cyrilzakka/clinical-trials huggingface dataset:
Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer

This study aims to explore the optimal number of cycles of PD-1 monotherapy required at minimum, under the premise of ensuring pathological complete response (pCR) among patients with dMMR/MSI-H rectal cancer.

Participants will receive preoperative monotherapy with PD-1 antibodies, with regular reassessments every 2 cycles. Surgical intervention will be performed if clinical complete response (cCR) is achieved.

Researchers will compare the pathological complete response rates, adverse reactions, and three-year event-free survival rates across different treatment cycles.


Eligibility Criteria:
Inclusion Criteria:

* 1.Age: 18 to 80 years old, male or female;
* 2.Patients with histologically or cytologically confirmed dMMR/MSI-H rectal adenocarcinoma, clinical stage II-III;
* 3.No prior systemic therapy, including chemotherapy, radiotherapy, immunotherapy, or targeted therapy;
* 4.ECOG Performance Status (PS) score of 0-1;
* 5.Estimated life expectancy of ≥ 3 months;
* 6.Normal function of major organs, with no severe abnormalities in blood, heart, lung, liver, kidney, bone marrow, or immunodeficiency. Laboratory tests must meet the following criteria: Hemoglobin (Hb) ≥ 90 g/L; White blood cell count (WBC) ≥ 3.0 × 10\^9/L; Neutrophil count (NEUT) ≥ 1.5 × 10\^9/L; Platelet count (PLT) ≥ 90 × 10\^9/L; Liver function (Aspartate Aminotransferase AST or Alanine Aminotransferase ALT) ≤ 2.5 times the upper limit of normal (ULN); Renal function (serum creatinine sCr) ≤ 1.5 times ULN; Total bilirubin (TBIL) ≤ 1.5 times ULN; Urine protein and occult blood \< 2+; Fecal occult blood \< 2+;
* 7.Subjects must voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up visits;
* 8.The investigator believes that the patient can benefit from the treatment. Physical status score PS ≤ 2;
* 9.Patients and their families must understand and be willing to participate in this study, providing written informed consent.

Exclusion Criteria:

* 1.Patients with a confirmed allergy to the investigational drug and/or its excipients;
* 2.Subjects who have received or are currently receiving additional chemotherapy, radiotherapy, targeted therapy, or immunotherapy;
* 3.Patients with any active autoimmune disease or a history of autoimmune disease;
* 4.Patients with Lynch syndrome;
* 5.Patients with poorly controlled cardiac symptoms or diseases, such as New York Heart Association (NYHA) Class II or higher heart failure, unstable angina pectoris, or myocardial infarction within the past year;
* 6.Pregnant or lactating women;
* 7.Patients with acute infections requiring antibiotic treatment;
* 8.Patients with positive hepatitis B or hepatitis C antibodies;
* 9.Patients with positive HIV antibodies;
* 10.Patients with other diseases that the investigating physician considers may affect prognosis and survival;
* 11.Any other conditions deemed inappropriate for participation in this study by the investigating physician.
Artificial Intelligence Identified Dyskalemia Using Electrocardiogram (AIDE)

This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of potassium abnormalities.


Eligibility Criteria:
Inclusion Criteria:

* Patients in emergency department.
* Patients recieved at least 1 ECG examination.

Exclusion Criteria:

* Patients recieved dyskalemia-related treatment before ECG examination.
* The patients recieved ECG at the period of inactive AI-ECG system.
Botulinum Toxin in Patients With Spastic Lower Limb Paresis Associated With Multiple Sclerosis

Spastic paraparesis is one of the most disabling functional deficits in the population with multiple sclerosis between 18 and 80 years of age and at any functional level. Infiltration with Botulinum Toxin is a clinical practice that has been carried out for years with clinical evidence of improvement in the patient's walking patterns and quality of life. We assume that the infiltration of this product can generate a direct benefit in the walking ability of these patients and secondarily improve their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Acceptance and signature of informed consent.
* Age between 18 and 80 years old, both included.
* Patients with relapsing remitting multiple sclerosis (RRMS), progressive secondary (SP) and primary progressive (PP), with spasticity resistant to usual treatment, either because of the severity of the spasticity or because of intolerance to side effects.
* Outpatients with spastic paraparesis that causes gait deficiency.
* Patients with an EDSS score between 2 and 6, both included.
* Patients with segmental involvement in MAS \>1 in two or more muscle groups in the lower extremities.
* Absence of cognitive disability. Score less than 5 on the SPMSQ scale of Pfeiffer.
* Possibility of carrying out the treatment (method of administration, scheduled visits) and scales correctly.
* Women of childbearing potential should use an effective contraceptive method (hormonal contraceptives, intrauterine device, condom) or refrain from having sex in order not to get pregnant. A woman is considered to be fertile after menarche and to become postmenopausal, unless she has undergone a permanent sterilization procedure (hysterectomy, salpingectomy, bilateral oophorectomy). A postmenopausal state is defined as absence of menstruation for 12 months without an alternative medical cause.

