cyrilzakka/clinical-trials huggingface dataset:
Effect of All-trans Retinoic Acid With Chemotherapy Based in Paclitaxel and Cisplatin as First Line Treatment of Patients With Advanced Non-small Cell Lung Cancer

Purpose:

This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel plus All-trans retinoic acid (ATRA) increases Response rate (RR) and Progression-free survival (PFS) in patients with advanced Non-small cell lung cancer (NSCLC) with an acceptable toxicity profile and its association with the expression of Retinoic acid receptor beta 2 (RAR-beta2) as a response biomarker.

Patients and Methods:

Patients with stage IIIB and IV NSCLC were included to receive Paclitaxel and Cisplatin (PC). Patients were randomized to receive ATRA 20 mg/m2/day (RA/PC) or placebo (P/PC) 1 week prior to treatment until completing two cycles. RAR-beta2 expression was analyzed by Immunohistochemistry (IHC) and RT-PCR in tumor and adjacent lung tissue.

Purpose:

This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel plus All-trans retinoic acid (ATRA) increases Response rate (RR) and Progression-free survival (PFS) in patients with advanced Non-small cell lung cancer (NSCLC) with an acceptable toxicity profile and its association with the expression of Retinoic acid receptor beta 2 (RAR-beta2 ) as a response biomarker.

Patients and Methods:

Patients with stage IIIB and IV NSCLC were included to receive Paclitaxel and Cisplatin (PC). Patients were randomized to receive ATRA 20 mg/m2/day (RA/PC) or placebo (P/PC) 1 week prior to treatment until completing two cycles. RAR-beta2 expression was analyzed by Immunohistochemistry (IHC) and RT-PCR in tumor and adjacent lung tissue.

Eligibility Criteria:
Inclusion Criteria:

* Stage III B and IV NSCLC
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* No prior cytotoxic chemotherapy for NSCLC
* Age ≥18 years, adequate laboratory measurements
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
* Life expectancy of \>12 weeks.

Exclusion Criteria:

* Patients who had received prior chemotherapy
* Patients with other comorbid conditions
Nutrition Practice in Critically Ill Adults

To determine the role of nutrition in recovery from critical illness, current practice must first be understood. However, no benchmarking process currently exists for nutrition practice during critical illness, from ICU admission to hospital discharge. This vital gap requires addressing.

The aim of this study is to inform and re-design models of nutrition care and generate research priorities for the future by obtaining data on nutrition provision and practice and that of consumer preference for nutrition care.

This study is a multi-centre observational study of nutrition practices in critically ill adults across ANZ. Two study periods are proposed, the first confirmed period in Q3-2024 and the second in 2026.

This study is part of a larger study which consists of three interconnected streams. This study forms part of Stream 2 which is about understanding nutrition practice and provision in adults with critical illness. The findings from this study will be used to inform the development and implementation of new models of nutrition care for adults with critical illness.

On the day of study commencement (day 1), all patients treated in the ICU and admitted to the ICU after 00:00 will be screened for eligibility. Observational data will be collected days 1 and 3 of their ICU stay (whilst present in ICU) and then days 7, 14, 21 and 28 (whether they are in ICU or the ward) as well as the first full day on the ward (day after ICU discharge).

At the completion of the project, the investigators will hold the largest sample of nutrition care in critical illness in Australia (approximately 1200 Adult patients including the pilot data period) and the only international database to include the period after ICU discharge. This proposal directly links with the National Safety and Quality Health Service (NSQHS) Standard 5 (Comprehensive Care) and Standard 2 (Partnering with Consumers) and will rapidly provide data about nutrition care and hospital acquired malnutrition (a serious reportable consequence under Standard 5) to inform the accreditation process and provide a risk mitigation strategy to prevent malnutrition before it occurs. This data will be used to improve and re-design nutrition care, as well as generate new research priorities that are highly relevant to issues within clinical care, with the potential to save millions of dollars in healthcare expenditure nationally.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Admitted to ICU after 00:00 on the date of study commencement
3. Remain in ICU for ≥ 48 hours

