cyrilzakka/clinical-trials huggingface dataset:
Radiotherapy Combined With Endostatin and Capecitabine for NPC

Radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (NPC) resistant to induction chemotherapy.

This study was a single-arm, open-label, phase II study of radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (NPC) resistant to induction chemotherapy. fourty-one patients of locally advanced NPC resistant to induction chemotherapy were enrolled. Patients received radiotherapy combined with recombinant human endostatin and capecitabine. The primary endpoint was Recurrence free survival (RFS). Secondary goals included overall survival (OS), distant metastasis-free survival (DMFS), Local-regional free survival (LRFS); adverse events (AEs) and severe adverse events (SAE); safety and quality of life (QoL).

Eligibility Criteria:
Inclusion Criteria:

Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).

Tumor staged as T3-4N1/N2-3 (according to the 8th American Joint Commission on Cancer edition).

No evidence of distant metastasis (M0). Satisfactory performance status: Karnofsky scale (KPS) \> 70. Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.

Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.

Adequate renal function: creatinine clearance ≥60 ml/min. Patients must be informed of the investigational nature of this study and give written informed consent.

unsatisfactory tumor response (stable or progressive disease) after neoadjuvant chemotherapy (NACT)

Exclusion Criteria:

WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.

Treatment with palliative intent. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.

Pregnancy or lactation. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).

Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.

satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT)
Comparison of the Frequency-altering AKE-1 Capsule and Pillcam SB2

Capsule endoscopy has been shown to be the first-line endoscopic procedure for small bowel disease. This study was aimed to compare the performance between the frequency-altering AKE-1 capsule and the Pillcam SB2 in patients with suspected small bowel disease.


Eligibility Criteria:
Inclusion Criteria:

* obscure gastrointestinal bleeding
* chronic diarrhea
* suspected Crohn's disease
* chronic abdominal pain
* neoplastic lesions of small bowel

Exclusion Criteria:

* patients with any contraindication to capsule endoscopy
Switching From Zidovudine to an NNRTI or Lopinavir/Ritonavir in Patients Treated With Zidovudine/ Lamivudine/Abacavir.

Highly active antiretroviral therapy (HAART) has improved the long time survival of HIV infected individuals. However an increasing number of HIV-patients have developed metabolic and morphological alterations including peripheral lipoatrophy.

The main hypothesis of the study is that switching from thymidine-analogue based HAART will reverse lipoatrophy.

We plan to perform an observational study recruiting up to 100 HIV-infected patients receiving Trizivir (zidovudine/lamivudine/abacavir).

The patients will be offered an NRTI or lopinavir/ritonavir instead of zidovudine or they can choose to continue with Trizivir.

The main endpoint is changes in peripheral fat mass as determined by DEXA-scanning.


Eligibility Criteria:
Inclusion Criteria:

* Currently treated with lamivudine, zidovudine and abacavir
* Viral load \< 200 copies/ml
* Ability to understand and provide written informed consent.

Exclusion Criteria:

* Women being pregnant or breast-feeding.
* Fertile women using no safe contraception.
* Patients with active intravenous drug use.
* Abuse of alcohol, which in the opinion of the treating physician will reduce the patient´s ability to follow a therapeutic regimen and evaluations of the protocol.
* Creatinine \> 200 mmol/l.
* ALT or AST \> 5 times upper normal value (200U/l).
Effect of Combined Use of Naloxone and Tramacet on Postop Analgesia in Elderly Patients Having Joint Replacement Surgery

Patients over 70 years of age, scheduled for joint replacement surgery will be randomized to tramacet/ naloxone plus morphine PCA or to morphine PCA to assess quality of analgesia in the postoperative period.

The primary objective is to determine opioid use during combined use of oral tramacet and naloxone infusion perioperatively in elderly patients (70 yrs and older) having elective knee/ hip arthroplasty under spinal anesthesia.

Secondary objectives are to determine the incidence VAS scores ≥4 and adverse effects such as nausea, vomiting, sedation, respiratory depression, pruritus, confusion, and time of independent mobilization.

Hypothesis: Perioperative naloxone infusion and tramacet provides adequate analgesia in elderly patients undergoing total knee/hip arthroplasty and is associated with 80% reduction in opioid use and reduced opioid-induced side effects.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 70 years and older\*
2. Able to give informed consent
3. Able to communicate in English
4. Having elective hip/knee arthroplasty
5. ASA physical status 1-3.

Exclusion Criteria:

1. Allergies to any of the following: naloxone, tramacet, NSAIDs, or local anesthetic
2. Contraindication to spinal anesthesia
3. Contraindication to use of tramacet or celebrex
4. ASA physical status 4
5. Chronic opioid use
6. Chronic pain syndrome All the above will be included in the letter of information
Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation

The aim of this Phase 3 randomised trial is to compare the efficacy and safety of whole breast radiotherapy to accelerated partial breast irradiation using intensity-modulated radiotherapy technique in selected early breast cancer patients after breast conserving surgery.