Exclusion Criteria:

* Psychiatric illness that hinders participation in the trial.
* Comorbidity that threatens the patient's life in the short term (severe liver disease, cardiovascular disease, etc.).
* Osteoarticular disorder that prevents physical activity.
* Pregnancy or lactation.
* Lack of primary or secondary response to any type of Botulinum Toxin for the treatment of MS previously detected.
* Sensitivity to Botulinum Toxin or to any excipient.
* Any medical condition that, in the opinion of the investigator, may compromise compliance with the objectives and / or procedures of this protocol or preclude the administration of Botulinum Toxin.
* Changes in the treatment regimen of any drug that directly or indirectly interferes with neuromuscular function within 4 weeks before the start of the study treatment.
Clinical Outcomes of Edwards Lifesciences MITRIS RESLILA Mitral Valve in the Asian Population

The purpose of this study is to evaluate the early and mid-term safety and performance of the MITRIS RESILIA mitral valve in Asian patients in a real-world setting

This study is a prospective, investigator-Investigator initiated, multicenter observational study that aims to competitively register 200 patients who have undergone mitral valve replacement surgery with the MITRIS RESILIA mitral valve at participating institutions to collect real clinical outcomes.

This study will collect data on clinical outcomes obtained during standard care for patients who undergo mitral valve replacement surgery using the MITRIS RESILIA mitral valve in South Korea.

The aim is to recruit 200 patients using the MITRIS RESILIA mitral valve (competitive recruitment, no more than 100 per institution) over a period of two years.

All patients registered in the registry will be followed for five years. Follow-up assessments will occur at 6 months, 1 year, 2 years, 3 years, and 5 years post-surgery. Including the 2-year registration period and 5 years of follow-up for result analysis, the total study duration is expected to be approximately 7.5 years. However, the overall duration may vary depending on the rate of participant registration.

Eligibility Criteria:
Inclusion Criteria:

1. Age 19 or older
2. Requires mitral valve replacement due to mitral valve dysfunction
3. The participant or their guardian can provide a written consent form approved by the IRB and agree to the research protocol and clinical follow-up schedule.

Exclusion Criteria:

1. Life expectancy of less than one year due to causes other than cardiovascular disease
2. High-risk candidates for mitral valve replacement: Society of Thoracic Surgeons Predicted Risk of Mortality 10% or greater; EuroSCORE 10% or greater; estimated surgical mortality rate by the surgeon 10% or greater
3. Chronic kidney disease: eGFR \<30 mL/min/1.73m²
4. Undergoing surgery for infective endocarditis
Compassionate Use of Deferiprone in Patients With PKAN

Patients with pantothenate kinase-associated neurodegeneration (PKAN) who have completed the ApoPharma-sponsored study TIRCON2012V1-EXT and who wish to continue to take deferiprone will be offered the opportunity to receive it on a compassionate basis. Patients will be followed locally by their own neurologist or other appropriate specialist.

Patients with PKAN who have completed both the randomized, blinded, placebo-controlled trial TIRCON2012V1 and its follow-up, the single-arm open-label extension study TIRCON2012V1-EXT, may enroll in this compassionate-use/expanded access program in order to continue receiving the iron chelator deferiprone. Participants in this program will be followed locally by their own neurologist or other appropriate specialist. Patients will take deferiprone oral solution 80 mg/mL at the same dose they were prescribed in the TIRCON2012V1-EXT clinical trial. Safety monitoring of the patients will be performed. At a minimum, the program will continue until the analysis of the currently blinded TIRCON2012V1 trial is completed (approximately Q4 2016), at which time it will be re-evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Completed study TIRCON2012V1-EXT
2. Able to adhere to program appointments and evaluation schedules
3. Females of childbearing potential must have a negative pregnancy test result at the start of the program, unless the treating physician determines there is no reasonable risk of pregnancy because of significant incapacity. If applicable, they must meet at least one of the following criteria: Use an effective method of contraception during the program and for 30 days following the last dose of deferiprone, OR participate in a non-heterosexual lifestyle, OR have a male sexual partner who has been sterilized, OR be abstinent during the program and for at least 30 days after its completion.
4. Fertile sexually active heterosexual males must agree to use an effective method of contraception during the program and for at least 30 days after its completion
5. Patients and/or their authorized legal representatives must provide signed and dated written informed consent, and minors must additionally sign an assent form as per local regulatory requirements.

