cyrilzakka/clinical-trials huggingface dataset:
Patient-centered Dosage of Levothyroxine

Levothyroxine is the most used thyroid hormone replacement when the thyroid gland is failing. Because dosage adjustment normally takes several months, the investigators have developed a decision support tool (DST) that predicts optimal dosage based on repeated blood samples the first 2 weeks after initiation of therapy. In this randomized study the investigators will include patients that start levothyroxine therapy after total thyroidectomy. The use of DST to advice the physician about an early dosage adjustment will be compared with common clinical practice, that is dosage adjustment every 2 months. The effect of DST use will be assessed by studying the possible relationship between fast optimal dose adjustment, patient reported outcome measures, and ability to work.


Eligibility Criteria:
Inclusion Criteria:

* Total or completion thyroidectomy for differentiated thyroid cancer og benign thyroid nodules at Norwegian hospitals

Exclusion Criteria:

* Anaplastic thyroid cancer, thyroid cancer with distant metastasis, graves disease, toxic nodules, pregnancy
Improve Nuclear Medicine Heart Imaging, Compare MRI Results With Single Photon Emission Computed Tomography Imaging

The purpose of this study is to compare the MRI results with the new SPECT image reconstruction method, this study will allow us to determine whether a new more accurate method of looking at the heart by nuclear study can be used in routine clinical use.

Currently, up to one-third of all nuclear medicine studies are performed for cardiovascular disorders, and mostly are myocardial perfusion imaging (MPI) using SPECT acquisition. MPI aims at detection of acute myocardial ischemia and the scarred myocardium and it is increasingly used to plan myocardial revascularization and to assess the effectiveness of medical and surgical interventions. However, nonuniform gamma-ray attenuation in the thoracic region may severely impair the accuracy of SPECT cardiac imaging and frequently result in image artifacts. Therefore, attenuation corrected must be applied. We have derived an algorithm (called EM-IntraSPECT) that is able to reconstruct tomographic cross-sections of a patient from SPECT studies alone. The reconstructed cross-sections in turn, may be used for attenuation correction of cardiac SPECT images thus improving quality analysis based of these images. In this research we intend to continue evaluation of the new attenuation compensation algorithm and to assess the clinical usefulness of this method. These goals can be reached by comparing the patient's cross sectional anatomical data reconstructed by EM-IntraSPECT and obtained from MRI. It is proposed that 10 patients already undergoing nuclear cardiac imaging for clinical purpose, with 99mTc sestamibi or 99mTc radiolabeled red cells will be selected. These patients would be utilized to reconstruct transmission images and determination of internal anatomical structures in the thoracic region from SPECT projections alone. Further, direct and quantitative comparison of the patient's anatomy obtained by the MRI and the SPECT methods will be performed. The same algorithm would be used for reconstruction of attenuation compensated emission SPECT cardiac images. Finally, the accuracy and the clinical usefulness of this new, attenuation corrected cardiac SPECT image reconstruction would be quantitatively evaluated. All these procedures apply only to the image data and NOT the patient.

Eligibility Criteria:
Inclusion Criteria:

* subjects scheduled for cardiac SPECT
* subjects 18 years old or older

Exclusion Criteria:

* Females who are pregnant or think that they are pregnant will be excluded in this study.
* Subjects who have a pacemaker, internal defibrillator, prostheses, artificial heart valves, cardiac stents, surgical clips, or TENS (transcutaneous electric nerve stimulator)
* Subjects who are 300 lbs and over
Study Investigating a Standard Regimen in de Novo Kidney Transplant Patients Versus a Calcineurin Inhibitor (CNI)-Free Regimen and a CNI-low Dose Regimen

The purpose of this study is to compare renal function of immunosuppressive regimens with different relevance of the calcineurin inhibitor (CNI) cyclosporine: standard dose CNI, low dose CNI, CNI free in de novo kidney transplant patients after 12 months of therapy.


Eligibility Criteria:
Inclusion criteria

* Males or females, aged 18 - 70 years
* Recipients of de novo cadaveric, living unrelated or living related kidney transplants
* Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at screening, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility.
* Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.

Exclusion criteria

* More than one previous renal transplantation
* Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
* Patients receiving a kidney from a non-heart beating donor
* Donor age: \< 5 years or \> 70 years
* Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
* Other protocol-defined inclusion/exclusion criteria may apply
Internal Carotid Artery Blood Flow in Robot-Assisted Laparoscopic Prostatectomy

The purpose of this study is to evaluate the change of the internal carotid artery blood flow according to the steep trendelenburg position and pneumoperitoneum in patients undergoing robot-assisted laparoscopic prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone robot-assisted laparoscopic prostatectomy with prostate cancer and who are 20 years or older and under 80 years
* Patients who agree to voluntarily participate in this study
* Patients with ASA class 1-2

Exclusion Criteria:

* History of diagnosis of cerebrovascular disease
* Patients who refused to participate in clinical studies
Sufentanil as Adjuvant of Balanced Anesthesia

The aim of the study was to compare the efficacy and safety between sufentanil and remifentanil as an adjuvant of balanced general anesthesia.