The surgeons were requested to place clips at the borders of the surgical bed, using a minimum of four clips. The presence of surgical clips was a selection criterion to avoid geographic misses. Computed tomography (CT) scanning was performed using 0.3-cm thick-slices and a slice spacing of 0.3 cm.

In patients assigned to APBI arm, the clinical target volume (CTV) was drawn with a uniform 1-cm three-dimensional margin around the surgical clips. The CTV was limited to 3 mm from the skin surface and 3 mm from the lung-chest wall interface. A second uniform, three-dimensional 1-cm margin was added to the CTV to obtain the planning target volume (PTV). The PTV was allowed to extend 4 mm inside the ipsilateral lung and was limited to 3 mm from the skin. The ipsilateral and contralateral breast, ipsilateral and contralateral lung, heart, and spinal cord were contoured as organs at risk.

All the regions of interest were contoured according to the International Commission on Radiation Units and Measurements reports 50 and 62 recommendations. No respiratory control was used.

Concerning the experimental Arm (accelerated partial breast irradiation), a dose of 30 Gy in five fractions at 6 Gy/fraction was prescribed.

The following constraints were adopted for plan optimization: PTV coverage: 100% of PTV covered by 95% of the prescribed dose (V28.5 = 100%); maximal dose to PTV \<105% (31.5 Gy); minimal dose to PTV 28 Gy; uninvolved breast (i.e., ipsilateral breast without PTV): not \>50% covered by a dose of \>50% of the prescribed dose (V15 \<50%); ipsilateral lung: not \>20% covered by a dose \>10 Gy (V10\<20%); contralateral lung: not \>10% covered by a dose \>5 Gy (V5\<10%); contralateral breast: maximal dose \<1 Gy; heart: not \>10% covered by a dose \>3 Gy (V3 \<10%).

Eligibility Criteria:
Inclusion Criteria:

* Age at presentation \>40 y
* Tumor size \<25 mm
* Wide excision or quadrantectomy with clear margins (\>5 mm)
* Clips placed in tumor bed
* Full informed consent from patient

Exclusion Criteria:

* Cardiac dysfunction
* Forced expiratory volume in 1 second (FEV1) \<1 L/m
* Extensive intraductal carcinoma
* Multifocal cancer
* Psychiatric problems
* Recurrent breast cancer
Effect of Eye Make up on Ocular Surface

The aim of this study is to compare the degree of tear film instability and severity of meibomian gland loss between subjects who use eyeliner, mascara, a combination of both and those who do not use eyeliner.


Eligibility Criteria:
Inclusion Criteria:

To use eyeliner/mascara or combined for at least 3 days for 6 months for study groups No routine eye make up use for the cıontrol group

-

Exclusion Criteria:

* any systemic or ocular disease taht can affect ocular surface
A Phase I/II Trial of VB-111 and Paclitaxel for Recurrent Platinum-Resistant Müllerian Cancer

This is a prospective, open label, dose escalating, Phase I/II study, measuring mainly the safety and tolerability of the combination of intravenous administration of VB-111 and paclitaxel in patients with platinum resistant ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> 18
* Histologically confirmed epithelial ovarian, peritoneal, or fallopian tube cancer, and uterine papillary serous carcinomas (UPSC), and gynecologic malignant mixed müllerian tumors (MMMTs).
* Must have had prior platinum or platinum based therapy.
* Eastern Cooperative Oncology Group (ECOG) status 0-1.
* Platinum resistant or refractory disease within 6 months of completing or while receiving a platinum and taxane containing regimen
* Measurable disease
* Adequate bone marrow and hematological function.
* Must have recovered from acute toxicity from prior treatment
* Prior treatment with an anti-angiogenic agent is not an exclusion criterion.
* No prior GI perforation, or GI obstruction or involvement of the bowel on imaging
* Known hypersensitivity to Cremophor EL. However, participants are eligible if they have had a prior paclitaxel reaction, but subsequently tolerated the drug at rechallenge.
* No patients receiving other investigational therapy for the past 30 days before dosing.

Exclusion Criteria:

* More than 3 prior lines of chemotherapy for recurrent cancer.
* History of other active malignancy, other than superficial basal cell and superficial squamous cell, or carcinoma in situ of the cervix within last 2 years.
* Life expectancy of less than 3 months
* CTC Grade 1 or greater neuropathy (motor or sensory) from comorbidity other than prior taxane exposure, such as diabetes.
* Inadequately controlled hypertension or prior history of hypertensive crisis or hypertensive encephalopathy.
* New York Heart Association (NYHA) Grade II or greater congestive heart failure.
* History of myocardial infarction or unstable angina within 6 months prior to study Day 1.
* History of stroke or transient ischemic attack within 6 months prior to Day 1.
* Known CNS disease, except for treated brain metastasis
* Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1.
* History of hemoptysis (1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1.
* Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy

The study hypothesis is that new imaging agents \[203Pb\]VMT01 and \[68Ga\]VMT02 can be safely used in humans without independent biological effect and can be used to image melanoma tumors expressing the melanocortin sub-type 1 receptor (MC1R) by SPECT/CT and PET/CT imaging modalities respectively.

