cyrilzakka/clinical-trials huggingface dataset:
Immunomonitoring and Biomarker Research in Patients With Squamous Cell Anal Carcinoma

Even if squamous cell carcinoma of the anal canal (SCCA) is a rare disease, its incidence increases worldwide. SCCA is mostly induced by Human papillomavirus (HPV) infections and HPV-related oncoproteins (E6 and E7) are expressed in more than 90% of SCCA. T stage and N stage are recognized prognostic factors for local and/or distant recurrence in SCCA patients treated by chemoradiotherapy. In fact, ≥T3 or ≥N1 anal cancers are associated with as high as 50% of disease recurrence rate at 2 years.

The University Hospital of Besançon with the Gercor conducted a prospective clinical trial (Epitopes HPV02 study) including 69 advanced SCCA patients and established a new standard of care based on Docetaxel, Cisplatin and 5-FU (5-FluoroUracil) chemotherapy (DCF). Among 69 patients treated with DCF regimen, 66 patients were evaluable for efficacy end-points. The objective response rate was 86% including 44% of complete response, and 47% of patients were progression-free at 12 months of follow-up from the first cycle of DCF treatment. Thus, the "Epitopes-HPV02" trial has demonstrated a high response rate of the DCF regimen with a higher than expected 12 months progression-free survival rate.These results raised the hypothesis of DCF being an immunogenic chemotherapy and in that demonstrating a possibly new role of taxane-based chemotherapy in SCCA patients. More than 50% of patients in complete remission had a detectable immunological response against peptides derived from HPV oncoproteins (E6 or E7) or from the telomerase antigen (which is transactivated by E6).

LAND study will enroll patients with locally advanced SCCA enrolled in OPTIMANAL clinical trial. OPTIMANAL study will assess the feasibility and efficacy to combine nivolumab to mDCF chemotherapy, followed by the standard chemo-radiotherapy, in high risk locally advanced SCCA patients with T3/T4 N1a or N1b/N1c disease.

LAND study is an exploratory translational study, which will analyze the biological mechanisms of action and our ability to track the immune responses against HPV and telomerase. The investigator group will take advantage of the presence of HPV antigens in most patients to set up a specific immunomonitoring program based on tumor samples and blood-derived lymphocytes to better understand the potential synergisms between immunogenic chemotherapy and anti-PD1 (Programmed Death-1), and to identify valuable biomarkers of treatment efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age ≥18 years,
2. Patients enrolled in OPTIMANAL trial
3. Signed and dated informed consent for LAND-translational study
4. Histologically proved squamous cell anal carcinoma.

Exclusion Criteria:

1. Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study,
2. Patient under guardianship, curators or under the protection of justice.
Database Creation and Evaluation of Motor Function of Finger Tapping Measured by Magnetic Sensor System in Healthy Subjects

The purpose of this study is to create a database of quantified finger movements. Using the evaluation system with magnetic sensors, the movements of finger tapping are measured and assessed by various indices, such as finger tapping interval, maximum amplitude of finger taps, and so on. In this study, the investigators will accumulate the data from healthy subjects for the purpose of applying this evaluation system to diagnosis support of nervous diseases in the future.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Informed consent signed

Exclusion Criteria:

* Renal or hepatic dysfunction
* Severe heart disease
* Under medications for diabetes or hypertension
* Medical history of nervous disease, mental disease, muscular disease, cervical spondylosis, and/or apoplexy
* Feeling difficulty in daily movements
* Taking medicines which possibly affect the motor function of finger tapping.
* Implantation of pacemaker or DBS
Colposeptine for the Treatment of Bacterial Vaginosis

This is a prospective, randomized, controlled and multi-center trial to assess the use of colposeptine in female subjects with bacterial vaginosis. A total of 480 subjects were planned to be enrolled in various centers in China.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects in reproductive age and older than 18 year
* Subjects with normal sexual activity
* Subjects with symptoms such as vulva-vaginal irritation or abnormal vaginal discharge
* Subjects with Nugent Score greater than or equal to 7
* Subjects who are willing to use contraception
* Subjects who are willing to refrain from the use of other vaginal products throughout the study
* Subjects who sign informed consent form and agree to follow-up on time

Exclusion Criteria:

* Subjects without sexual activity
* Pregnant or lactating female subjects
* Subjects with a history of recurrent bacterial vaginosis
* Subjects diagnosed with trichomonas vaginitis，vulvovaginal candidiasis，chlamydia or gonococcus infection.
* Subjects who are unwilling to refrain from the ingestion of any alcoholic beverages during the 7 day course of oral metronidazole therapy
* Subjects who are under treatment by lithium, phenobarbitone, coumadine anticoagulant, cyclosporine or disulfiram by the time of inclusion (interactions with other products and metronidazole)
* Subjects who are undergoing systemic or topical treatment with antibiotics, steroids, immunosuppressive, cytostatic or antimetabolic agents by the time of inclusion
* Female subjects with a history of peripheral neuropathy
* Female subjects who have participated in another clinical trial or have taken an experimental drug within the past 30 days
* Subjects who are unable to give written informed consent
Feasibility of Radiofrequency Resection in Oropharyngeal Tumor Surgery

In the last years radiofrequency resection has become a frequent method in surgical subspecialties. Although many departments are using this method for the resection of Tumor in the oropharynx, there is no study so far which describes feasibility and safety.