Exclusion Criteria:

Patients will be excluded from taking part in the compassionate use program if the treating physician determines the presence of any medical, psychological, or psychiatric condition which in his/her opinion would cause participation in the program to be unwise
SCRT(Short Course Radiotherapy) Combined With CAPOX Plus QL1706 for Rectal Cancer Liver Metastases

To enhance the treatment efficacy of rectal cancer liver metastasis through a multidisciplinary approach of radiotherapy, immunotherapy, and chemotherapy, and to provide a new direction for the combination treatment strategy.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years, any gender.
2. Pathologically confirmed rectal cancer with liver metastases (stage M1).
3. Karnofsky Performance Status ≥70.
4. Adequate organ function, no contraindications to radiotherapy, or immunotherapy.
5. Microsatellite/mismatch repair status MSS/pMMR.
6. No prior chemotherapy or any other anti-tumor treatment before inclusion.
7. No prior immunotherapy.
8. Ability to comply with the study protocol during the study period.
9. Signed written informed consent.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Pathological diagnosis of signet ring cell carcinoma.
3. History of other malignancies within the past 5 years, except cured skin cancer and cervical carcinoma in situ.
4. Uncontrolled epilepsy, central nervous system disorders, or history of psychiatric disorders that, in the opinion of the investigator, may interfere with signing the informed consent form or affect patient compliance with oral medication.
5. Clinically significant (i.e., active) cardiac disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or greater congestive heart failure, or significant arrhythmias requiring drug intervention (see Appendix 12), or history of myocardial infarction within the past 12 months.
6. Organ transplant recipients requiring immunosuppressive therapy and long-term steroid users.
7. Patients with autoimmune diseases.
8. Severe uncontrolled recurrent infections or other severe uncontrolled comorbidities.
9. Subjects with baseline hematological and biochemical parameters not meeting the following criteria: hemoglobin ≥90g/L; absolute neutrophil count (ANC) .≥1.5×10\^9/L; platelets ≥100×10\^9/L; ALT, AST ≤2.5 times the upper limit of normal; ALP ≤2.5 times the upper limit of normal; serum total bilirubin \<1.5 times the upper limit of normal; serum creatinine \<1 times the upper limit of normal; serum albumin ≥30g/L.
10. Known deficiency of dihydropyrimidine dehydrogenase (DPD).
11. Allergy to any investigational drug components.
Pathophysiological Basis of Hidradenitis Suppurativa

HS is a chronic inflammatory disease manifested by recurrent inflammatory nodules, abscesses and tunnels under the skin. This disease is characterized by an inflammatory process that takes place in hair follicles, sebaceous glands and surrounding tissue. Because of its frequent recurrence and chronicity, it represents a major public health problem and there is a need for better diagnosis and new and more effective drugs. This research can be a part of realizing the stated needs.

HS patients, divided into three groups depending on the stage of hidradenitis, would participate in the study.

The first and second groups would include stage 2-3 patients (according to the Hurley scale) in whom partial or complete clinical remission occurred after biological therapy and surgical treatment was performed according to the guidelines.

In the third (control) group, we would classify the samples obtained from the above-mentioned patients, from whom we would take a sample of "normal" skin measuring 1 x 1 cm.

With the standard procedure of pathohistological tissue processing after tissue fixation with 10% buffered formalin and embedding in paraffin, tissue sections stained with standard hematoxylin and eosin (HE) staining will be analyzed using a light microscope in such a way as to determine the type and amount of inflammatory infiltrate, the amount of granulation tissue and fibrosis and epithelial changes of the surface and follicular epithelium and graded according to intensity into 3 categories.

The mentioned tissue samples fixed in formalin and embedded in paraffin will be used to make tissue sections for immunohistochemical staining. The expression of inflammatory cytokines will be analyzed using the indirect peroxidase immunohistochemical method. Primary and secondary antibodies will be used for immunohistochemical analyses. The prepared tissue sections will be deparaffinized in a xylene solution and then dehydrated in a series of ethyl alcohols of decreasing concentrations (100%, 96% and 75%). It will then be washed three times with PBS solution and in citrate buffer (10mM, pH 6.0). Sections will then be washed with Triton X 100 solution (0.3% in PBS) at room temperature. After that, endogenous peroxidase will be inactivated using hydrogen peroxide in methanol (0.3%) for 30 minutes. After washing the tissue sections with PBS solution, normal serum (10%) will be added for 60 minutes. After washing the tissue sections in PBS solution (pH 7.4), the secondary antibody will be added depending on the primary one. Tissue rehydration will be done in ethyl alcohols of increasing concentrations (75%, 96% and 100%). After clarification with xylol, the preparation will be incorporated into entalan.