This is a first-in-human study evaluating the suitability of \[203Pb\]VMT01 for SPECT/CT imaging and \[68Ga\]VMT02 for PET/CT imaging of MC1R-expressing metastatic melanoma. Study results will provide foundational data to develop imaging and dosing for future therapeutic trials of \[212Pb\]VMT01 for the treatment of metastatic melanoma.

The study will be a cross-over study with the participants serving as their own comparator. Participants with positive FDG-PET scans for stage IV (or inoperable stage III) metastatic melanoma will undergo SPECT/CT scans utilizing \[203Pb\]VMT01 followed a few weeks later by PET/CT scans utilizing \[68Ga\]VMT02, or vice versa. The order of the imaging agents will be randomly assigned.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with Stage IV metastatic melanoma, or inoperable Stage III equivalent
2. Baseline fluorodeoxyglucose (FDG)-PET scan available from within 30 days prior to date of enrollment
3. Blood counts and metabolic results within protocol limits within 14 days prior to enrollment
4. Ability to lie flat and still for a minimum of two hours for imaging
5. Male and female participants with reproductive potential must agree to use highly effective contraception in preparation of the study, during the study, and for 4 weeks following the last dose of an investigative imaging agent
6. Documented life expectancy of at least 3 months

Exclusion Criteria:

1. Active secondary malignancy
2. Prior treatment (for any reason) with radioactive nuclides; imaging tracers are acceptable
3. Pregnancy or breast feeding a child
4. Uncontrolled infection
5. Treatment with another investigational drug within 30 days prior to enrollment date
6. Any treatment with BRAF inhibitors since the baseline FDG-PET scan or plans for such treatment during the study
7. Kidney function not within protocol limits
8. BMI\>40 kg/m2
9. History of a condition resulting in anaphylaxis or angioedema
Body Composition, Dietary Behaviors, Energy Expenditure and Physical Activity Among Moroccan Schoolchildren and Adolescents

Considering the increasing public health concern the obesity in Morocco, the aim of the present study was to use isotope techniques to assess body fat, total energy expenditure and physical activity to inform design and improve interventions for the prevention and control of obesity and related health risks such as diabetes and elevated blood pressure among children and adolescents. Specific objectives of the trial: 1. Determine the extent of obesity and physical activity levels in children and adolescents to design effective interventions in the school setting. 2.Propose alternative field based techniques for assessing body composition and physical activity that could be used in largescale situation assessments and in assessing interventions to address obesity and risk related health care. \* For body composition: BMI z-score, waist circumference, waist measurement at height. \* For physical activity: Questionnaire, Accelerometers 3. To identify factors contributing to the development of obesity and related health risks in schoolchildren and adolescents. 4. Collaborate with stakeholders (government, schools and / or colleges, communities and development partners) in designing interventions to address obesity and health risks. 5. To recommend to stakeholders the most effective interventions in schools to prevent and combat obesity and health risks in children and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy
* Aged between 8 to 14 years old

Exclusion Criteria:

* Hypo or hypervolemic conditions including diet
* Diuretics and oedema
* Private schools
* Rural area
Vascular and Metabolic Effects of Omega-3 Fatty Acids

The investigators hypothesize that omega does-dependently improves vascular and insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* hypertriglyceridemia

Exclusion Criteria:

* overt liver disease, chronic renal failure, hypothyroidism, myopathy, uncontrolled diabetes (HbA1c \> 9%), severe hypertension, stroke, acute coronary events, coronary revascularization within the preceding 3 months, or alcohol abuse
Uterine Microbiome in Women with Repeated Implantation Failure and Normal Fertile Women

Characterization of the uterine microbiome in women with repeated implantation failure as well as in normal fertile women.

In the midluteal phase of the cycle, a vaginal swab and endometrial biopsy will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Women between their 18th and 40th birthdays (max 39 years and 364 days at the day of signing the informed consent)
* Able to understand, read and speak Dutch and hence to provide written and oral informed consent
* Negative serological tests for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), Rapid plasma reagin (RPR) for syphilis

Exclusion Criteria:

* Hormonal contraception in current cycle
* Presence of intra-uterine device
* Antibiotic treatment in the current cycle
Intrabronchial Airway Pressures in Intubated Patients During Bronchoscopy

The purpose of this study is to examine changes in ventilation and airway pressures during conventional bronchoscopy of intubated patients.