The investigators hypothesized that sufentanil would reduce postoperative pain than remifentanil without prolonging recovery times in minor laparoscopic surgery when administered equivalent antinociceptive doses during surgery. Intraoperative opioid administration for equivalent nociception-antinociception balance could be achieved via surgical pleth index (SPI)-guided analgesia. This study was designed to compare the efficacy and safety between sufentanil and remifentanil as an adjuvant of balanced anesthesia in patients undergoing laparoscopic cholecystectomy under SPI-guided opioid administration.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 19 and 65 years
* Patients with American Society of Anesthesiologists physical status I or II
* Patients scheduled for elective laparoscopic cholecystectomy under balanced general anesthesia for benign cholecystic diseases
* Patients obtaining written informed consent

Exclusion Criteria:

* Patients with asthma or hypertension
* Patients with an inability to express their pain accurately
* Patients with an inability to understand the pain scale
* Patients with chronic abdominal pain or chronic pain syndrome
* Patients who required to convert to laparotomy from laparoscopic surgery
* Patients who required to receive incidental lower abdominal procedures owing to adhesion, injury, or other incidental findings at the lower abdominal cavity
* Patients with a history of drug or alcohol abuse
* Pregnant women
Involvement of the Immune System in Intrinsic Radiosensitivity

Radiotherapy is one of the major treatments for cancer. It may be indicated in more than two-thirds of patients, regardless of cancer location or disease stage. The mechanisms of radiotherapy action are numerous: halting tumor proliferation, inducing tumor cell death, triggering anti-tumor immune responses, and ensuring both local and systemic tumor control. As a result, current treatments are highly effective, providing, for instance, a 5-year overall survival rate of about 90%-95% for localized breast and prostate cancers.

In everyday clinical practice, the indications for radiotherapy are based on the benefit-to-risk ratio concerning toxicity. In most cases, radiotherapy causes mild to moderate acute or late side effects, depending on the patient and the volumes irradiated. However, in 1% to 5% of treated patients, these side effects can be severe, unexpected, and often unexplained. The cause of this toxicity remains poorly understood and largely unexplored, especially concerning the intrinsic radiosensitivity of patients.

The PROUST study (French Registry for Review of Morbidity and Mortality; RMM) was initiated in France to prospectively collect clinical, dosimetric, and biological data on individual radiosensitivity in patients who experience severe radiation-induced toxicity. The goal of this study is to better characterize patients with severe radiation-induced toxicities and identify the cellular factors involved in this toxicity.

Although the aim is to identify the cellular and molecular immune factors involved in severe radiation-induced toxicity, we currently cannot determine whether the immune monitoring observed in radiosensitive patients is a consequence of the toxicity itself or of radiotherapy. To answer this question, we have decided to create a control cohort, called TRANSPROUST, which includes patients treated with radiotherapy but who did not experience severe radiation-induced toxicity. After obtaining consent from patients who were treated with radiotherapy but did not develop severe toxicity, we will collect blood samples similar to those taken from the severe toxicity cohort.

These samples will undergo flow cytometry analysis, and the results will be compared with those of patients included in the PROUST cohort.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients who have been treated with radiotherapy
* Absence of toxicity grade 2 or higher
* Patients without psychiatric, sociological, family, or geographical difficulties that could interfere with patient compliance to the protocol or follow-up
* Information and signed informed consent
* Affiliated with social security

Exclusion Criteria:

* Inability to obtain patient consent
* Patient refusing blood sample collection
* Patient deprived of liberty or under legal protection (under guardianship, under curatorship)
* Patients who have experienced radiation-induced toxicity of grade 2 or higher
* Disease progression, relapse
* Patient under State Medical Aid
Thalidomide in the Treatment of Chronic Plaque Psoriasis.

