cyrilzakka/clinical-trials huggingface dataset:
Irradiation Modulates the Pharmacokinetics of Anticancer Drugs for Head and Neck Cancer

The concurrent use of chemotherapy during radiation therapy (CCRT) is now the important treatment stratagem for locally advanced head and neck cancer or nasopharyngeal cancer (NPC). For these cases, 5-Fluorouracil (5-FU) and cisplatin (CDDP) are the most commonly used agents of CCRT. It plays an important role to improve the treatment outcome and increases the opportunities for organ preservation.

In the past, Radiotherapy (RT) was solely used as a local treatment and its effect was estimated by local effect model. However, growing evidence shows that irradiation has direct DNA damage-dependent effects as well as sending signals to neighboring cells. Recently, the investigators reported that abdominal irradiation could significantly modulate the systemic pharmacokinetics of 5-FU at 0.5 Gy, off-target area in clinical practice, and at 2 Gy, the daily treatment dose for target treatment in an experimental rat model. Additionally, the results from a clinical investigation showed that colorectal cancer patients with lower AUC of 5-FU during adjuvant chemotherapy had lower disease-free survival. Taken together, these lines of evidence support the importance and necessity to search for the mediators responsible for the unexpected effect of local RT on systemic pharmacokinetics of chemotherapeutic agents, such as 5-FU.

In the present study, the investigators examined whether the phenomena and mechanism of RT-PK(pharmacokinetics) is a fact for different anticancer drugs and for different part in human.


Eligibility Criteria:
Inclusion Criteria:

* locally advanced head and neck, nasopharyngeal cancers, who prepares for concurrent chemoradiation therapy as definitive or adjuvant setting

Exclusion Criteria:

* previous cancer history；abnormal function of liver and kidney, immunol disease or hematologic disease
The Difference in the Biological Characteristic Characteristics of the Heart and Lung Meridians

The association between viscera and the body surface remains obscure, but a better understanding of it will maximize its diagnostic and therapeutic values in clinical practice. Therefore, this study aimed to investigate the specificity of the association between viscera and the body surface in the pathological state.

Study subjects included 40 chronic obstructive pulmonary disease (COPD) participants in the COPD group and 40 age-matched healthy participants in the healthy control group. Laser doppler flowmetry, infrared thermography, and functional near-infrared spectroscopy were respectively adopted to measure (1) the perfusion unit (PU), (2) temperature, and (3) regional oxygen saturation (rSO2) of 4 specific somatic sites distributing in the heart and lung meridians. These 3 outcome measures reflected the microcirculatory, thermal and metabolic characteristics of the body surface, respectively.

Eligibility Criteria:
Inclusion Criteria:

* COPD participants were eligible if they 1) satisfied the diagnostic criteria of COPD; 2) were in the stable phase of COPD; 3) were 20 ≤ age ≤ 75 years; 4) fully understood the study protocol and signed the written informed consent. Healthy participants were eligible if they 1) were healthy subjects who provided a medical examination report within 6 preceding months for confirming their health conditions; 2) were age-matched with the COPD group; 3) fully understood the study protocol and signed the written informed consent.

Exclusion Criteria:

* COPD patients were excluded if they 1) had other major lung diseases, such as bronchiectasis, pneumothorax, and lung tumors; 2) had concomitant heart diseases; 3) had serious concomitant diseases in major systems that were not controlled effectively 4) had mental diseases, history of drug abuse, and alcohol dependence; 5) were lactating or pregnant and 6)had scarring, hyperpigmentation, redness, swelling and heat in the skin around the measurement sites, which would affect the accuracy of examinations. Healthy subjects were excluded if they 1) had mental illness, history of drug abuse and alcohol dependence; 2) were lactating or pregnant; 3) had scarring, hyperpigmentation, redness, swelling, and heat in the skin around the measurement sites, which would affect the accuracy of examinations.
A Study of RO5083945 in Combination With Chemotherapy Versus Chemotherapy Alone in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

