cyrilzakka/clinical-trials huggingface dataset:
The Culture of Advanced/Recurrent/Metastatic Colorectal Cancer Organoids and Drug Screening

The study aims to establish an organoids platform and apply them to screen drugs for advanced/recurrent/metastatic colorectal cancer patients.

The study was designed as a prospective, observational clinical trial in a single center. We establish organoids derived from patients with advanced/recurrent/metastatic colorectal cancer. Organoids will be validated with a combination of Next Generation Sequencing (NGS) analysis and histopathology. Drug screening assay will be performed on organoids with the chemotherapy and targeted agents, and the sensitivity and speciality will be compared with the clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Patients voluntarily participated in the study and signed informed consent;
2. ECOG score 0\~2;
3. Expected survival over 6 months;
4. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial;
5. CBC: Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L；
6. Serum ALT≤2×UL, AST≤2×ULN; Serum creatinine≤1.5×ULN；
7. Colorectal cancer was unresectable and confirmed as adenocarcinoma by histopathology. Patients have no significant symptoms in the primary lesion (no bleeding, perforation and obstruction in the primary focus). Besides, the carcinoma is potentially resectable but the patient refuses surgery;
8. Patients can comply with the research scheme according to the judgment of the researcher.

Exclusion Criteria:

1. Activity or uncontrol severe infection;
2. Liver cirrhosis, Decompensated liver disease;
3. History of immune deficiency, including HIV positive or suffering from a congenital immunodeficiency disease;
4. Chronic renal insufficiency or renal failure;
5. Other malignancies which diagnosed within 5 years or needed to be treated;
6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
7. Concomitant diseases are treated by drugs that impair liver or kidney function, such as tuberculosis.
Humoral and Cellular Responses to Vaccination Against Coronavirus Disease 2019 (COVID-19) in the Very Elderly Living in Geriatric Institutions

The main objective of this study is to describe the humoral and cellular response to BNT162b2 vaccination in people over age 75 institutionalized in the long-term care units of the Paris Public Hospitals (APHP)

This is an interventional study with minimal risk and constraints, multicenter with biological collection. Two populations are studied: patients and members of care staff.

The following data will be collected:

* For patients and staff: age, gender, existence of Coronavirus Disease 2019 (COVID-19) infection and whether or not it is symptomatic and date of first positive RT-PCR test, medical history
* For patients: nutritional status (loss of appetite, weight loss, body mass index, albuminemia)

Vaccination antibodies are measured using 3 blood sample:

The first carried out before the anti-Coronavirus Disease 2019 (COVID-19) vaccination; the second on D21 (shortly before the vaccination booster injection) and the third on D50-54.

In addition, during the first sample, assays will be carried out informing us of your nutritional and inflammatory status.

Eligibility Criteria:
Inclusion Criteria for patients:

* Person aged 75 and over,
* Hospitalized in a long-term care unit participating in the study,
* Having agreed to be vaccinated with the BNT162b2 vaccine as part of the phase 1 vaccination campaign defined by the health authorities,
* Not having received any other vaccination or corticosteroid treatment during the 3 weeks preceding the start of the study,
* Having given their written consent to participate in the study, or having not expressed their opposition to participating and whose legal guardian has given their consent.

Inclusion Criteria for younger adults (priority care staff):

* Staff who have agreed to be vaccinated with the BNT162b2 vaccine as part of the phase 1 vaccination campaign defined by the health authorities,
* Not having received any other vaccination or corticosteroid treatment during the 3 weeks preceding the start of the study,
* Having given their written consent to participate in the study.
Registry of Hospitalized Patients Treated With Fondaparinux

Registry of Hospitalized patients at Brigham and Women's Hospital treated with Fondaparinux

The use of antithrombotic agents in the hospital is the mainstay of therapy for the treatment or prophylaxis of venous thromboembolism (VTE) and acute coronary syndrome (ACS). Concern with the administration of heparins and risk for adverse sequelae has led to the development of newer, longer-acting agents. Fondaparinux offers once daily administration with only an extremely small risk of developing heparin induced thrombocytopenia.

Recent data have further demonstrated the efficacy and safety of Fondaparinux in VTE and ACS, expanding its use in clinical practice. We aim to: 1) determine how Fondaparinux is being used in a "real life" clinical setting, a tertiary-care academic medical center (BWH), and 2) assess the associated clinical outcomes at 90 days after initiation of Fondaparinux.

