safe record keeping which shall later be used for data analysis.

Eligibility Criteria:
Inclusion Criteria:

* all adult female patients with known carcinoma of breast who are scheduled for elective definitive breast cancer surgery (Mastectomy)

Exclusion Criteria:

* Those patients who did not give consent and those patients who need reoperation on same side for recurrence of cancer or any reason will be excluded from this study.
Efficacy Study on Dimethyl Fumarate to Treat Moderate to Severe Plaque Psoriasis

This multicenter, randomised, double-dummy, Fumaderm® and placebo-controlled, parallel-group study will compare the efficacy and safety of 500 mg of FP187 (250 mg twice daily) compared to 720 mg Fumaderm® (240 mg three times daily) over 20 weeks of treatment. After an initial wash-out non-drug treatment phase of 1 to 6 weeks, all patients will receive allocated Study treatment up-titrated to the relevant dose level (i.e., 500 mg daily FP187, 720 mg daily Fumaderm®, or placebo). The up-titration to full dose will last 4 weeks for FP187 and 9 weeks for Fumaderm®. After 20 weeks of treatment, all patients will be asked to enter a separate open label treatment protocol expected to continue for up to 5 years.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* clinical diagnosis of stable moderate to severe plaque psoriasis for at least 6 months;
* clinical diagnosis of plaque psoriasis with an affected body surface area of no less than 10% and least 10 on the PASI scale and on the sPGA score at least as moderate;
* Besides psoriasis, patient is in good general health
* Patients with a DLQI score of at least 10

Exclusion Criteria:

* Pustular forms of psoriasis, erythrodermic or guttate psoriasis;
* Known immunosuppressive diseases;
* Presence of another serious or progressive disease including skin malignancies;
* Active skin disease;
* Use of topical medical treatment or UVB treatment during the 2 weeks preceding randomization;
* Use of systemic anti-psoriatic treatment preceding randomization: methotrexate, cyclosporine, steroids or PUVA (psoralen + UVA treatment) treatment within 4 weeks; biological treatment within 12 weeks; Stelara within 20 weeks; acitretin within 6 months;
* Treatment with Fumaderm® or other Dimethyl Fumarate containing products within 12 weeks prior randomization;
* Treatment with drugs influencing the course of psoriasis (e.g., antimalarial drugs, lithium) within 4 weeks prior to randomization;
* Treatment with retinoids, other immunosuppressive treatment, cytostatics or drugs with known harmful effects on the kidneys within 3 months prior to randomization;
* On-going stomach or intestinal problems;
* Aspartate transaminase (AST), Alanine transaminase (ALT) \> 2 x upper normal limit (ULN), or Gamma-glutamyltransferase (γ-GT) \> 2.5 x ULN;
* Creatinine Clearance \< 60 ml/min;
* Leucopenia, eosinophilia or lymphopenia;
* Protein in the urine test;
Selinexor and HAAG With/Without HMA in Relapsed/Refractory Acute Leukemia (AML) Patients

The purpose of this study is to evaluate the efficacy and safety of selinexor and HAAG +/- HMA in relapsed/refractory acute leukemia (AML) patients.

This protocol corresponds to a single-center, open-label, single-arm, exploratory study designed to determine the efficacy and safety of the combination of selinexor with HAAG +/- HMA in patients with relapsed or refractory AML. The patients who respond to this combination treatment will undergo allogeneic hematopoietic stem cell transplantation and post-transplantation maintenance treatment according to patient's wishes.

Each cycle of treatment will compromise 2 weeks of selinexor treatment, and at least two weeks off treatment. The new cycle will not start if there is an ongoing grade 3 or higher non-hematologic toxicity or persistent grade 3 neutropenia in patients achieving CR.

Study design allows 20 patients. Treatment will consist of selinexor 60 mg/day orally on d1,4,8,11, HHT 1 mg/day intravenously on days 3 to 9, cytarabine 10 mg/m2 q12h, intravenously on days 3 to 9, aclacinomycin 10 mg/day intravenously on days 3 to 6, G-CSF 50-600 mcg/m2/day intravenously from days 2 to start, this dosage will be adjusted according to the hemogram, DAC 20 mg/m2/day intravenously on days 1 to 5. Whether to add hypomethylating agents was decided by the investigator according to the patient's disease degree and tolerance status. If patients had previously been exposed to decitabine, azacitidine will added this regimen, AZA 20 mg/m2/day subcutaneously on days 1 to 7.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged ≥18 years.
2. Diagnosis of AML (defined according to the 5th of the World Health Organization \[WHO\] 2022 criteria) of any type except for acute promyelocytic leukemia (APL; AML M3)and the following conditions were met: Relapsing or refractory AML
3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
4. Female patients of child-bearing potential must have a negative serum pregnancy test at screening and agree to use two reliable methods of contraception for six months after their last dose of medication.
5. Patients whose expecting survival time will be more than 3 months.
6. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.