This open label, 2-part study will evaluate the safety and efficacy of RO5083945 in combination with standard chemotherapy in patients with advanced or recurrent non-small cell lung cancer who have not received prior chemotherapy. In Part 1 patients will receive RO5083945 intravenously and standard chemotherapy (cisplatin plus either gemcitabine or pemetrexed) for up to 6 cycles of 3 weeks and then RO5083945 until disease progression. In Part 2 patients will be randomized to receive either RO5083945 in combination with standard chemotherapy or chemotherapy alone for up to 6 cycles. In the absence of disease progression, patients receiving RO503945 can continue treatment with RO5083945 as monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Advanced (IIIb), metastatic (IV) or recurrent non-small cell lung cancer
* At least 1 measurable disease lesion as per RECIST criteria
* Confirmed presence of EGFR in tumor tissue
* ECOG performance status 0-1
* Adequate hematological, renal and liver function

Exclusion Criteria:

* Prior chemotherapy or treatment with another systemic anti-cancer agent
* Radiotherapy within the last 4 weeks, except for limited field palliative radiotherapy for bone pain relief
* Symptomatic or active CNS metastases
* Recent history of poorly controlled hypertension (systolic \>180mmHg or diastolic \>100mmHg)
* Requirement for steroids \> 40 mg prednisolone
Edaravone in the Treatment of Optic Neuritis

Edaravone has demonstrated a beneficial effect in promoting remyelination and protecting axons in animals with NMOSD. The researchers posit that edaravone may enhance visual outcomes in patients with aquaporin-4 antibody-positive optic neuritis.


Eligibility Criteria:
Inclusion Criteria:

1. Chinese patients aged ≥18 with anti-aquaporin-4 antibody-positive optic neuritis
2. Patients with a first episode of optic neuritis in either eye
3. First symptoms of optic neuritis ≤30 days prior to the first administration of edaravone

Exclusion Criteria:

1. Myopia over 6 diopters
2. Refractive media opacity affecting assessment of retinal layers and/or visual acuity
IOLMASTER 700 Central Topography Workflow Study.

The use of ocular biometers like IOLMaster 700, is a common practice to identify several ocular parameters such as the keratometry of the cornea and the axial length of the eye, which are necessary for calculating the power of the intraocular lens in cataract surgery. However, the additional use of other devices, such as Cassini and Pentacam is used to obtain more information of the central topography of the eye. Recently, a new version of the IOLMaster 700 equipment that provides much more detailed information than in its previous version has been presented. The objective of this study is to measure the time that the new IOLMaster 700 takes to perform these measurements of the central topography and compare it with the time it takes using the central topography using the standard IOLMaster 700 version with Cassini on one hand and Pentacam on the other.

It is hypothesized that the use of the new version of the IOLMaster 700 equipment alone can reduce the time of measurements and improve the clinic workflow.


Eligibility Criteria:
Inclusion Criteria:

* Patients that have to undergo a cataract surgery
* Patients older than 50 years.

Exclusion Criteria:

* Patients that have already undergone a previous corneal surgery.
* Patients suffering from keratoconus.
* Patients exhibiting corneal scars
* Patients exhibiting pterygium
Rituximab Plus Cyclophosphamide in Treating Patients With Indolent Stage III or Stage IV Non-Hodgkin's Lymphoma

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy and monoclonal antibody therapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab plus cyclophosphamide in treating patients who have indolent stage III or stage IV non-Hodgkin's lymphoma.

OBJECTIVES: I. Determine the toxicity associated with cyclophosphamide and rituximab (IDEC-C2B8 monoclonal antibody) as first line treatment in patients with stage III or IV indolent B-cell lymphoma. II. Determine the objective tumor response rate and duration of response associated with this first line treatment in these patients. III. Determine the failure-free and overall survival for these patients. IV. Compare the response rate and survival rates for patients with indolent lymphoma who were treated with this treatment as the first systemic therapy for their disease with response rates and survival observed for similar patients treated in published trials. V. Determine the quality of life associated with this treatment in this patient population.

OUTLINE: This is an open label study. Patients receive oral cyclophosphamide daily and rituximab (IDEC-C2B8 monoclonal antibody) IV on days 1, 8, 15, and 22 for the first 4-week course. Patients then receive oral cyclophosphamide daily and rituximab IV monthly until 2 months beyond maximum response. Patients are treated for at least 6 months but no more than 18 months in the absence of disease progression. Patients are followed every 3 months for 2 years, then every 6 months for the next 2 years, and then annually for up to 10 years.