Mechanically ventilated patients often need bronchoscopy as a diagnostic procedure or for visually directed elimination of secretions. Partial endotracheal tube occlusion by the bronchoscope increases airflow resistance. Inhibition of inspiratory flow may be compensated for by augmented inspiratory pressure. Reduced expiratory flow however, cannot be compensated for by most ventilators and could lead to higher airway - and intrathoracic pressures that are not detected by pressure transducers in the ventilator tubing. In this study we compare changes in ventilation, airway pressures, ventilator pressures and blood gases during bronchoscopy of intubated patients in both volume controlled and pressure controlled ventilation. Our hypothesis are that 1) increased resistance in the tube during bronchoscopy leads to high intrabronchial airway pressures when the ventilator is in volume controlled mode, and 2) when the ventilator is in pressure controlled mode, increased resistance in the tube during bronchoscopy leads to reduced Tidal Volume and moderately increased paCO2.

Eligibility Criteria:
Inclusion Criteria:

* ARDS/ALI patients on mechanical ventilation
* endotracheal tube size 7-9mm
* age \> 18 years
* therapeutic or diagnostic bronchoscopy requested by staff physician

Exclusion Criteria:

* SpO2 \< 90%
* unstable BP
* pneumothorax
* acute cardiovascular disease
* cerebrovascular or other condition that requires stable BP and saturation
Cervical Manual Therapy and Vagus Nerve Stimulation in Patients With Nonspecific Neck Pain

People with chronic neck pain are becoming more and more common in society every day.

In chronic neck pain investigations, it is generally reported that all people experience neck pain once in my life and more than half of the developed societies experience this problem. It has been stated that 48% of these continue as chronic neck pain, which significantly affects the quality of life due to the postponement of treatment due to its cost.

Eligibility Criteria:
Inclusion criteria for volunteers and/or study participants;

* Presence of neck pain for at least three months
* Non-specific neck pain
* To have signed the voluntary consent form

Exclusion criteria for volunteers and/or participants;

* Having undergone surgery for the cervical region
* Rehabilitation of the neck area at least three months prior to treatment
* Traumatic medulla spinalis injury
* Neurological deficit
* Rheumatological disease
* Structural spinal disorders
Safety Study of Liver Transplantation for Hilar Cholangiocarcinoma

Hilar cholangiocarcinoma is a highly malignant tumor. Surgical resection or simple liver transplantation leads to poor prognosis accompanied by high recurrence rate and low survival rate. The newly proposed neoadjuvant therapy with liver transplantation strategy shows promising clinical application, which once reported 5-year survival rate 82%. However, transplantation centers conducting this kind of research are limited due to its complexity and long-term. The investigators would like to conduct a clinical trial for only unresectable hilar cholangiocarcinoma patients who should take neoadjuvant brachytherapy and chemoradiotherapy followed by orthotopic liver transplantation.

The enrolled patients should be prescribed with several examinations when admitted to hospital consisting of CT, MRI, MRCP, ECT, PET/CT and other laboratory tests. All preoperative examinations must indicate that enrolled individuals should be diagnosed as unresectable hilar cholangiocarcinoma. In addition, repetitive ERCP manipulations are needed in order to obtain positive results by brush cytology. Of course, all enrolled patients should be adherent to the fundamental principles of liver transplantation.

We employed I-125 radioactive plastic stents (patent No: ZL 201610116321.3) to conduct brachytherapy. Each stent composed of a drainage tube with a stab at both ends that had a stabilizing effect. Two opposite channels were made in the wall of stents paralleling the drainage lumen, with irradiation window in the lateral wall of the channel. The diameter of the channel is a bit smaller than that of the radioactive seeds, so as is the length and width of irradiation windows. The stents are so designed to immobilize seeds and radiate properly. The radioactive I-125 seeds were 4.5 mm long and 0.8 mm thick, and their half-life was 60.1 days. The nasobiliary radiography was performed to determine the length of involvement of bile duct.Corresponding radioactive seeds are then put in appropriate location with biliary stents by ERCP procedure.

About a month later, external beam radiotherapy was administrated to a target dose of 30Gy in 30 fractions, 1.5Gy twice per day. Concomitantly, Intravenous capecitabine was given at 1.0g bid for two weeks, which is repeated after 14 days until transplantation.

Immunosuppressive therapy was provided with tacrolimus, mycophenolate and corticosteroids. Corticosteroids were withdrawn a week later. Chemotherapy was continued 1 month after OLT with expected 3 courses.

Eligibility Criteria:
Inclusion Criteria:

unresectable hilar cholangiocarcinoma tumor diameter less than 3 cm adherence to liver transplantation requirements

Exclusion Criteria:

intrahepatic cholangiocarcinoma uncontrolled infection intrahepatic or extrahepatic metastasis distant lymph node metastasis