Exclusion Criteria:

1. AML transformed from chronic myeloid leukemia.
2. Patients with APL/AML M3.
3. Presence of CNS leukemia.
4. Uncontrolled infection or other serious disease.
5. Unstable cardiovascular function: Cardiac ejection fraction (EF)\<0.5, or congestive heart failure (CHF) of NYHA Class ≥ 2.
6. Unstable Liver and kidney function:TBLL≥2.0 mg/dl, AST≥3×ULN, Ccr≥50 ml/min, SpO2\<92%.
7. Known human immunodeficiency virus (HIV) infection.
8. Active hepatitis B or hepatitis C infection.
9. Pregnant and lactating women. Patients with other commodities that the investigators considered not suitable for the enrollment.
Coronavirus Infection (COVID-19) and Radical Surgery in Patients With Early-stage Lung Cancer

The goal of this observational study is to learn about the effects of coronavirus infection in patients with early-stage lung cancer. The main question it aims to answer is whether the interval of surgery and COVID-19 infection will affect the surgery and prognosis of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed stage I and stage II lung cancer, who are about to receive wedge resection, segmental resection, sleeve resection, lobectomy, or pneumonectomy under general anaesthesia.
* Volunteer to participate in the study with good compliance. Able to complete the observation and follow-up and have signed the informed consent.
* ASA score: I-III;
* Cardiopulmonary functions meet the requirements of radical operation for lung cancer with normal liver and kidney functions.

Exclusion Criteria:

* Neurologic, mental illness or mental disorder which is hard to control, poor compliance, unable to cooperate or describe the treatment response;
* Clinically diagnosed stage III and stage IV lung cancer or patients who received neoadjuvant treatment before surgery;
* Patients developed symptoms alike coronavirus infection but are not confirmed by viral RNA detection by quantitative RT-PCR or antigen testing kits.
* Serious heart, lung, liver and kidney dysfunction and unable to tolerate the operation
Head-mounted Display for Central Venous Catheterization

Head-mounted displays (HMD) in medical practice are current research topics. The goal of this clinical trial is to learn if HMD would improve the safety and efficacy in ultrasound-guided central venous catheterization. The main questions it aims to answer are: Does HMD reduce the procedure time and increase the catheterization success rate in ultrasound-guided central venous catheterization. Does HMD increase the satisfaction score of operators and patients. Researchers will compare HMD with the conventional ultrasound in central venous catheterization. Operators will receive either HMD or conventional ultrasound machine to guide internal jugular vein catheterization. The procedure time, puncture success rate, complication and satisfactory score will be recorded.


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for elective surgery under general anesthesia
2. Patients indicative of internal jugular vein catheterization.

Exclusion Criteria:

1. A recent history of internal jugular vein puncture, wound, infection, hematomas, nerve injury at the venous cannulation site; 2. Combined with peripheral vascular disease, coagulopathy; 3. History of opiate abuse; 4. Pre-existing chronic pain, mental or neurological disorders; 5. Allergy to local anesthetics or gel; 6. Unstable vital signs, including hypertension, hypotension or arrhythmia
A Study of Ibandronate (Bondronat) in Participants With Metastatic Bone Disease

This study will evaluate the efficacy, safety, and effect on quality of life of oral ibandronate (Bondronat) in participants with breast cancer and metastatic bone disease. The anticipated time on study treatment is 25 weeks, and the target sample size is 50 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Females at least 18 years of age
* Breast cancer
* Bone metastases

Exclusion Criteria:

* Use of bisphosphonates within the last 3 months
* Prior use of gallium nitrate or metastron
* Severely impaired renal function
* Hypocalcemia or primary hyperparathyroidism
* Central nervous system (CNS) metastases
Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension

This study compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an investigator masked randomization process, each subject is allocated to recieve either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjuctive to a prostoglandin analogue for a period of 12 weeks. After screening, patient returns at baseline, Month 1, and Month 3 for ophthalmic evaluations.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 yrs.
* Female subjects of childbearing potential must have negative pregnancy test and provide contraception.
* Subjects must have confirmed diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes.
* Subjects who are or have been insufficiently responsive to IOP reducing monotherapy and use of either study medication is deemed appropriate.
* Subjects able to complete questionnaires and provide informed consent.