PROJECTED ACCRUAL: There will be 20-40 patients accrued into this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV indolent B-cell lymphoma Diffuse small cleaved cell lymphoma Follicular small cleaved cell lymphoma Follicular mixed cell lymphoma Follicular large cell lymphoma At least 1 lymph node or visceral lesion at least 2 cm in diameter

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Lymphocyte count less than 5,000/mm3 Hepatic: Not specified Renal: Not specified Other: No active infection No concurrent life threatening disease Not pregnant Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: No prior therapy for lymphoma
Heart Rate Variability, Vagus Nerve and Cancer

In France, new cancer cases keep on increasing with around 150 000 deaths yearly. Cancer therapy research is constantly evolving. Indeed, several studies explore new treatments or their combination with conventional cancer treatments. But, at the same time, complementary and alternative medicines, as osteopathy, remain little explored upon their role in the combination with conventional therapy.

Several studies showed indirect interaction between vagus nerve and cancer. Firstly, vagus nerve regulates homeostasis and immunity by reducing systemic inflammation while maintaining local inflammation and antitumor effects. Secondly, vagus nerve stimulation increases Heart Rate Variability (HRV). Moreover, a higher HRV is associated with an improvement of vital prognosis in cancer patients. Vagus nerve could be stimulated by noninvasive osteopathic manipulations.

This prospective, monocentric and randomized study is a collaboration between the Centre Hospitalier d'Avignon and the Institut de Formation en Ostéopathie du Grand Avignon. It focuses on using noninvasive osteopathic mobilizations to stimulate vagus nerve. Indeed, this study aims to evaluate effects of vagus nerve osteopathic stimulations on HRV in patients with lung cancer, colorectal cancer, Non Hodgkin Lymphoma or Multiple Myeloma. More specifically, this study will tell us whether vagus nerve noninvasive osteopathic stimulations induce increase of HRV associated with a decrease of systemic inflammation and an improvement of patient's quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patient with lung cancer or colorectal cancer or Non Hodgkin Lymphoma or Multiple Myeloma (Stade I à IV)
* No previous treatment
* HRV \< 70 ms
* No osteopathic contraindication

Exclusion Criteria:

* Vagotomy
* Heart arrhythmia
* Cancer recurrence
* Consumption of coffee or tabac within 2 hours prior osteopathic treatment
* Consumption of alcohol within 24 hours prior osteopathic treatment
Research for Individualized Therapeutics in Rare Genetic Disease

The purpose of this research study is to identify individuals that have a rare genetic disease without an adequate therapeutic strategy that might be treatable with drug developed to target the disease-causing genetic alteration.


Eligibility Criteria:
Inclusion Criteria:

* Has Mayo Clinic or other medical health system ID, or another unique identifier.
* Able to provide informed consent.
* Individual must have evidence of a genetic disorder as determined by a provider or genetic counselor with causative or likely causative genetic variants identified by molecular testing.
* Genetic variants must be hypothesized to be targetable using antisense oligonucleotide drugs (such as: knockdown gain of function alterations, increase protein production for reduced function alterations, or modulate mRNA splicing to correct abnormal splicing, promote normal splicing, or return reading frame to an out-of-frame transcript to restore function, etc.) based on current acceptable understanding of ASO mechanisms of action and tissue/organ targeting efficiency.
* Biological family member of an enrolled individual.
* Would be able to travel to a Mayo Clinic site for ongoing treatment should a therapeutic be developed.
* Treatment at the individual's current disease state would likely provide benefit based on current clinical data and understanding of the progression of the disease.