Exclusion Criteria:

1. Patients who have been deemed ready to be discharged by the treating team within 48 hours of ICU admission but have not been able to be discharged within 48 hours of ICU admission for logistical reasons (e.g., due to bed unavailability, inability to return home)
2. Patients who have been admitted for palliative care or organ donation or made palliative within 48 hours of ICU admission
Oral Glutathione Supplementation on the Levels of Blood Glutathione

This trial is designed to provide evidence of the efficacy of glutathione supplementation and health(GSH) and includes the assessment of both short term and long term effects. Based on previous laboratory animal studies and clinical data, the investigators anticipate that the effects of oral GSH supplementation will be progressive and cumulative. The study will also allow for the evaluation of effects of withdrawal of the supplement on the outcome variables.

This is a randomized double-blind, placebo-controlled study in which the treatment allocations will be kept sealed until the final statistical evaluation. The design will include the recruitment of 60 healthy subjects (30-79 yr of age) randomized into 3 groups. A total of 48 subjects, 16 per group will be required based upon power calculations and results from a previous clinical trial with selenium. An additional 4 subjects per group will be placed on trial to account for possible attrition or non-compliance. Blood, urine and exfoliated buccal mucosal samples will be obtained from all subjects at baseline. Questionnaire data on usual dietary intake will also be obtained at baseline. Eligible subjects will be required to have not have taken any high dose antioxidant supplements for at least 1 month prior to the study. Subjects will then begin supplementation according to the following schedule:

Group A, GSH (500 mg, 2 times daily); Group B, GSH (125 mg, 2 times daily); Group C, placebo (2 times daily). Eligible participants who sign the informed consent will be randomly assigned to either placebo or high or low dose Glutathione groups. Participants will be asked not to consume any other high-dose vitamin, multi-vitamin, or mineral supplements containing glutathione throughout the study in order to prevent variation in dose of supplemental GSH between subjects. Supplementation will continue for 6 months with biological samples collected at 1, 3 and 6 months after baseline. At 6 months, supplementation will be discontinued. A final collection of biological samples will occur 1 month afterwards. Compliance will be monitored by pill count.

Levels of glutathione will be measured in plasma, lymphocytes, and red blood cells as well as in exfoliated buccal mucosal cells. Biomarkers of oxidative stress will include blood levels of glutathionylated proteins and 8-isoprostanes and urine levels of 8-hydroxydeoxyguanosine. Glutamylcystine ligase and GST activities, and C-reactive protein will be determined in blood. Immune function biomarkers will be analyzed including t-natural killer cell cytotoxicity, lymphoproliferation, neutrophils phagocytosis, neutrophil respiratory burst assays.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and females between the ages of 30 and 79 years of age
* Not taking glutathione as a dietary supplement
* Not taking high dose antioxidant supplement prior to 1 month
* Baseline blood glutathione level of \< 1 mmol/L

Exclusion Criteria:

* History or evidence of disease including cancer, diabetes, heart disease
* Subjects who smoke
Spray Diathermy Versus Harmonic Scalpel Technique for Hepatic Parenchymal Transection

Consecutive patients, who were treated for end stage liver cirrhosis by LDLT were included in this a prospective study.Patients enrolled in the study divided into two groups according to the day of surgery. The study population was divided into two groups; group (A) Parenchymal liver transection was performed by harmonic scalpel (HS) and group (B) Parenchymal liver transection was performed by spray diathermy (SD).

Consecutive patients, who were treated for end stage liver cirrhosis by LDLT were included in this a prospective study.Patients enrolled in the study divided into two groups according to the day of surgery. The study population was divided into two groups; group (A) Parenchymal liver transection was performed by harmonic scalpel (HS) and group (B) Parenchymal liver transection was performed by spray diathermy (SD).

Donors and recipient were followed up after hospital discharge with laboratory investigation, abdominal ultrasound, MRCP in selected cases every month for the first month, then every 6 months and then every year postoperatively. Follow up visits included clinical examination, laboratory investigation, doses of immunosuppressive, radiological examination, and doppler US.

