cyrilzakka/clinical-trials huggingface dataset:
Psychological and Emotional Impact in Patients Undergoing Treatment For Metastatic Cancer Either in a Clinical Trial or as Standard Off-Trial Therapy

RATIONALE: Gathering information from patients who received treatment for metastatic cancer while participating in a phase II or phase III randomized clinical trial and from patients receiving standard treatment off-trial may help doctors learn more about the psychological and emotional results of being in a clinical trial.

PURPOSE: This clinical trial is comparing the psychological and emotional impact of participating in a randomized clinical trial with the impact of standard treatment in patients with metastatic cancer.

OBJECTIVES:

Primary

* To compare the psychological and emotional consequences in patients who underwent first-line antitumor treatment (chemotherapy or targeted therapy) for metastatic disease while participating in a phase II or III randomized clinical trial vs patients who underwent standard first-line treatment off-trial.

Secondary

* To measure and compare the temporal variation of psychological and emotional consequences during and after completion of or stopping of treatment.
* To measure and compare the degree of knowledge of the implications of participating in a clinical study vs the benefits of standard off-trial treatment and evaluate the impact on psychological and emotional experience.
* To evaluate the relationship between the use of adjustment strategies and emotional regulation and psychological and emotional experiences in both of these situations.

OUTLINE: This is a multicenter study.

Patients complete four questionnaires, including assessment of symptoms of anxiety and depression (HADS), quality of life (QLQ-30), adjustment strategies (WCC), and regulation of emotional behavior (ERQ), during their first course of treatment, after the first evaluation of treatment effectiveness, and one week after completion of treatment. During their first evaluation, patients also complete a questionnaire on the modalities of randomized clinical trials and their impact on care (ICEC-R).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed cancer

  * Metastatic disease for which the median progression-free survival is ≥ 4 months
  * Breast, digestive, kidney, lung
* Receiving first-line antitumor therapy (i.e., chemotherapy or targeted therapy) as part of either:

  * Phase II or III randomized clinical trial
  * Standard treatment off-trial

PATIENT CHARACTERISTICS:

* WHO performance status (PS) 0-3 or Karnofsky PS 50-100%
* No psychological or physical inability to respond to a questionnaire

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No psychotropic treatment, except for antidepressants, anxiolytics, or sleeping pills taken for more than 30 days
Procalcitonin in Early Antibiotic Interruption in Patient With Bacterial Pulmonary infeCtion and Acute Heart Failure

Introduction: Acute Heart Failure is frequently decompensated by pulmonary infection, but the diagnosis of pulmonary infection sometimes is difficult in these patients due to similar signals and clinical symptoms in both pathologies. Furthermore, when it is possible the diagnosis of pulmonary infection, physicians may have difficult to determine etiology and delaying antibiotic therapy. Procalcitonin (PCT) have been used like a biomarker to determine the period of use of antibiotics in patients with acute respiratory infections. It is specific for bacterial infections and it have showed as a marker of severity infection and may help to determine interruption period of antibiotic therapy in a safety way for the patient. Aim: Evaluate levels of PCT related to interruption of antibiotics in patients with decompensated acute heart failure (DAHF) with suspected bacterial pulmonary infection. Methods: In this pilot project will be included around 100 patients, randomized in two groups: group A (PCT levels may guide the interruption of antibiotic at day 5) or group B (antibiotic period will be determined by the physician without the knowledge of PCT levels). Will be collected laboratorial and clinical data at days 0,3 and 5. Both groups will be compared to evaluate PCT levels and total period of antibiotic therapy, hospitalization and readmission in 30 days. This study will determine the sensibility/specificity of PCT in patients with DAHF.

