cyrilzakka/clinical-trials huggingface dataset:
Trofosfamide Versus Adriamycin in Elderly Patients With Soft Tissue Sarcoma (STS)

The goal of this trial is to determine whether oral continuous (metronomic) therapy with trofosfamide results in a similar rate of progression-free time after 6 months as intravenous treatment with adriamycin. In addition, the study is intended to investigate the level of toxicity associated with the two treatment regimens (safety profile).

Group A:Adriamycin (60 mg/m2, d1, qd22) 75 mg/m2 may be applied instead of 60 mg/m2 for patients between 60 and 70 years of age (optional) Group B:Trofosfamide (300 mg absolute p.o. qd over 7 days, then 150 mg p.o. absolute qd continuously) In case of absence of any toxicity during treatment with trofosfamide 150 mg absolute a dose escalation to 200 mg absolute is allowed (optional)

Eligibility Criteria:
Inclusion Criteria:

* Histologically established metastatic (N+ or M1 = stage IV) or non-resectable soft tissue sarcoma·
* Grading II/III (Guillou et al. J Clin Oncol 1997)
* At least 1 measurable tumor parameter according to RECIST criteria
* Evidence of progression or primary manifestation (except osseous metastases and pleural effusion)
* No previous radiation therapy of the only measurable lesion
* No previous chemotherapy for metastatic disease; previous adjuvant chemotherapy is permitted if there was no progression of the disease within a period of 6 months
* Patients aged 60 years and beyond
* Written patient informed consent
* ECOG Status 0-2
* Granulocytes \>= 2 x 10\*\*9/l and thrombocytes \>= 100 x 10\*\*/l
* Serum creatinine, bilirubin \< 1.5 times the upper limit of normal value, albumin \> 25 g/l
* No severe comorbidity including psychosis or any previous history of uncontrolled cardiovascular disease
* Normal left-ventricular function by echocardiography or MUGA scan
* No symptomatic CNS metastases
* Willingness to receive regular follow-up examinations

Exclusion Criteria:

* Histological grading of malignancy: G I
* Histology of gastrointestinal stromal tumor, chondrosarcoma, uterine stromal sarcoma, mesothelioma, neuroblastoma, osteosarcoma, Ewing´s sarcoma/PNET, desmoplastic round cell tumor, embryonal rhabdomyosarcoma, alveolar soft tissue sarcoma
* Less than 5 years free of secondary malignancy except adequately treated carcinoma in situ (CIS) of the cervix, the bladder urothelium, basal cell carcinoma, or adenoma of the colon including pTIS, pTIN
Analysis of Sleep & Recovery Following Rotator Cuff Repair Surgery

Postoperative recovery following a rotator cuff repair surgery can be challenging. In particular, sleeping is difficult given the restrictions of the operative shoulder. This study aims to evaluate a postoperative sleep device that will allow for safe and comfortable positioning of the arm, with the anticipated effect to improve postoperative recovery and sleep.

Postoperative recovery following a rotator cuff repair surgery can be challenging. In particular, sleeping is difficult given the restrictions of the operative shoulder. This study aims to evaluate a postoperative sleep device that will allow for safe and comfortable positioning of the arm, with the anticipated effect to improve postoperative recovery and sleep.

Eligibility Criteria:
Inclusion Criteria:

* Rotator Cuff Tear

Exclusion Criteria:

* Prior ipsilateral shoulder surgery
* Ipsilateral upper extremity neurological deficit
Ultrasound-Guided vs Landmark Technique for Femoral Arterial Cannulation in Pediatric Cardiac Surgery

The use of ultrasound guidance by senior residents learning the technique of femoral artery catheterization is superior to the landmark technique.