The intensity of immunohistochemical staining will be analyzed using the ImageJ computer program according to the staining intensity.

Eligibility Criteria:
Inclusion Criteria:

* Hidradenitis Suppurativa

Exclusion Criteria:

* patients with no HS
* patients who do not want to be in the clinical trial
New Disposable Contact Lens Patient Interface For The Lensx Laser

The objective of this study is to evaluate the ease of use of a modified, disposable contact lens and suction ring assembly.

This will be a prospective, single center clinical trial of up to 300 consecutive eyes of subjects scheduled to undergo ocular surgery requiring an initial incision, specifically, cataract surgery. Subjects will be screened for eligibility. Eligible subjects will be examined preoperatively to establish a baseline for ocular condition.

Subjects will undergo unilateral cataract surgery using the LenSx Laser for one or a combination of the following laser procedures: anterior capsulotomy, laser lens phacofragmentation and corneal incision with implantation of an intraocular lens (IOL). Surgeon and staff comments will be solicited for ergonomic and packaging features of the new disposable contact lens. Subjects will be evaluated intraoperatively to assess comfort of the new disposable contact lens, as well as the completion of anterior capsulotomy, laser lens phacofragmentation and completion of corneal incisions. All patients will be evaluated postoperatively at one day, one week and 1 month to follow the condition of the surgical eye. Further follow up can be performed at the discretion of the surgeon.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation in at least 1 eye.
2. Subjects must be at least 24 years of age.
3. Subjects must be willing and able to return for scheduled follow-up examinations.
4. Subjects must sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

1. Subjects with corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light are excluded.
2. Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally are excluded.
3. Subjects with residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease) in either eye are excluded.
4. Subjects with a history of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP\>21 mm Hg in either eye are excluded.
5. Subjects with known lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
6. Subjects who have undergone previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye are excluded.
7. Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study are excluded.
8. Subjects with known sensitivity to planned study concomitant medications are excluded.
9. Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation are excluded
10. Subjects presenting any contraindications to cataract surgery are excluded.
18F-NaF Uptake and Aortic Stenosis Progression

This study aims to evaluate whether baseline 18F-sodium fluoride uptake activity at aortic valve could predict aortic stenosis progression in moderate aortic stenosis.

Patients with moderate aortic stenosis are enrolled and underwent baseline evaluation including 18F-sodium fluoride PET/CT. After 1 year, all the participants underwent follow-up echocardiography. The study design is an observational trial. Primary endpoint was a change in mean pressure gradient along the aortic valve as assessed by echocardiography at 1 year. Secondary endpoints include changes in aortic valve area, and symptom occurrence.

Recent studies demonstrated 18F-sodium fluoride (NaF) uptake activity as a marker of early-stage calcification. Although valve calcification could be visualized either by echocardiography or coronary computed tomography, they only reflect the current burden of calcium deposit not the activity of calcium deposit. Limited studies exist regarding the usefulness of 18F-NaF uptake at aortic valve for prediction of stenosis progression.

Patients with moderate aortic stenosis - diagnosed by echocardiography - will be enrolled. Enrolled participants will undergo baseline 18F-NaF PET/CT within 6 weeks of baseline echocardiography and followed up for 1 year. After 1 year, all the participants are required to evaluate the aortic stenosis progression by performing echocardiography.

The objective of the study is to test whether baseline 18F-NaF uptake activity predict AS progression.

Eligibility Criteria:
Inclusion Criteria:

* over 20 years old
* moderate aortic stenosis

Exclusion Criteria:

* age \< 20 yrs
* pregnant women
Investigation of Vascular Relaxing Effects of the Antidiabetic Rosiglitazone.

The study is designed to test the hypothesis in healthy subjects that the oral antidiabetic drug rosiglitazone provides additional vascular relaxing or modulating effects in addition to its blood glucose level reducing ability.

The aim of the study is to investigate the effect of oral rosiglitazone therapy on the vascular responsiveness of different vasoactive compounds (angiotensin II, insulin, histamine and glyceroltrinitrate) in healthy subjects. Rosiglitazone will be given orally (4 weeks 4mg/d, titrated to 8 mg/d for another 4 weeks) as treatment. Every subject will receive intravenous stimulation with angiotensin II, histamine, insulin and glyceroltrinitrate before and after an 8 weeks treatment interval with rosiglitazone.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Healthy
* 18 - 40 years old
* Non-smoker
* No additional medication

Exclusion Criteria:

* Any relevant disease
* Smokers
* Elevated liver enzymes
* Body weight different from Broca norm \> 20%
* Allergies