-Or-

* Biological family member of an enrolled individual
* Able to provide informed consent or has a LAR available to provide informed consent

Exclusion Criteria

* Individuals who have situations that would limit compliance with the study requirements.
* Institutionalized (i.e. Federal Medical Prison).
Late Cardiac Evaluation of the Three Arm Belgian Trial Involving Node-positive Early Breast Cancer Patients

Late Cardiac Evaluation of the Three Arm Belgian Trial A phase III randomized trial involving node-positive early breast cancer patients with a long median follow-up (\~ 15 years)

OBJECTIFS

Primary:

• To compare the incidence of late cardiac events between anthracycline and non-anthracycline chemotherapy given to node-positive breast cancer patients in the Belgian three arm randomized clinical trial

Secondary:

* To compare the late incidence of cardiac events between higher and lower dose anthracycline treated node-positive breast cancer patients;
* To compare anthracyclines (higher and lower doses) and non-anthracycline chemotherapy for:
* left ventricular diastolic function assessed by Echo
* exercise capacity assessed by 6-minute walk test (6MWT)
* cardiac morphology (myocardial inflammation or injury, fibrosis, LVEF) assessed by MRI
* serum cardiac biomarkers (BNP and TNT)
* patient-reported cardiac symptoms
* patient-reported cardiac symptoms assessed by QOL questionnaires are associated with subclinical findings on LVEF assessment
* cognitive function, functional autonomy, and psychological distress

The primary objective of this study is to compare the incidence of cardiac events \[(defined as asymptomatic systolic dysfunction (LVEF \< 50%, asymptomatic NYHA I) or symptomatic heart failure NYHA class II-IV either by Echo and/or by clinical exam (LVEF \< 50% and heart failure symptoms)\] between anthracycline and non-anthracycline chemotherapy treated node-positive breast cancer patients in a long-term follow-up. We will define a binary status for each patient: no cardiac event / one or more cardiac events. Analysis of the primary endpoint will involve a comparison of the CMF-treated patients versus the pooled anthracycline treated patients (EC and HEC). If a significant difference is detected, all paired comparisons will also be performed for the primary endpoint (CMF versus EC, CMF versus HEC, EC versus HEC).

Eligibility Criteria:
Inclusion Criteria:

* Alive, free of any recurrence, Not lost to follow-up
* Last workup should be no older than 1 year to exclude relapses. If this is older than 1 year, a new workup (PE, blood tests and MMG) will be performed prior to the entry in this study
* Patients previously diagnosed with CHF who are free of recurrence will also be invited to participate, if there is no contra-indication
* Patients should be able to perform the prescribed assessments

Exclusion Criteria:

* Death
* Breast cancer recurrence
* Unwilling to perform exams as per protocol
Cardiac Output and Recovery Time

The purpose of this research is to determine the time it takes to reverse the effects of the intraoperative medication given to relax the muscles and how this period of recovery correlates with a function of the heart.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years old.
* Patients willing to participate and provide an informed consent.
* Patients undergoing an elective surgical procedure requiring administration of rocuronium, and the use of a pulmonary artery catheter intraoperatively.

Exclusion Criteria:

* Patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture.
* Patients with systemic neuromuscular diseases such as myasthenia gravis.
* Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.
* Patients having surgery that would involve prepping the arm or leg into the sterile field.
"Real Life" Evaluation of Efficacy and Safety of Direct Antiviral Agents (DAAs) for the Treatment of Hepatitis C Virus in Egypt

The primary purpose of the ANRS 12332 HepNile study cohort is to assess in "Real-Life" condition the efficacy and the safety profile of new Direct Acting Antivirals (DAAs) introduced in the Egyptian National Treatment Programme for the treatment of Chronic Hepatitis C (CHC).

Clinical trials are performed under optimal conditions where patients are highly selected with no co-morbidity, clinical supervision is provided by the best specialists in the field, and strict protocols are used to enhance patients' compliance. Thus, results may not be generalizable to real-world clinical practice.

Observational studies are now gaining attention, showing with previous treatments (combined pegylated interferon and ribavirin) a wide range of results in terms of treatment effectiveness (SVR from 21% to 63% overall), whereas related pivotal clinical trials had estimated SVRs between 54% and 63% overall.

Egypt is the first low/middle-income country where a national treatment program has been established on a large scale, allowing an evaluation that might be useful to itself and other similar countries. A real life evaluation will be particularly relevant now that new anti-viral drugs, direct-acting antivirals, are being introduced in Egypt.