The primary outcome was the amount of blood loss during transection. Secondary outcomes were operative time, time of transection, speed of transection/minutes , number of ligation used, degree of postoperative injury which assessed by daily liver function, WBC, C reactive protein, pathological changes at the cut surface, postoperative morbidity (including biliary leakage, collection), cost and hospital stay.

Eligibility Criteria:
Inclusion Criteria:

Consecutive patients, who were treated for end stage liver cirrhosis by LDLT

Exclusion Criteria:

-
Effectiveness of an Online Intervention Using a Feminist Approach on Gender Equality Promotion and Sexual Violence Prevention in China

This paper presents the findings of a clustered randomized controlled trial (cRCT) that evaluated the effectiveness of an online feminist sexual health intervention among Chinese young adults, providing insights into the impacts of this innovative approach and contribute to the growing body of literature on feminist interventions for sexual health and equality promotion.


Eligibility Criteria:
Inclusion Criteria:

1. Young adults aged between 18-29 years old who possessed a mobile phone
2. Had prior experience in using social media
3. Were able to read and understand Chinese

Exclusion Criteria:

1. Those with a physical impediment (e.g., blindness) preventing them from accessing the mobile content
Impact of Pilates and Myofascial Release on Women's Chronic Low Back Pain

The aim of this study is to find out if Reformer Pilates and self-myofascial release are effective for pain and muscle function in women with chronic low back pain. Investigators will also look at changes in quality of life. The main questions for the study are

Can Reformer Pilates and self-myofascial release reduce pain in participants? Can Reformer Pilates and self-myofascial release change muscle function in participants? The researchers want to compare the effects of Reformer Pilates and self-myofascial release in women with chronic low back pain.

Participants will be

Group 1 Perform Reformer Pilates and self-myofascial release exercises twice a week for 6 weeks, for a total of 12 sessions.

Group 2 Perform Reformer Pilates exercises twice a week for 6 weeks, for a total of 12 sessions.

Participants will visit the Pilates Centre for an examination before and once after starting the programme.

All groups perform a home exercise training programme for 15 minutes three times a week.


Eligibility Criteria:
Inclusion Criteria:

* People who have had chronic low back pain for 12 weeks or more
* Have a Korean Oswestry Disability Index (KODI) score of 17% or higher

Exclusion Criteria:

* Patients with low back pain due to trauma, neurological lesions of the lower extremities, herniated disc lesions, hip, pelvic or abdominal surgery
* Patients who have received radiation or injections within the last 3 months,
* Pregnant women or patients who have given birth within the last year
Movement System Impairment Based Classification Versus General Exercise for Chronic Non-specific Low Back Pain: a Randomised Controlled Trial

The objective of this study is to investigate the efficacy of a treatment based on Movement System Impairment based classification (MSI) model in patients with chronic non-specific low back pain.

The subjects will be recruited from orthopedic outpatient clinics as well from the community. The examiner will screen the eligibility of each subject based on the eligibility criteria. All eligible subjects will receive information about the study and will sign an informed consent form before participating in the study.

The examiner will collect the baseline data prior to randomisation. This examiner will be blinded to patients' allocation to treatment groups. The subjects will be randomly allocated to one of two groups (treatment based on MSI model or general exercise) using a computer-generated randomisation schedule conducted by a study researcher who will not be involved with the patients and assessment of outcomes. Participant allocation will be kept in a sealed opaque envelopes using a random numerical sequence. The examiner, responsible for the treatment will open the envelope in front of the patient and will communicate him about which treatment group he will be part of. The clinical outcomes of this study will be assessed before, after the treatment (2 months) and at 4 and 6 months after randomisation.