It is a single-center study, randomized, controlled, prospective cohort and interventional not blind. DAHF diagnosis will consider symptoms, physical examination, x ray and other image methods and BNP ou NTproBNP levels. Pulmonary infection diagnosis will "Infectious Disease Society of America / American Thoracic Society Consensus Guidelines on the Management of Community-Acquired Pneumonia in Adults" criteria, that include fever, cough, sputum, pleuritic pain, positive pulmonary image and physical examination. PCT and NTproBNP levels will be measured in miniVIDAS® (bioMérieux Clinical Diagnostics, France). Statistics includes descriptive analysis. Parametric data will be evaluated using T test and non parametric data with Mann-Whitney-Wilcoxon test. Multivariative analysis related to diagnosis, mortality and morbidity will be performed by Cox regression model. Sensibility and specificity will be calculated by ROC curve. Statistical significancy will be considered when p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* DAHF diagnosis and suspected pulmonary infection
* BNP ≥ 500 pg/mL or NTproBNP ≥ 450 pg/mL for patients until 50 years old.
* BNP ≥ 500 pg/mL or NTproBNP ≥ 900 pg/mL for patients with 51 - 75 years old.
* BNP ≥ 500 pg/mL or NTproBNP ≥ 1800 pg/mL for patients older than 75 years.

Exclusion Criteria:

* Antibiotic use (oral or endovenous) in the last 15 days;
* Acute coronary syndrome;
* Creatinine \> 3,0 mg/dL or hemodialysis;
* Pregnancy;
* Second suspectec infection;
* Suspected pulmonary thromboembolism;
* cancer;
* myocarditis.
Effects of IC With and Without MET on Upper Trapezius Trigger Points

the aim of the study is to check the effects of ischemic compression with and without muscle energy technique on Pain, Range of motion, and Functional Disability on myofascial trigger points in the upper trapezius. In previous studies, Muscle Energy Technique and Ischemic Compression are compared with different conventional and combined therapy approaches, including most of the techniques used to treat Trigger Points in the upper trapezius. No study has evaluated the effects of ischemic compression with and without muscle energy technique on Pain, Range of motion, and Functional Disability on myofascial trigger points in the upper trapezius. The outcome measures are a Numeric pain rating scale, universal goniometer and neck disability index questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Both gender Aged 18 to 50 years (40)
* Participants with active myofascial trigger points in the upper trapezius diagnosed by a senior physiotherapist on the basis of Travel and Simon criteria will be randomly allocated into two clinical groups.
* Taut band having palpable nodule within upper trapezius muscle
* Pain produced in a specific pattern which is radiating in character when firm pressure is applied on trigger points

Exclusion Criteria:

* Trauma (whiplash injury)
* Injury to Cervical Spine
* Cervical Spine surgery
* Cervical Myelopathy and Radiculopathy
* Osteoporosis of the cervical spine
* Cervical myeloma
* Complex regional pain syndrome
* Patients with the H/O any Neurological, Rheumatology and other serious medical illnesses.
CICLOPS Immune Checkpoint Inhibitors Neurotoxicity: Long-term Outcomes, Predictors, and Survival.

Immune-checkpoint inhibitors (ICIs) have radically changed the therapy of cancer in recent years. ICIs promote antitumor immune response inhibiting one of the following immune checkpoints: cytotoxic T-lymphocyte antigen-4 (CTLA-4; ipilimumab), programmed death-1 (PD-1: pembrolizumab, nivolumab, and cemiplimab), and programmed death ligand-1 (PD-L1: atezolizumab, durvalumab, and avelumab). Despite the desired effect as cancer treatment, ICIs can break immune tolerance to self-antigens and induce specific toxicities known as immune-related adverse events (irAEs), that may affect both peripheral and central nervous system (Neurological immune mediated adverse events, NirAEs). The pathogenic mechanisms underlying NirAEs are probably heterogeneous, as reflected by the variety of clinical phenotypes and severity.

NirAEs are rare, but there is some concern that the incidence may increase in the next future, in particular because ICIs are being used more and more for cancers commonly associated with paraneoplastic neurological syndromes (e.g. small-cell lung cancer). Moreover, NirAEs are usually severe, and often fatal. Indeed, irAEs-related complications are the most common cause of death among these patients. On the other hand, these patients usually have a good tumor response to immunotherapy. There is some evidence that irAEs may predict ICIs efficacy and consequently NirAE surivors are likely to have longer life expectancy than non-NirAE patients.