Eligibility Criteria:
Inclusion Criteria:

* BWH hospitalized patients receiving Fondaparinux
Isovolumetric and Isocaloric Preloads of Various Types of Milk on Food Intake, Subjective Appetite and Glycemic Response

The purpose of this protocol is to study the effects of fluid milk products on satiety, food intake, and glucose metabolism in healthy young men and women. Experiment 1: The specific objective is to investigate isovolumetric amounts of milk (2% M.F.), chocolate milk (1% M.F.), a soy beverage, cow's milk-based infant formula, and water (control) on satiety and food intake and on blood glucose before and after a meal. A fixed volume approach is based on the commercially available serving size. Experiment 2 will examine equicaloric amounts of milk (2% M.F.), chocolate milk (1% M.F.), a soy beverage, cow's milk-based infant formula, a glucose drink and water (control) the treatments in order to investigate macronutrient composition on satiety and food intake and on blood glucose before and after the meal.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Non-smoking
* Aged 20-30 years
* Body mass index between 20 and 24.9 kg/m2

Exclusion Criteria:

* Diabetes
* Medication
* Lactose-intolerance or allergies to milk
* Breakfast skippers and those on an energy restricted diet
A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

Patients in community-based practices correspond to the 25% of patients who need a first add-on drug when not controlled by their standard monotherapy drug. This was a therapeutic use trial in which the population corresponds more closely to that seen in daily clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* partial onset seizures with or without secondary generalisation with epilepsy.

Exclusion Criteria:

* hypersensitivity to levetiracetam or other pyrrolidone derivatives or to any of the excipients.
Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea

The National Health Plan 2001-2010 calls for investigation of the feasibility of pneumococcal vaccines for Papau New Guinea. The Papua New Guinea (PNG) Institute of Medical Research, the Telethon Institute for Child Health Research and the Department of Paediatrics, University of Western Australia will collaborate to examine very closely the safety of neonatal vaccination, particularly with regard to impact on the development of immunity and response to other vaccines given to infants. This study will also provide a unique opportunity for training of PNG and Australian scientists in both countries.

In order to obtain the earliest possible protection against invasive pneumococcal disease, achieve optimal coverage and reduce burden of early carriage, neonatal pneumococcal conjugate vaccine (PCV) immunization needs to be considered. This study in the PNG highlands will enrol 312 infants at birth, who will be randomised to receive PCV either at 1-2-3 months (infant schedule according to PNG national EPI schedule) or 0-1-2 months of age (neonatal schedule) or receive only routine immunizations (controls). Blood samples will be taken at birth-2-3-4 months of age, pre- and post-pneumococcal polysaccharide booster (23vPPV) at 9-10 months of age (to assess immune memory) and at 18 months at study completion. Carriage will be assessed weekly for the first month of life and at regular intervals thereafter. There will be ongoing surveillance for respiratory and other diseases throughout the study. In addition to serotype-specific IgG, we will examine IgG avidity, IgG subclasses, mucosal IgA and T-cell cytokine responses to PCV and pneumococcal protein antigens. To ensure immunological safety, particularly for neonatal PCV, immune responses to concomitant vaccines and viral and environmental antigens will also be examined as well as overall T-cell maturation.

Eligibility Criteria:
Inclusion Criteria:

New born babies with birth weight \>2000 g (2 kgs) and parents giving consent

Exclusion Criteria:

1. Acute neonatal infection;
2. Severe congenital abnormality;
3. Children of mothers known to be HIV positive will be excluded;
4. Serious asphyxia at birth;
5. Intended migration in the next 2 years;
6. Parents withdraw consent;
Efficacy and Safety of Xience in Coronary arEry Disease aLL-comers After stENTing Using the PRIME Platform (EXCELLENT-PRIME Registry)

Objectives:

1. To evaluate the safety and long-term effectiveness of coronary stenting with the XIENCE PRIMETM in a cohort of "real world" patients and lesion subsets.
2. To determine clinical device and procedural success during commercial use of XIENCE PRIMETM coronary stent

Study population : Approximately consecutive 2000 patients treated with XIENCE PRIMETM

Study period

* Patient enrollment: 2011.05 \~ 2012.04
* End of follow-up period: 2015. 02 (3 years of follow-up)

Primary endpoint

: Target Lesion Failure (TLF) rate at 12 months

Secondary endpoint:

* In-stent \& In-segment Late Loss at 9 months
* Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3 years (very late)
* Target Vessel Failure at 12 months (composite of cardiac death, MI, and TVR)
* Any death, cardiac death, MI, TLR, TVR at 30 days, 9months, 1 year, 3 years
* Composite rate of cardiac death and any MI up to 3 years
* Composite rate of all death and any MI up to 3 years
* Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization up to 3 years
* Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years
* Procedural success up to 1 day
* Angiographic success up to 1 day


Eligibility Criteria:
Inclusion Criteria

* The patient agrees to participate in this study by signing the informed consent form. Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.

Angiographic Inclusion Criteria

* There are no angiographic inclusion criteria for this study.