Exclusion Criteria:

* Female subjects who are pregnant, planning to become pregnant during study period, breast feeding or not practicing a reliable method of birth control.
* Subjects wherein the study drugs are containdicated.
* Subjects who have had introcular surgery with 6 months (3 months for laser).
* Subjects with known side effects/ allergy or sensitivity to any component of study treatments.
* Subjects with any uncontrolled systemic disease.
A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)

This is a study in participants with Exocrine Pancreatic Insufficiency (EPI) due to pancreatic cancer. This study will include resected participants who are post pancreatic cancer surgery, and an additional cohort in non-resected participants.


Eligibility Criteria:
Inclusion Criteria:

* Participant has diagnosed cancer of pancreas with biopsy and/or radiography, with a life expectancy of at least 5 months at screening
* Participant's pancreatic cancer must involve the head and/or neck of the pancreas
* Confirmed exocrine pancreatic insufficiency (EPI) as evidenced by fecal elastase-1 (FE-1) ≤ 150 µg/g stool at screening
* A positive Sudan stain for participants without history of fat malabsorption (fat malabsorption is defined as clinical steatorrhea, or measured stool fat \> 7 g/day, or positive stool results by Sudan stain) within 1 week of screening -- Positive stool results are defined as increased level of neutral OR total fats

Exclusion Criteria:

* Participant has neuroendocrine pancreatic cancer
* Participant has fibrosing colonopathy
* Participant has any other malignancy within 1 year of screening
* Participant has uncontrolled gout, including those with a recent flare within 60 days of screening
* Participant has other significant organ or bone marrow abnormality within 60 days of screening
Study of Coronary Heart Disease (CHD) & Heart Failure (HF) Risk in Prostate Cancer Patients, Taking Casodex or Not

A retrospective cohort study performed in the GPRD,UK. All patients with incident prostate cancer identified between 1 Jan 1999 and 31 Dec 2005 and a frequency-matched cohort of the general population will be followed- up for two outcomes; CHD including acute myocardial infarction or death from coronary heart disease and HF until Dec 31, 2006. Outcomes will be validated through requests to primary care physicians. Incidence rate´ratios of CHD and HF in the two cohorts will be calculated. In the cohort of prostate cancer the relative risk of CHD and HF associated with the use of bicalutamide compared to non-use will be estimated.


Eligibility Criteria:
Inclusion Criteria:

* At least two years enrollment with the general practitioner

Exclusion Criteria:

* Patients with cancer before start date of the study
Impact of Enhanced External Counterpulsation on Vascular Hemodynamics and Status

The present study aimed to investigated the effect of Enhanced External Counterpulsation (EECP) on vascular hemodynamics and atherosclerosis, and the underlying shear stress related mechanisms

Patients with coronary heart disease will be randomized into two groups: standard medical treatment and standard medical treatment plus EECP intervention. Hemodynamic parameters, vascular status and function will be measured.

Eligibility Criteria:
Inclusion Criteria:

* More than 50% stenosis of left main trunk and 3 epicardial coronary arteries and their large branches showed by coronary angiography
* Or history of myocardial infarction
* Or history of prior revascularization
* Signed informed consent to participate in the study

Exclusion Criteria:

* Clinically significant valvular heart disease
* Aortic aneurysm
* Congenital heart disease
* Acute myocarditis
* Arrythmias significantly interfere with the triggering of the EECP device
* History of cerebral hemorrhage
* Hemorrhagic disease
* Lower limb infection, phlebitis
* Deep venous thrombosis
* Malignant disease
* INR \> 2.5
* Uncontrolled hypertension, defined as SBP \> 180mmHg or DBP \> 110mmHg
* Pregnancy
Circulating microRNAs for Discriminating Obese Preschoolers at Risk of Diabetes

Childhood obesity certainly increases susceptibility to type 2 diabetes (T2D) in adulthood. Recently, microRNAs (miRNAs) are closely related to various diseases and have been suggested as valuable biomarkers. Here, we sought to identify potential miRNAs to discriminate obese children at risk for diabetes in future.

This study was designed to screen the circulating miRNAs in association with progression from children obesity to type 2 diabetes (T2D) in adulthood. Serum samples were evaluated in a 3 step procedure: 1) discovery study, in which samples from obese children and healthy controls were pooled for miRNA sequecing experiment; 2) cross-sectional validation study, in which miRNAs of interest were validated in all individuals (obese children, overweight children and normal controls); 3) longitudinal validation study, in which the candidate miRNAs were estimated in newly diagnosed diabetes patients and normal glucose tolerance controls (NGT). The final determined miRNAs were further confirmed though primary function studies.

Eligibility Criteria:
Inclusion Criteria:

Obese preschoolers; Adults with type 2 diabetes; Age-matched healthy controls.

Exclusion Criteria:

-