Therefore, it is of utmost importance to better characterize the long-term outcomes of NirAE patients in terms of neurologic disability and mortality, and to identify predictors of severe NirAEs. So far, only few studies with sufficient follow-up have been published on the topic, and they included only small number of patients.

The aims of our study is to characterize the main clinical and paraclinical features of NirAEs in a large cohort of NirAE patients, to assess long-term outcomes and to identify prognostic factors. This study will help define new guidelines regarding NirAE prediction and management.


Eligibility Criteria:
Inclusion Criteria:

* patients who developed NirAEs (grade severity equal or more than 3 according to CTCAE)

Exclusion Criteria:

* alternative better explanation for neurological symptoms (cancer progression, carcinomatous meningitis, complications of other treatments..)
Real-world Study of Sunvozertinib Treatment in Advanced EGFR-Mutant NSCLC After EGFR-TKI Treatment Failure

Observe the efficacy and safety of sunvozertinib in the real world in the treatment of EGFRm aNSCLC patients with previous EGFR-TKI treatment

Locally advanced or metastatic NSCLC with EGFR-sensitive mutations who have been previously treated with EGFR-TKIs and PD for last therapy can be involved in this study. Investigators will assess patients whether to be suitable for sunvozertinib treatment. And this study will evaluate the safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. To provide a signed and dated, written informed consent.
2. Age ≥ 18 years old
3. Histologically or cytologically confirmed non-squamous NSCLC with documented EGFR mutations from a local laboratory
4. EGFR-sensitive mutations including exon 19 deletion and exon 21 L858R mutated，at least one line chemotherapy and progress again
5. Predicted life expectancy ≥ 12 weeks
6. Adequate organ system function:
7. Patient must have measurable disease according to RECIST 1.1. -

Exclusion Criteria:

1. Spinal cord compression or meningeal metastasis
2. Not Recover from AEs caused by previous treatment yet
3. A history of stroke or intracranial hemorrhage within 6 months prior to initial dosing.
4. Any severe or poorly controlled systemic disease per investigator's judgment .active infections, including but not limited to hepatitis B (HBV), hepatitis C HCV, and human immunodeficiency HIV
IMRT Plus Cisplatin Versus IMRT in Patients With Stage 2 Nasopharyngeal Carcinoma

Nasopharyngeal carcinoma has high incidence in the southern China, especially in Guangdong Province. In the world, the standardized morbidity has reached 30/10 million in men while in women, about 13/10 million. At present, the incidence of nasopharyngeal carcinoma in China accounted for more than 80% of the world. The cancer-related deaths is in the eighth, which is a serious threat to our people's health and life. A recent multi-center phase II study of stage II nasopharyngeal carcinoma showed that: compared with Intensity Modulation Radiotherapy (IMRT) plus cisplatin, the 3 year local control rate, regional control rate, distant metastasis-free survival rate and disease-specific survival rate of IMRT were similar, but the side effects of radiotherapy alone group were lower.

Based on the results of the phase II clinical study, the investigators designed this phase III clinical study, with the aim to compared the efficacy and toxicity of these two treatment programs. And finally to provide sufficient evidence for the treatment of stage II nasopharyngeal carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* The sex of the subject is not limited, the age is from 18 to 70 years old;
* Histologically proven nasopharyngeal squamous cell carcinoma, World Health Organization (WHO) II-III type;
* Union Internationale Contre le Cancer(UICC) stage 9 clinical stage II patients；
* Karnofsky score ≥ 80 points;
* No evidence of distant metastasis;
* Having an nasopharyngeal MRI before treatment ,which can measure the size of the tumor in order to analyze the effect.