Exclusion criteria

* There are no exclusion criteria for this study.
Management of Major Trauma Patients at Aarau Trauma Center - Evaluation of Processes and Patient Outcome

Quality control and improvement project: Assessment and analysis of processes and outcome in trauma emergency room and major trauma patients at the Aarau trauma center (cantonal hospital) with regard to initial emergency management, hospital processes and short- and long-term (1-and 2-year) outcome of patients (subjective and objective). Comparison of processes and outcome pre- and post- project initiative. Benchmarking with the literature and by participation in the German and Swiss Trauma registry each.

Registry of all emergency patients arriving at Aarau trauma center following trauma with regard to possibly injury related pre- and inhospital demographic factors, process variables and outcome Parameters.

Eligibility Criteria:
Inclusion Criteria:

* major trauma: New Injury Severity Score (NISS) \>=8
* for longer-term outcome: only patients firm in German language and able to respond to the postal questionnaire by themselves

Exclusion Criteria:

* no Trauma
* injury \>24h before arrival at Aarau Cantonal Hospital
* NISS\<8
* for longer-term outcome: patients not firm in German language and not able to respond to the postal questionnaire by themselves (dead, unavailable, refusal to participate, dementia, age\<16 years ecc.); a categorising compilation of cases is supposed to exclude any possible study bias
Initial Dosing of Paricalcitol in Secondary Hyperparathyroidism

The purpose of this study was to compare two different initial dosing schemes for the administration of paricalcitol in hemodialysis patients with secondary hyperparathyroidism: the already in use iPTH/80 scheme, and an iPTH/120 scheme, which corresponds to the immediately lower dose, based on current instructions on paricalcitol dose adjustment. We studied the effectiveness of the two dosing schemes in achieving a target iPTH level (150 - 300 pg/mL)

Adjustment of the initial dose of paricalcitol, in hemodialysis patients with secondary hyperparathyroidism (sHPT), on the basis of severity of sHPT is generally preferred in current practice. Whether the proposed dose, based on the formula baseline intact parathyroid hormone (iPTH \[pg/mL\]) divided by 80, is the most appropriate has not been adequately assessed. A trial comparing the iPTH/80 dose to the immediately lower iPTH/120 dose was undertaken. We studied the ability of the two different dosing schemes to control iPTH levels within a desired range between 150 and 300 pg/mL, as well as the frequency of iPTH over-suppression (\< 150 pg/mL) in the two groups (iPTH/80 and iPTH/120).

Eligibility Criteria:
Inclusion Criteria:-maintenance hemodialysis therapy (3 sessions per week) for at least 3 months; iPTH between 300 and 900 pg/mL; age \> 18 years; normal serum calcium concentration (8.1 - 10.4 mg/dL); Ca x P product less than 70; no vitamin D metabolite replacement therapy for at least one month prior to the enrollment; aluminum levels lower than 60 μg/L.

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Exclusion Criteria:administration of calcitonin, disphosphonates or corticosteroids; presence of a clinically serious medical condition; previous parathyroidectomy; active malignancy.

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Study of Safety, Tolerability, and Pharmacokinetics of Topical Selinexor (KPT-330) Diabetic Foot Ulcer (DFU) Patients

Patients with eligible diabetic foot ulcers will be screened, treated, and followed for complete ulcer closure. This is a randomized trial. All patients will receive standard-of-care treatment. Additionally, some patients will receive treatment with topical Selinexor gel and some will receive topical placebo gel.

Approximately 30 patients who meet the eligibility criteria will be enrolled. Eligible patients with diabetic foot ulcers will be screened, randomized, treated, and followed for complete ulcer closure.

After screening, qualified patients will be treated for up to 12 weeks. Patients who achieve complete ulcer closure will be followed for an additional 12 weeks.

All patients will receive standard-of-care treatment. After randomization some patients will be treated with topical Selinexor gel twice weekly and some patients will be treated with a topical placebo gel twice weekly. Patients receiving Selinexor will be assigned to a sequential treatment cohort, either a 10 μM (μmol/L), 30 μM, or 70 μM dose.

Eligibility Criteria:
Inclusion Criteria:

* Patient has a clinical diagnosis of Type I or Type II diabetes mellitus with an HbA1c ≤ 10.0 and has a BMI ≤40.
* The DFU(s) to be treated must be:

  * Anatomically discrete,
  * Non-healing, but has persisted for ≤12 months
  * Measures 1 cm2 ≤ area ≤ 5 cm2 following debridement,
  * Has a Wagner Grade 1 (i.e., not involving bone, muscle, tendons, or ligaments),
  * The Target DFU is located distal to the ankle (i.e., below the malleolus), and
  * Is able to be adequately off-loaded.
* The patient has adequate arterial blood supply in the affected limb at screening.
* Patient has the inability to perceive 10 grams pressure in the peri-ulcer area and other regions of the affected foot and toes using Semmes-Weinstein 5.07 monofilament at screening.