ANRS 12332 HepNile cohort study will allow "in real life condition" the study of:

* Efficacy (cure rate) and safety of new HCV regimens introduced in Egypt
* Emergence of resistance variants for patients with virological breakthrough
* Factors associated with treatment failure
* Drug-Drug interactions
* Adherence to the treatment regimens

Eligibility Criteria:
Inclusion Criteria:

* HCV RNA positivity
* 18 years =\< Age =\< 70 years
* Patients \>= 65 years should undergo cardiological assessment prior to therapy by ECG echocardiography and cardiological consultation
* Effective contraception (Women of childbearing potential should use an effective contraception; Male patients and their female partners must also practice effective contraception) both during treatment and for the 3-months post-therapy); no breast-feeding
* Signed informed consent and willingness to participate in the study

Exclusion Criteria:

* Child C cirrhotic patients
* Platelet count \> 50000/mm3
* Hepatocellular Carcinoma (HCC), except 6 months after intervention aiming at cure with no evidence of activity by dynamic imaging (CT or MRI)
* Extra-hepatic malignancy except after two years of disease-free interval (in case of lymphomas and chronic lymphatic leukemia, treatment can be initiated immediately after remission)
* Pregnancy or inability to use effective contraception
* inadequately controlled diabetes mellitus (HbA1C\>9%)
Success Rate of Anterior Middle Superior Alveolar (AMSA) Nerve Block in Three Different Sites of Injection

AMSA nerve block injection is targeted anterior superior alveolar nerve and middle superior alveolar nerve branches of infraorbital nerve through nutrient canals. Therefore, central to second premolar teeth of one quadrant can be anesthetized. The aim of the present study was to evaluate the efficacy of AMSA nerve block injection at an anterior and a posterior positions compared to commonly administrated site.

AMSA: Anterior middle superior alveolar

Eligibility Criteria:
Inclusion Criteria:

* Healthy subject
* Subjects had all their maxillary teeth from second premolar of one side to the second premolar of another Neither of these teeth was non vital, nor had large restorations, prosthetic crowns, caries, periodontal disease, history of trauma, and hypersensitivity.

Exclusion Criteria:

* Use medications alleviating or altering the pain sensation
* Allergy to anesthetics Pregnancy
A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition

This study is researching an investigational drug, ALN-HSD called "study drug". This study is focused on participants who are known to have metabolic dysfunction-associated steatohepatitis (MASH). MASH is a form of metabolic dysfunction-associated steatotic liver disease (MASLD). MASH occurs when fat builds up in liver cells, damaging them, and making the liver inflamed and stiff from fibrosis (scar tissue). MASH can progress to cirrhosis (long term scarring) and liver failure (when the liver cannot perform its job). The aim of the study is to see the effect of the study drug on lessening liver scarring side effects related to MASH.

The study is looking at several other research questions, including:

* How ALN-HSD works to improve liver function and lessen MASH-related inflammation in the liver
* What side effects may happen from receiving the study drug
* How much study drug and study drug metabolites (byproduct of the body breaking down the study drug) are in the blood at different times
* Better understanding of the study drug and MASH


Eligibility Criteria:
Key Inclusion Criteria:

1. Adult male or female ≥18 years (or country's legal age of adulthood)
2. A diagnosis of MASH with fibrosis (F) stage 2 or 3, according to the NASH-Clinical Research Network (CRN)
3. NAS score ≥3, as defined in the protocol
4. Meets genotype criteria for study enrollment, as defined in the protocol
5. Has protocol defined FibroScan®-AST (FAST) score at screening or within approximately 12 weeks of screening

Key Exclusion Criteria:

1. Evidence of other forms of known chronic liver disease, as defined in the protocol
2. Known history of alcohol or other substance abuse within the last year or at any time during screening, as defined in the protocol
3. History of Type 1 diabetes
4. Bariatric surgery within approximately 5 years prior to or planned during the study period
5. Prior exposure to any investigational drug targeting HSD17B13 or patatin-like phospholipase domain containing 3 (PNPLA3) (eg, ALN-HSD, ARO-HSD, ALN-PNP, AZD2693)

Note: Other protocol-defined Inclusion/Exclusion Criteria apply