The insertion of percutaneous femoral catheter is the method of choice for arterial monitoring in pediatric patients undergoing cardiac surgery at American University of Beirut Medical Center. It is easier to access since it is a bigger vessel and matches better the aortic pressure immediately post initiation of bypass than the radial artery. Utilizing ultrasound in radial artery cannulation has been well described (1). A meta-analysis of 4 trials showed that, ultrasound guidance for radial artery catheterization improved first-pass success rate compared to the palpation method (2). Two of these trials were for pediatric patients where in one study ultrasound-guided radial arterial cannulation in 30 small children improved success rate with fewer attempts required with the ultrasound technique than with the traditional technique (3). However, in another study of 152 children under 12 years of age requiring radial artery cannulation, there were no statistically significant differences between the groups in time to successful cannulation, total number of attempts, number of successful cannulations during the first attempt, or in the number of cannulae used for catheterization (4). No previous study compared the use of ultrasound guidance vs landmark for femoral artery cannulation in the pediatric age group in particular for the teaching of anesthesia residents.

The hypothesis is that the use of ultrasound guidance by senior residents learning the technique of femoral artery catheterization is superior to the landmark technique.

The investigators will design a prospective randomized trial to compare the use of ultrasound guidance versus landmark technique in 110 children undergoing cardiac surgery. The inclusion criteria are ASA III or IV children under 12 years of age. Exclusion criteria are hematoma or infections at the potential site of insertion, need for emergency surgery, and hemodynamic instability.

The risks to subjects include no more than the usual risks of arterial cannulation (infection and hematoma formation). Adverse events will be monitored, reported and treated appropriately.

Privacy and confidentiality will be respected. Data will be kept under lock with the primary investigator.

Eligibility Criteria:
Inclusion Criteria:

1. Infants and children under 12 years of age.
2. American Society of Anesthesiologist Physical Status (ASA) III or IV.
3. Patients with congenital heart disease undergoing cardiac surgery who do not have existing arterial line access.
4. Parents/guardians/patients willing to sign consent.

Exclusion Criteria:

1. Hematoma or infections at the potential site of insertion.
2. Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
3. Need for emergency surgery.
4. Hemodynamic instability
A Phase I Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Leukemia

A chimeric antigen receptor gene-modified T cells (CART: 4SCAR19)by targeted the CD19 (cluster of differentiation antigen 19), treat patients with CD19 positive malignant B cells tumor, assess treatment safety, and observe therapeutic effects. At the same time,the change process of the CART and residual tumor status of the patient are observe dynamically， which summarizes the best therapeutic effect.


Eligibility Criteria:
Inclusion Criteria:

* patients aged more than 6 months.
* the immune phenotype analysis of patients with malignant B cell surface expression CD19 molecules.
* the Karnofsky performance status score over 80 points, is expected to patients survival time is more than 3 months.
* the important viscera function meet: heart ultrasound tip heart ejection fraction 50% or higher, electrocardiogram (ecg) not seen obvious abnormality;The blood oxygen saturation 90% or higher;Creatinine 2.5 times normal range or less; aspartate aminotransferase and aspartate aminotransferase3 times normal range or less, total bilirubin of 2.0 mg/dl or less.
* or greater Hgb 80 g/L.
* no contraindications to solid and cell separation
* the patient and family to have a strong willingness to participate in clinical trials, and are willing to bear all the consequence caused by the test failed, and sign the informed consent.
* the panel discussion, combined with patient general condition, think the benefit is greater than the risks involved in the clinical trials.

Exclusion Criteria:

* accompanied with other active disease, the treatment is difficult to correct.
* bacteria, fungus, or virus infection, unable to control.
* people living with HIV.
* active hepatitis B virus and hepatitis C virus infection.
* of pregnancy and nursing mothers.
* before entering the test of the use of glucocorticoid systemic treatment within a week.
* confirmed before used CAR - but invalid patients treated T cells, after in the physical examination, experts discuss confirmed by a team doesn't fit in the CAR again - T treatment.Before used gene therapy method.
* the researchers believe that might increase risk subjects or interfere with the test results of any situation.
Mediterranean vs. High-Fermented-Food Diet Adherence on Inflammation in Lupus

This is a 4-month randomized controlled trial to evaluate the feasibility of 'good and very good' adherence to the Mediterranean dietary pattern and to a high-fermented-food diet by individuals with Systemic lupus erythematosus (SLE).