The objective of this study is to obtain information on the effectiveness of thalidomide in psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18 years of age or older.
* Stable or worsening psoriasis that involves 5% or greater of total body surface area (BSA) involvement with a minimum PASI score of 8.
* Moderate to severe plaque-type psoriasis, defined by a minimum score of 1 for each of erythema, scaling, and plaque thickness (using a 0 - 4 scale).
* Patients receiving systemic retinoids, prednisone, methotrexate, or cyclosporine should be on a stable dose at least 28 days prior to the first dose of thalidomide.
* Patients receiving topical treatments should be consistent with such treatments throughout the study.
* The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
* The ability to understand and sign a written informed consent form, which must be obtained prior to treatment.
* The ability to understand, agree to, and comply with the requirements of the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.).\*\*

(\*Because of the known teratogenic effects of thalidomide and in an effort to prevent to the greatest extent possible any chance of fetal exposure to thalidomide, THALOMID(thalidomide) is approved for marketing only under a special restricted distribution program approved by the FDA. Under this program, the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.), only prescribers and pharmacists registered with the program are allowed to prescribe and dispense thalidomide (Zeldis JB et al. 1999). In addition, patients must be advised of, agree to, and comply with the requirements of the S.T.E.P.S. Program. To monitor patient compliance with the S.T.E.P.S. program, all patients must complete the S.T.E.P.S. program informed consent and participate in a mandatory and confidential surveillance registry.)

Exclusion Criteria:

* Unstable psoriasis
* Unable or unwilling to meet all criteria for contraception as required in STEPS.
* Known allergy to thalidomide.
* Known history of neuropathy.
* Abnormal laboratory test results that the investigator feels would compromise patient safety or evaluation of drug safety.
* The introduction of drugs for other medical conditions which are known to affect psoriasis (e.g., lithium, beta-adrenergic blockers, etc.) during the period 4 weeks prior to and during the study period.
* Use of any investigational therapy within the 4 weeks prior to the first dose of thalidomide.
* Expectation of exposure to strong sunlight during the course of the study (e.g. planned holiday in high sunlight area) or intention of sunbathing for prolonged periods of time during the course of the study.
* Current drug or alcohol abuse (drug screening not required).
* Medical conditions that preclude thalidomide therapy. Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
Prospective Cohort Study of Neoadjuvant Therapy With Sintilimab (PD-1 Inhibitor) Combined With Chemotherapy in Resectable ESCC

This study is an open-label, prospective, cohort clinical study to evaluate the safety and efficacy of different cycles of sintilimab in combination with platinum-containing chemotherapy as preoperative neoadjuvant therapy in patients with resectable esophageal cancer. In the study, all subjects who meet the enrollment criteria will be randomized 1:1:1 to receive sintilimab combined with platinum-containing chemotherapy Q3W for 3 cycles (Group A), sintilimab combined with platinum-containing chemotherapy Q3W for 2 cycles + sintilimab for 1 cycle (Group B), sintilimab combined with platinum-containing chemotherapy for 1 cycle + sintilimab Q3W for 2 cycles (Group B) as neoadjuvant therapy, and receive radical surgery within 4-6 weeks after the completion of the last neoadjuvant therapy. Whether the subjects need adjuvant therapy and adjuvant treatment regimen after surgery are determined by the investigator, and all subjects need to complete the follow-up plan formulated by the study after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Preoperative gastroscopy showed that the main body of the tumor was located.
2. Patients with potentially resectable esophageal cancer evaluated by preoperative imaging (chest contrast-enhanced CT, head CT or MRI, abdominal B-ultrasound, PET/CT), and the potentially resectable patients refer to the 2018 edition of the Diagnosis and Treatment Standards for Esophageal Cancer formulated by the National Health and Wellness Commission, defined as patients with esophageal cancer stage T2-3, N0/N+, M0 or T4a, N0-1, M0 (8th edition AJCC stage in 2017).
3. Signed informed consent and met all the inclusion criteria of this study. 4）aged 18\~75 years old 5）ECOG PS score of 0-1;

Exclusion Criteria:

1. prior treatment with immune checkpoint inhibitors, including but not limited to anti-CTLA-4, anti-PD-1 and anti-PD-L1 therapeutic antibodies, and OX-40;
2. .previous systemic therapy;
3. current participation in an interventional clinical trial or receipt of another investigational drug or medical intervention within 4 weeks;
4. presence of active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction (or other factors affecting the absorption of oral medications such as inability to swallow, nausea and vomiting, abnormal physiologic function, malabsorption syndrome, etc.) that require clinical intervention
5. the presence of any signs or history of bleeding constitution; the presence of unhealed wounds, ulcers, or fractures in patients who have experienced any bleeding or hemorrhagic event ≥ CTCAE Grade 3 within 4 weeks prior to enrollment; -
Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer

To see if Disease Free Survival (DFS) is improved when complete surgical resection of liver metastases (R0) is followed by chemotherapy with CPT-11 and 5-FU/FA as FOLFIRI regimen, compared to 5-FU/FA alone.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma of the colon or rectum with complete resection of primary tumour.
* Complete surgical resection (R0) of the liver metastasis(es) within a minimum of 3 weeks, and a maximum of 8 weeks prior to the first study treatment infusion.
* Exclusively hepatic metastasis (es) : absence of bone, lung and brain metastases.