Descriptive analyses will be done to check for data normality. The between-group comparisons to obtain the mean effects of the treatments will be conducted by means of interaction terms (group versus time interactions) using Linear Mixed Models. All data will be given to a statistician who will perform the statistical analysis in coded form. The statistical analysis will be done according to the principles of intention to treat. The SPSS 19 and SigmaPlot 10 will be used for these analyses.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of both genders between 18 and 65 years of age with chronic non-specific LBP (pain for more than 3 months) with a pain intensity of at least 3 points measured by a 0-10 points pain numerical rating scale
* Subjects must be able to stand and walk independently
* Subjects must be able to read in Portuguese

Exclusion Criteria:

* Subjects with any contraindication to physical exercise according to the guidelines of the American College of Sports Medicine
* Subjects with severe depression (measured by depression, anxiety and stress scale - DASS)
* Subjects with serious spinal pathologies (fractures, tumors, and inflammatory pathologies such as ankylosing spondylitis), nerve root compromise (disc herniation and spondylolisthesis with neurological compromise, spinal stenosis, and others), serious cardiorespiratory diseases, previous back surgery or pregnancy.
* Subjects that cannot be classified into any of the five categories of the Movement System Impairment model upon initial assessment
Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease

This Phase 1 study will determine the safety, tolerability, and pharmacokinetics of vinorelbine liposomes injection (VLI) in patients with advanced solid tumors, non-Hodgkin's lymphoma, or Hodgkin's disease.

The objectives of this study are:

* To assess the safety and tolerability of treatment with VLI.
* To determine the maximum tolerated dose (MTD) of VLI.
* To characterize the pharmacokinetic (PK) profile of VLI.
* To explore preliminary tumor response of VLI.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed solid tumor refractory to standard therapy or for which no standard therapy is known to exist, or relapsed and/or refractory non-Hodgkin's lymphoma or Hodgkin's disease
2. Adequate hematologic, hepatic and renal functions as defined by laboratory tests.
3. At least 18 years of age.
4. Have a life expectancy of at least 12 weeks.
5. Patients must give written informed consent.
6. ECOG or Zubrod performance status of 0, 1, or 2.

Exclusion Criteria:

1. Primary tumors of central nervous system (CNS). Symptomatic brain metastases (unless patient is stable without requirement of steroids and/or antiseizure medications for at least 3 months) or leptomeningeal tumor involvement.
2. Prior chemotherapy or radiotherapy within 4 weeks prior to study entry (6 weeks for nitrosoureas and mitomycin C).
3. Planned concurrent systemic therapy and/or radiotherapy drug study treatment.
4. Use of investigational drugs, biologics or devices within 28 days prior to study treatment or planned use during the course of the study.
5. Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment.
6. Prophylactic hematologic growth factors administered less than or equal to 2 weeks prior to start of therapy with VLI (excluding darbepoetin alfa, epoetin alfa).
7. Female patients who are pregnant or lactating.
8. Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent.
Whole Body Dynamic 68Ga-DOTATOC PET/CT in Neuroendocrine Tumors

Neuroendocrine tumors (NET) are a network of rare tumors with common embryological origin. Functional imaging plays a major role in the extension assessment and tumor characterization of NETs. SPECT/CT with 111In-pentetreotide is the recommended test when tumors are well differentiated (grade G1 or G2). It has a real interest in diagnosis, in therapeutic decision-making (in particular by cold somatostatin analogues or in PRRT) and in the systematic follow-up of patients. Nevertheless, SPECT/CT procedure makes for a relatively long review. In addition, scintigraphy has a lower spatial resolution than PET technology and remains of limited interest for signal quantification.

However, the ability to locate and quantitatively measure the absorption of radiopharmaceuticals in the target tissues is a major challenge in oncology for the characterization of the disease.

Recent developments in radiopharmacy have made it possible to target NETs in PET imaging through the use of somatostatin analogues coupled with positron emitters, called 68Ga-DOTA peptides. The diagnostic performance of 68Ga-DOTApeptide PET/CT appears to be superior to SPECT/CT with 111In-pentetreotide. A marketing authorization has thus recently been issued in France for the use of 68Ga-DOTATOC.