Given the demonstrated beneficial effects of the Mediterranean dietary pattern in autoimmune disease and the potential benefit of a high-fermented-food diet on inflammatory profiles, we aim to determine the feasibility and relative benefit of a Mediterranean dietary pattern versus a high-fermented-food diet on inflammatory markers and clinical outcomes in individuals with SLE. The primary aim of the study is to evaluate the feasibility of 'good and very good' adherence to the Mediterranean dietary pattern and to a high-fermented-food diet by individuals with SLE. Secondary aims will determine the effects of the Mediterranean dietary pattern and a high-fermented-food diet on attenuating inflammation and disease activity in individuals with SLE. This is a 4-month randomized controlled trial with a 1-month baseline of usual diet and 3-month intervention. Participants will complete the online DHQ III and diet adherence questionnaires monthly. Blood will be obtained at randomization and at the end of the intervention period for analysis of inflammatory cytokines. Dietary intake during baseline and intervention will be assessed by 5, ASA 24-h dietary recalls.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* Able to provide informed consent and undertake study questionnaire completion in English
* Meets SLE diagnostic criteria and is currently under the care of a rheumatologist, nephrologist, or other physician regarding SLE care
* Be willing and able to comply with all the study-related procedures

Exclusion Criteria:

* Pregnant or planning pregnancy within the duration of the interventional study.
* Currently following a vegetarian/vegan diet.
* Allergy/sensitivity to gluten, soy, or cow's milk.
* Self-disclosure of lactose intolerance
* Inability to comply with the study procedures.
* Baseline dietary fiber intake \> 30 g/day
* MEDAS score at baseline \> 9
* Baseline consumption of \> 2 servings per day of fermented foods
Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer

Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that will be administered every 4 weeks.

Sample size calculation will be done by means of Simon's method in 2 stages for phase II studies and will be based on the principal aim of the study (evaluation of the rate of objective response).

The hypothesis brings over of the efficiency of the treatment it will be accepted if a rate of objective response of at least 55 % is obtained, rejecting the efficiency of the treatment when the rate of response targets be lower than 35 %. In this case, considering an alpha error of 0.05 and 80 % power, 14 patients will be included in the first stage; the study would continue if more than 5 objective responses were found. The total number of patients to including in the study would be 44. The results will be significant if they find at least 20 objective responses.

Assuming a drop-out rate of 10 %, the total number of patients needed is 49 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients must sign an informed consent before of specific procedures of clinical trial.
* Patients with histologically confirmed breast cancer and overexpression of Her2neu.
* Age\> 18 years.
* Eastern Cooperative Oncology Group (ECOG) equal or \< 2.
* Patients have not been treated previously with chemotherapy for metastatic disease.
* Patients must have at least one measurable lesion according to RECIST criteria.
* Patients should have an adequate organ function to tolerate chemotherapy.

Exclusion Criteria:

* Patients with hypersensitivity reactions to any of the medications of the clinical trial.
* Patients who are pregnant or lactating are not eligible.
* Hepatic disease.
* Not controlled active infection
* Symptomatic metastatic brain cancer
* Previous adjuvant treatment with anthracyclines with a total accumulated dose \> 300 mg/m2 (Doxorubicin) or \> 600 mg/m2 (Epirubicin)
Study of the Inappropriate Secretion of FGF23 in Patients Followed in Hospital in a Context of Hypophosphatemia

The discovery of FGF23, the missing link in the long researched and finally found phosphate metabolism, marked a turning point in the understanding and physiopathology of specific hypophosphatemia. By inhibiting the renal reabsorption of phosphate and the production of calcitriol, FGF23 behaves like a hypophosphatemia hormone.