Exclusion Criteria:

* Prior hepatic radiation or resection.
* Prior radiofrequency ablation or cryoablation Incomplete surgical resection of liver metastasis (es).
* Prior chemotherapy for metastatic disease.
PRV-015 in Gluten-free Diet Non-responsive Celiac Disease

This study will evaluate the efficacy and safety of PRV-015 in adult patients with non-responsive celiac disease (NRCD) who are on a gluten-free diet (GFD).

PRV-015-002b is a Phase 2b, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 3 dose regimens of PRV-015 in adult patients with NRCD who are on a GFD.

Eligible subjects include male or female adults, 18 to 70 years of age, with a diagnosis of celiac disease and have followed a GFD for at least 12 consecutive months, yet continue to experience symptoms.

Study drug (1 of the 3 doses of PRV-015 or placebo) will be administered in a double-blind fashion, followed by a safety follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of celiac disease by intestinal biopsy
* Following a GFD for at least 12 consecutive months
* Must have detectable (above the lower limit of detection) serum celiac-related antibodies
* Must have human leukocyte antigen DQ (HLA-DQ) typing consistent with celiac disease (DQ2 and/or DQ8)
* Subjects must have had at least one of the following symptoms at least once per week during the month before screening: diarrhea, loose stools, abdominal pain, abdominal cramping, bloating, or gas.
* Body weight between 35 and 120 kg

Exclusion Criteria:

* Current diagnosis of any severe complication of celiac disease, such as refractory celiac disease type 1 (RCD-I) or RCD-II, enteropathy-associated T-cell lymphoma (EATL), ulcerative jejunitis, or gastrointestinal (GI) perforation
* Diagnosis of any chronic, active GI disease other than celiac disease
* Presence of any active infection
* Selective immunoglobulin A (IgA) deficiency, defined as having undetectable levels of IgA
* Known or suspected exposure to coronavirus disease 2019 (COVID-19) infection in the 4 weeks before screening
* Administration of a live vaccine within 14 days prior to randomization and the first administration of study drug
* History or presence of any clinically significant disease that, in the opinion of the Investigator, may confound the subject's participation and follow-up in the clinical trial or put the subject at unnecessary risk
* Females who are pregnant or planning to become pregnant during the study period, or who are currently breastfeeding
The Genetic and the Functional Study of DNA Repair System and the Susceptibility to Rheumatoid Arthritis

This study is valuable for the understanding the role of DNA repair system plays in the progression of rheumatoid arthritis and for the development of new therapeutic modality in the future.

Rheumatoid arthritis (RA) is a symmetric polyarticular arthritis that primarily affects the small diarthrodial joints of the hands and feet. In addition to inflammation in the synovium, which is the joint lining, the aggressive front of tissue called pannus invades and destroys local articular structures. The synovium is normally a relatively acellular structure with a delicate intimal lining. RA is also a chronic autoimmune disease and can lead to deformities and severe disabilities, due to irreversible damage of tendons, joints, and bones. It is known that RA can be considered as a complex genetic disease and many "disease-risk" genes or "disease-protective" genes can be involved. Numerous studies reported the association of IL-6, IL-8 genes with systemic lupus erythematosus (SLE) and the association of HLA-DR gene polymorphisms with RA. In addition, the chronic inflammatory process of RA is mediated through cytokines network, which leads to induce some destructive enzymes, like matrix metalloprotieases, in the cellular synovial tissue of joints. Although RA is a common arthritis with a prevalence of 1% in Taiwan, the pathogenesis is still incompletely studied, especially in DNA repair relative genes.

In this proposal, we would like to perform the following experiments:

1. Study the associations of the polymorphisms of DNA repair relative genes and the susceptibility to RA;
2. Study the associations of the copy number variation (CNV) of DNA repair relative genes and the susceptibility to RA;
3. Functional assay in DNA repair relative genes and compare it with the copy number variation (CNV), genotype and/or haplotype in RA patients; So far, we have analyzed the association between RA and several SNPs of MUTYH in DNA repair systems. We also analyzed the relationship between the SNPs results and RA using the pathological features. These data are helpful to clarify the susceptibility of RA patients with the genotype and/or haplotype in DNA repair system.

This study is valuable for the understanding the role of DNA repair system plays in the progression of rheumatoid arthritis and for the development of new therapeutic modality in the future.

Eligibility Criteria:
Inclusion Criteria:

* Participant has sang a consent form.

Exclusion Criteria:

* Participant is under 18 years old.