Exclusion Criteria:

* The subject had previously suffered from other malignancies (except non-melanotic skin cancer or cervical carcinoma in situ);
* Previously received immunotherapy;
* Previously received chemotherapy;
* Previously received radiation therapy;
* Patients who had previously undergone surgical treatment for head and neck tumors (excluding cervical lymphadenectomy);
* Evidence of distant metastases or other malignancies at the same time.
GVHD Prophylaxis With Post-transplantation Bendamustine in Refractory Leukemia

Several groups have demonstrated very low incidence of acute and chronic graft-versus-host disease (GVHD) with post-transplantation cyclophosphamide (PTCy) in haploidentical, unrelated and related allogeneic stem cell transplantation (SCT). Nonetheless for majority of the grafts, except for 10/10 HLA-matched bone marrow, with this type of prophylaxis require concomitant administration of calcineurin inhibitors±MMF, which delays immune reconstitution and development of graft-versus-leukemia (GVL) effect. So, despite reduction of transplant-related mortality, use of PTCy doesn't lead to the reduction of relapse incidence. This is particularly important for relapsed or refractory acute leukemia patients, where, despite all efforts to intensify conditioning regimens, relapses after SCT occur in more than 50% of patients, and long-term survival rarely exceeds 10-20%. In preclinical model of haploidentical SCT the substitution of post-transplantation cyclophosphamide with bendamustine, led to comparable GVHD control, but significantly augmented GVL effect. To test this hypothesis and improve the outcome of allogeneic SCT in refractory acute leukemia patients we initiated a pilot trial with high-dose post-transplantation bendamustine for GVHD prophylaxis. The selection of doses is based on the previous dose-escalation studies. Additional immunosuppression could be added for mismatched grafts.


Eligibility Criteria:
Inclusion Criteria:

- Diagnosis: Acute Myeloblastic Leukemia Acute Lymphoblastic Leukemia Mixed-Lineage Acute Leukemias

* Disease, refractory to at list one course of induction chemotherapy or immunotherapy
* More than 5% clonal blasts in the bone marrow or peripheral blood at the time of inclusion
* Signed informed consent
* Matched related, 8-10/10 HLA-matched unrelated or haploidentical donor available. The HLA typing is performed by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.
* No second tumors
* No severe concurrent illness
* No previous autologous or allogeneic stem cell transplantations

Exclusion Criteria:

* Karnofsky index \<70%
* Moderate or severe cardiac dysfunction, left ventricular ejection fraction \<50%
* Moderate or severe decrease in pulmonary function, FEV1 \<70% or DLCO\<70% of predicted
* Respiratory distress \>grade I
* Severe organ dysfunction: AST or ALT \>5 upper normal limits, bilirubin \>1.5 upper normal limits, creatinine \>1.5 upper normal limits
* Creatinine clearance \< 60 mL/min
* Uncontrolled bacterial or fungal infection at the time of enrollment, defined by CRP level \>70 mg/L or positive procalcitonin in patient with adequate empirical antibacterial and antifungal therapy.
* Requirement for vasopressor support at the time of enrollment
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign informed consent
Heparin Antagonization by Protamine in Cardiac Surgery: Pharmacokinetic/Pharmacodynamic Study

Protamine is currently used during cardiac surgery to neutralize unfractionated heparin (UFH) at the end of extra-corporeal circulation (ECC). The optimal dose of protamine is currently unknown, and the administration of protamine is done empirically.

Protamine and UFH pharmacokinetics are characterized by a large inter-individual variability. A dose of protamine proportional to the amount of UFH administrated during the surgery may be therefore not adapted to most of the patients and exposed them to a risk of under or over dosage.

In this study, research investigators hypothesize that an accurate characterization of the pharmacokinetic/pharmacodynamic (PK/PD) relationship of protamine may help to optimize propose an optimal dosing regimen.


Eligibility Criteria:
Inclusion Criteria:

* Patients benefiting from scheduled or emergency at the Saint-Etienne University Hospital (coronary artery bypass grafting, valve replacements, aortic dissections).