Exclusion Criteria:

* Patient has a foot ulcer that is clearly of non-diabetic pathophysiology.
* Patient has more than two (2) DFUs on the target lower extremity.
* DFU is clinically infected.
* Patient has active osteomyelitis of the foot or active, uncontrolled, connective tissue disease
Efficacy of Nasal Spray Calcitonin on Recurrence of Aggressive Central Giant Cell Granuloma

The main objective of this randomised clinical trial is to is to compare the frequency of recurrence between patients who received nasal spray calcitonin after curettage of Central Giant Cell Granuloma and without it.

A total of 24 patients with aggressive Central Giant Cell Granuloma (CGCG )will be selected . All examinations were performed by calibrated clinicians and gender, age, medical history, symptoms, lesion size and site, disease duration and form of treatment were recorded for all participant. Radiographic examination with cone beam computed tomography (CBCT) and panoramic radiograph was done for all patients. All patients were randomly assigned to one of two treatment groups; 2 weeks after the biopsies were taken.

The case group (n =12 with) underwent 200 IU/day ones a day for 3 months after the surgeries. conservative curettage surgical procedure was done for them. while placebo was treated by curettage of CGCGs and received a placebo ones a day for 3 months after surgeries.. Patients were followed up by a maxillofacial surgeon who did not participated in surgeries.None of surgeons did not aware about the research before and during the operations.Patients were blinded from the drugs which they received after surgeries.

All patients were follow up for 5 years after operations. Recurrence lesions were documented by clinical and radiographical examinations and proved by histopathological evaluation.

Eligibility Criteria:
Inclusion Criteria:

* clinical and histopathological diagnosis of aggressive CGCG based on accepted criteria established by chuong etal normal level of calcitonin and serum Parathyroid hormone(PTH) Patients of both sexes between 13 to 30 year's old Patients who gave written informed consent Patients who were willing for evaluation in the fallow up session Primary size of the lesion should be more than 5 cm in CBCT

Exclusion Criteria:

* Participants demonstrating a systemic disease which affects bone healing,brown tumor ,pregnancy , recently corticosteroid therapy , previous surgical intervention for CGCG or refused study enrollment and whom they could not continue the study for private or social reasons were excluded from the study sample.
Effect of Preoperative High-dose Cholecalciferol in Prevention of Post-thyroidectomy Hypocalcaemia

Hypocalcaemia after thyroidectomy is observed with increasing frequency, often resulting in prolonged hospital stay with increased use of resources, delayed return to work and reduced quality of life. The administration of vitamin D is essential in the therapy of postoperative hypocalcaemia. What has not been examined so far is whether and how routine preoperative cholecalciferol prophylaxis can help to prevent postoperative hypocalcaemia

Hypocalcemia following thyroid surgery is caused either due to parathyroid devascularization, stunning, or accidental removal of the parathyroid glandsMultiple risk factors have been identified which predispose patients to develop post-operative hypocalcemia. In light of the available evidence of prevalent vitamin D deficiency in the general population, and the observation of appearance of postthyroidectomy hypocalcemic symptoms at a much earlier stage than documented in previous literature, we postulate that a prophylactic vitamin D supplementation dose given in immediate preoperative period can significantly reduce acute symptomatic postoperative hypocalcemia in patients undergoing thyroid surgery

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 18 years)
* Scheduled for TT
* Thyroid cancer treated with total thyroidectomy without lymph node dissection

Exclusion Criteria:

* Lack of written consent
* Thyroid cancer treated with TT and lymph node dissection
* Mediastinal goiter with need for sternotomy
* Medication with thiazide diuretics, digitalis or lithium therapy
* Previous neck operations or radiation
* Preexisting hyperparathyroidism
* Chronic kidney failure.
A Novel Suturing Technique of Cystocele Treatment

The rug weaving-like plication technique may offer a viable alternative for cystocele repair without mesh, utilizing natural tissue.

The aim of this study is to compare patients who underwent cystocele repair using the rug weaving plication technique, a natural tissue repair method implemented since 2022 for anterior prolapse, with those treated using conventional techniques.

The investigators retrospectively reviewed 33 patients who underwent anterior vaginal wall repair with the rug weaving-like plication technique and 32 patients who underwent surgery using conventional colporrhaphy. The investigators recorded demographic data and operative details of the patients. At the 6-month postoperative follow-up,the investigators assessed patients' complaints, Pelvic Organ Prolapse Quantification (POP-Q), Modified Oxford Scoring (MOS), and pelvic floor muscle strength. The investigators measured bladder wall thickness between the bladder and anterior vaginal wall using Transvaginal Ultrasonography (USG) and compared demographic data, operative details, and postoperative outcomes between the two groups.

Eligibility Criteria:
Inclusion Criteria: Patients operated on using the rug weaving plication technique

Exclusion Criteria:Patients operated on using the conventional anterior colporrhaphy