Hypersecretion of FGF23 can occur in the case of genetic abnormalities (X-linked hypophosphatemic vitamin-resistant rickets, recessive or dominant hypophosphatemic rickets, McCune-Albright syndrome ...) or acquired abnormalities (oncogenic osteomalacia). Oncogenic osteomalacia can be induced by hyperproduction of FGF23 by benign tumours of mesenchymal origin. But more recently, several cases of malignant tumours secreting FGF23 have also been described (prostate, colon, breast, ovarian and lung cancers, pulmonary carcinoma, etc.)

To date, even if the incidence of FGF23-secreting tumours seems rare, no precise bibliographical data is available in the scientific literature. Future studies will have to address this issue in order not to underestimate the frequency of this complication.

In this context, investigators would like to study the incidence of inappropriate FGF23 increase from a collection of biological samples carried out on 500 patients treated at the Clermont-Ferrand University Hospital for hypophosphatemia.

Eligibility Criteria:
Inclusion Criteria:

* Major patient, male or female
* Taken care of at the Clermont-Ferrand University Hospital or the Jean Perrin Centre
* In a context of hypophosphatemia (\< 0.80 mmol/L), without immediate anteriority and not occurring during hospitalisation
* In capacity to express informed consent to participate in research
* Affiliated to a social security system

Exclusion Criteria:

* Previously diagnosed hypophosphatemia
* Hypophosphatemia during hospitalisation
* Haemodialysis patient
* Refusal to participate
Comparing the Establishment of Operation Space Between High Position and Low Position in Endoscopic Thyroid Surgery

Patients in our department endoscopic thyroidectomy were randomly divided into high position and low position established operating space group established operating space group. The thyroid size, patient BMI, operation time, and intraoperative blood loss were compared between the two groups.

Patients in our department endoscopic thyroidectomy were randomly divided into high position and low position established operating space group established operating space group.The sternum angle level is used as the dividing line between the two groups。The thyroid size, patient BMI, operation time, and intraoperative blood loss were compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with endoscopic thyroid surgery
* No previous neck surgery

Exclusion Criteria:

* Patients undergoing lateral neck lymph node dissection during the same period
Oligo-metastases NPC Patients Received Radiation for Primary Tumors and Treatments for Metastatic Lesions

Oligo-metastases NPC patients received radiation for primary tumors and treatments for metastatic lesions.

The patients enrolled will received 4-6 cycles chemotherapy at first.Then, radical radiotherapy for nasopharyngeal tumors and local treatments for oligometastatic lesions will assigned to those patients. The efficacy and side-effect will be evaluated and analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically conformed initial non-keratinizing squamous carcinoma in nasopharynx.
2. Clinical stages,T1-4N0-3M1，IVc(AJCC 2010).
3. The metastatic lesions ≤5 and metastatic organs ≤2
4. Karnofsky scores \>70
5. Normal hemodynamic indices before the recruitment (including white blood cell count\>4.0×109/L, neutrophil count\>1.5×109/L, platelet count \>100×109/L, hemoglobin≥90g/l, normal liver/kidney function).
6. Informed consent signed.

Exclusion Criteria:

1. Histologically conformed initial keratinizing carcinoma or others.
2. The metastatic lesions \>5 or metastatic organs \>2.
3. Any severe complications contraindicated chemotherapy or radiotherapy.
4. History of malignant tumors.
5. Pregnant or nursing women.
6. History of radiotherapy or chemotherpy in head and neck regions.
7. Patients refused the informed consent.
Quality of Life and Surgery in Diverticular Disease

Diverticular disease is one of the most common diseases of the gastrointestinal tract in industrial countries. Prevalence and admission rate due to diverticular disease increases.

Symptomatic patients usually present with acute uncomplicated or complicated diverticulitis. Recurrence rates of complicated diverticulitis are estimated to 10-30%. Recurrences, chronic complications or persisting pain, here collectively referred to as chronic diverticular disease, may be treated by elective sigmoidectomy. Currently, there is no specific criteria for elective surgery, but only a recommendation of a tailored approach depending on the patient's symptoms.

It is well established that diverticular disease has a negative impact on quality of life (QoL). Elective laparoscopic sigmoidectomy may increase QoL.