Exclusion Criteria:

* Patients with a contraindication to UFH
* Patients with a contraindication to protamine
* Patients requiring early resurgery.
* Patients receiving an injection of antithrombin III.
* Pregnant women.
* Patient for whom aprotinin use is planned during surgery.
A Study of [14C]-LOXO-783 in Healthy Adult Participants

The main purpose of this study is to evaluate how much of the study drug, the radioactive substance 14C incorporated LOXO-783 (\[¹⁴C\]-LOXO-783) passes from blood into urine, feces and expired air in healthy adult participants when administered as a single dose. The study will also measure how much of the LOXO-783 and \[¹⁴C\]-LOXO-783 gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts and will last up to approximately 72 and 61 days for part 1 and 2, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants in good health, determined by no clinically significant findings from medical history, physical examination, ECGs, vital signs, and clinical laboratory evaluations as assessed by the investigator
* Have a body mass index within the range 18.5 to 32.0 kilograms per meter squared (kg/m²)
* Female participants of non-childbearing potential and male participants who follow standard contraceptive methods

Exclusion Criteria:

* History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
* Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
Ursodeoxycholic Acid in Bariatric Surgery

In an open-label trial, 20 otherwise healthy morbidly obese patients scheduled for bariatric surgery will be administered 20 mg/kg/day ursodeoxycholic acid for three weeks until the day before surgery. The maximum dose will be 3 g/day. Twenty other patients will serve as controls. Serum from days 1 and 21 will be analyzed for routine liver tests, bile acids, a complete lipid profile including FA and in addition for 7α-hydroxy-4-cholesten-3-one and fibroblast growth factor 19 (FGF-19), markers for bile acid synthesis its intestinal stimulation. For the evaluation of insulin resistance and possible pre-diabetes, plasma will be taken for the estimation of homeostasis model assessment (HOMA) index and oral glucose tolerance test (OGTT) will be performed at days 1 and 21. At surgery, a liver biopsy (0.5-1 g) and a white adipose tissue (WAT) specimen (1 cm2) will be taken and immediately frozen in liquid nitrogen for messenger ribonucleic acid (mRNA) and protein preparation for quantitative real-time polymerase chain reaction (RT-PCR) and Western analysis, respectively, histopathological Non-alcoholic fatty liver disease (NAFLD) grading, and measuring of hepatic and white adipose tissue (WAT) lipase activity. In all patients at randomization, abdominal ultrasound will be performed for the detection of NAFLD and gallstones and a blood sample will be taken for the analysis of polymorphisms of hepatic lipid synthesis, storage, fatty acid (FA) oxidation and export genes. Six month after operation, HOMA, OGTT and abdominal ultrasound will be repeated.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 35 kg/m2
* Patients eligible to bariatric surgery
* Patients should have given their written consent to participate in this study

Exclusion Criteria:

* Chronic liver disease other than NAFLD (viral hepatitis, autoimmune liver disease, hemochromatosis, homozygous alpha1-antitrypsin deficiency and Wilson disease)
* Partial ileal bypass
* Inflammatory bowel disease
* Uncontrolled diabetes mellitus (fasting blood glucose \> 6.7 mmol/L), hypothyroidism or hyperthyroidism, or other significant endocrine disease.
* A subject who is euthyroid on a stable replacement dose of thyroid hormone is acceptable provided the TSH is within normal range.
* Other serious disease
* Known hypersensitivity to ursodeoxycholic acid
* Patients who will not comply with the protocol.
Digital Analysis of Occlusal Force Distribution in Single-Tooth Implant Restorations

This study will explore the impact of single tooth implant restorations upon occlusal force distribution and the accuracy of several digital analysis methods. The biomechanical behavior of implant-supported prostheses differs from that of natural teeth, and the distribution and modulation of occlusal forces are unpredictable.

The research used the Medit i700 intraoral scanner and the OccluSense system to take pre- and post-implant measurements. The research aims to determine: How are the techniques different in the registration of occlusal contacts and force magnitude? and How does occlusal balance shift following the placement of an implant? The research findings can be used to provide clinical recommendations to optimize occlusal balancing during implant prosthetics.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 and over
* Patients with good periodontal health
* Patients with a Class I bite
* Patients with a single tooth deficiency in the posterior region planned for rehabilitation with an implant-supported single crown restoration

Exclusion Criteria:

* History of temporomandibular joint disease
* Acute pain or signs of occlusal dysfunction
* Restricted mouth opening
* Absence of a tooth distal to the planned restoration
* Occlusion instability due to prior orthodontic or surgical treatments