Historically, the recommended quantification method in PET was based on the instantaneous measurement in static acquisition (3D) of the maximum of the standardized uptake value (SUVmax). This approach has the disadvantage to measure the signal at a time "t" for a single voxel of the image. Dynamic acquisition methods (4D) have been proposed to extract a radiotracer absorption coefficient (Ki) for a lesion. Several studies have demonstrated the superiority of Ki versus SUVmax in 18FDG PET/CT for the diagnostic management, therapeutic evaluation and prognosis of various solid cancers.

However, no work has validated this approach in PET / CT at 68Ga-DOTATOC as part of the prognostic evaluation of NETs.

The objective of the study is to evaluate the prognostic value of the tumor absorption coefficient Ki resulting from a 4D whole-body dynamic acquisition in PET / CT at 68Ga-DOTATOC in patients with well-differentiated NETs grade I or II according to the WHO classification


Eligibility Criteria:
Inclusion Criteria:

* Patient majeur ≥ 18 year old
* Présenting a well differentiated neuroendocrine tumor (G1 ou G2)
* Indication performing a68Ga-DOTATOC PET/CT
* non-opposition

Exclusion Criteria:

* Patient \<18 years old
* Breastfeeding/ pregnancy
* Other type of tumor
* Refusal of participation
Evaluating Safety and Efficacy of Mesenchymal Stem Cells From Umbilical Cord

This study was to evaluate the safety and efficacy of Mesenchymal Stem Cells (MSCs) from umbilical cord in the treatment of 7 knee OA patients by assessing unexplained local and systemic symptoms or death before and at 1, 2, 3, 6 months after the injection.

This is a single group assignment study with a total of 9 knee osteoarthritis patients participants. All of the patients will receive the anticular injection with MSCs from umbilical cord and unexplained local and systemic symptoms or death before the end of following-up will be assessed to evaluate the safety and efficacy of mesenchymal stem cells from umbilical cord.

Eligibility Criteria:
Inclusion Criteria:

① K / L score of 2-3; ② chronic knee pain; ③ no local or systemic infection; ④ without obvious contraindication of the joint puncture from hematology and biochemical tests; ⑤ informed consent. -

Exclusion Criteria:

① older than 75 years old or less than 18 years old, or without full capacity for civil conduct; ② HIV, hepatitis virus or syphilis virus infection or their serology is positive; ③ BMI index is greater than 30; ④ congenital or acquired knee deformity; ⑤ pregnant or lactating women; ⑥ tumor patients; ⑦ immunodeficiency patients; ⑧ intra-articular drug injection history within 3 months; ⑨ participating in other clinical trials; ⑩ other patients who researchers believe are not eligible for inclusion such as suffering from other concomitant diseases. -
Study of Neurologic Progression With Motexafin Gadolinium and Radiation Therapy (SMART)

The primary purpose of the study is to determine if patients with brain metastases from non-small cell lung cancer treated with Motexafin Gadolinium and whole brain radiation therapy retain their neurologic function and ability to think for a longer time compared to patients treated with whole brain radiation therapy alone.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years old) with radiologically proven parenchymal brain metastases from histologically confirmed non-small cell lung cancer;
* KPS score of ≥70;
* Each patient must sign a study-specific Informed Consent form

Exclusion Criteria:

* Liver metastases;
* Extracranial metastases in two or more organs;
* Known leptomeningeal metastases or subarachnoid spread of tumor;
* Prior whole brain radiation;
* Plan to use radiosurgery or radiation boost after completion of WBRT;
* Planned chemotherapy during study treatment (prior and subsequent chemotherapy is allowed);
* Prior total resection of a single brain metastasis;
* Laboratory values as follows:

LDH \> 1.3 x upper limit of normal (ULN); ANC \< 1500 /mm³; Platelets \< 50,000 /mm³; Creatinine \> 2.0 mg/dL; AST or ALT \> 2 x ULN; Total bilirubin \> 2 x ULN;

* Women who are pregnant or lactating