In this prospective study, we will prospectively examine QoL, patient-related outcomes and peri- and postoperative outcome of elective sigmoidectomy for chronic diverticular disease, and compare it to conservatively treated patients.

Design: Prospective, multicentre, observational

Locations: Hospitals in Central and Northern Denmark Region (6 hospitals).

Time: Recruitment starts in April 2022 and is planned to be completed in 2024.

Patients: All patients referred to a surgical clinic due to chronic diverticular disease.

Allocation for surgery or conservative treatment: Patients will be treated according to Danish National Guidelines for treatment of diverticular disease. The study will not influence the treatment of the patient, but only observe and evaluate current daily practice.

Intervention: Patients will be asked to answer questionnaires at inclusion and again after 1 year. Patients treated with sigmoidectomy will also be asked to answers questionnaires 3 weeks and 3 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Referred to surgical clinic due to diverticular disease
* Colonic diverticula verified by CT or endoscopy

Exclusion Criteria:

* Previous colonic resection other than appendectomy
* Previous or current colorectal cancer
* Previous or current disseminated cancer
* Inflammatory bowel disease
* Psychiatric disorder influencing the ability to answer questionnaires
* Inadequate Danish
Frailty in Daily Practice: Screening, Consultation and Education Activities

The present study is designed to to estimate the prevalence of frailty and pre-frailty and their associated factors in community-dwelling populations aged 50 years and above in Hong Kong, and to explore the views of participants taking part in a community health talks or activities on frailty about what the participants felt or had gained from participating, concerns, and suggestions for change or improvement.

A survey of 15000 people aged 50 years or older identified in community facilities will be conducted. The participants will be invited to their affiliated centres for a brief screening using the FRAIL scale and assessment. A series of community health talks or activities on frailty will be offered to the participants based on the frailty status.Questionnaire and screening tools will be administered by trained researchers.

A 30-month community survey will be conducted, and the survey will be divided into three phases, namely study preparation and subject recruitment (6 months), data collection (18 months), and data entry and analysis (6 months).

A survey of 15000 people aged 50 years or older identified in community facilities (e.g., neighbourhood elderly centre, social centre for the elderly) will be conducted. The participants will be invited to their affiliated centres for a brief screening using the FRAIL scale and assessment. A series of community health talks or activities on frailty will be offered to the participants based on the frailty status. Questionnaire and screening tools will be administered by trained researchers.

The primary outcome will be the prevalence of frailty and pre-frailty. Secondary outcomes will cover physical performance measures including hand-grip strength and 5-chair stand test. Anthropometric and demographic data will also be collected using standardized methods and questionnaires respectively.

Views of participants taking part in a community health talks or activities on frailty about what the participants felt or had gained from participating, concerns, and suggestions for change or improvement will be explored by client satisfaction questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* People aged 50 years or older
* Chinese origin
* Normally reside in Hong Kong
* Could speak and understand Chinese
* Willing to follow the study procedures

Exclusion Criteria:

-Live in a residential aged care facility
Rapid Versus Slow Ingestion of Mixed Meal: Influence on Islet and Incretin Hormone Secretion in Healthy Volunteers

To test the influence of rapid versus slow ingestion of a mixed meal on insulin and incretin hormone secretion in healthy volunteers

A mixed meal (524 kcal) is ingested rapidly (within 5 min) or slowly (10-15 min) and changes in insulin, glucagon, GIP and GLP-1 levels are followed for subsequent 300 min

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Diabetes Liver disease Kidney disease Thyroid disease
Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 Diabetes

This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics and pharmacodynamics of single escalating doses of PF-05231023.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between the ages of 30 and 65 years, inclusive, with a historical diagnosis of type 2 diabetes mellitus, diagnosed according to the American Diabetes Association guidelines.
* Body Mass Index (BMI) of 25 to 35.5 kg/m2, and a total body weight \>50 kg (110 lbs).
* HbA1c \>7% and not to exceed 10.5%.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Diagnosis of Type 1 diabetes mellitus
* Evidence of diabetic complications with significant end organ damage.