Goal of this study is to show feasibility and safety of Radiofrequency Resection in Oropharyngeal Tumor Surgery.

In the last years radiofrequency resection has become a frequent method in surgical subspecialties. Although many departments are using this method for the resection of Tumor in the oropharynx, there is no study so far which describes feasibility and safety.

Goal of this study is to show feasibility and safety of Radiofrequency Resection in Oropharyngeal Tumor Surgery.

Eligibility Criteria:
Inclusion Criteria:

- 18 years and older benign or malign tumor of the oropharynx tumor must be resectable transorally

Exclusion Criteria:

* Prior radiotherapy or chemotherapy
The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males

To evaluate the safety, tolerability, blood levels and effects of CDP6038 administered by intravenous infusion (iv) and subcutaneous (sc) injection.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 19.0 and 28.0 kg/m² and body weight between ≥ 50 kg and ≤ 120 kg

Exclusion Criteria:

* Previous trial participation or blood donation/loss within 3 months
* Subject is not healthy (eg significant medical history, taking drug treatments, any psychological or emotional problems, or drug or alcohol abuse (current or historical)
* Plans for or actual vaccination within 3 months
* Previous drug treatments
* Tobacco use or heavy caffeine consumption
* Systolic blood pressure \<90 or \>145mmHg, diastolic blood pressure \<40 or \>90mmHg or heart rate \<45 or \>90 beats per minute
Immune and Physical Recovery Following Cesarean Delivery

Pregnancy results in an altered immune state compared to the nonpregnant population. A significant proportion of women undergoing cesarean delivery recover poorly. The first step to determining whether this is an immune driven / associated process is to characterise what effects this surgery has on maternal immune function. "Normal" changes will be evaluated in maternal immune function and activity precipitated by surgery and delivery of the neonate. Immune response to surgery will be compared to historical immune data from patients undergoing non-obstetric surgery (orthopaedic patients).

Variations will be evaluated in baseline and postpartum leukocyte subset distribution and singling pathways within leukocyte subsets (including response to surgery) in women undergoing elective cesarean delivery compare to patients undergoing nonobstetric surgery (orthopaedic data from a completed study). This will help to determine whether baseline immune function and response to trauma (surgery) is the same in the pregnant and non-pregnant states. Women will also be evaluated for clinical recovery parameters using validated scoring measures and objective measurement of physical activity through use of a smartwatch (actigraph) around the peripartum period. This information is of significant importance as it brings us one step closer to identifying immune mechanisms that may be involved in or associated with poorer postpartum recovery.

Aim- to determine whether perioperative immune function can predict women who are likely to have delayed physical recovery or recover poorly as demonstrated by lower scores on subjective clinical questionnaires and collected via watch actigraphy. This will help to determine whether a pre-existing deficient immune state is responsible for a worse recovery profile, which could be identified preoperatively. Similarly whether an impairment in response to surgery is demonstrable, which predisposes women to worse recovery profiles will be evaluated.

Ultimately, earlier identification of at-risk parturients (for example, through a preoperative bedside test) may lead to earlier interventions / patient centred care, in an attempt to improve their recovery trajectory and patient experience.

Eligibility Criteria:
Inclusion Criteria:

* elective cesarean delivery at Lucile Packard Hospital
* age \>20 to \<50 years old,
* single pregnancy term
* gestational age 37-41 weeks pregnancy,
* elective cesarean delivery,
* spinal or combined spinal-epidural anesthesia as primary anesthesia mode,
* multimodal analgesia regimen (including intrathecal morphine and regular acetaminophen and NSAIDs), single center at Stanford.
* ASA grade 1 or 2.
* gestational diabetes (not requiring insulin or diabetes medications and pre-eclampsia (without severe features) will be included.
* ethnic background: all ethnic backgrounds will be included gender: pregnant women only

Exclusion Criteria:

* refusal to participate
The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension

Carvedilol has emerged as the preferred non-selective β-blocker (NSBB) for treating portal hypertension. However, there is still a debate in dosing regimen, specially regarding dose interval, with a potential lower bioavalability in once daily regimens. The aim of this study is to assess the acute effects of carvedilol posology in patients with clinically significant portal hypertension (CSPH), as a surrogate marker of bioavailability.

In this experimental study, patients with CSPH receiving carvedilol twice daily were asked to supress the night dose of carvedilol, in order to have a dose interval of approximately 24 hours. Spleen stiffness measurement (SSM) by transient elastography (TE) was performed and compared with SSM prior or under treatment. Same procedure was applied to liver stiffness measurement (LSM).


Eligibility Criteria:
Inclusion Criteria:

* patients with CSPH (defined as a LSM 25 kPa or SSM over 45kPa prior to introduction of carvedilol)

Exclusion Criteria:

* Non-responders to non-selective β-blockers (NSBB)
* NSBB other than carvedilol
* Dosing regimen other than twice daily
* No SSM or LSM within 3 months prior to the beginning of the study
* Body mass index (BMI) \> 30 m/kg2
* Contraindications to NSBB use
* Portal venous thrombosis
* Refusal to participate in the study
* Failure to comply to the study regimen
Effect of Saturated Fat on Large Low-density Lipoprotein (LDL) and High-density Lipoprotein (HDL)

The purpose of the study is to test whether increased saturated fat intake results in increased levels of larger LDL and HDL particles in individuals with LDL Pattern B.

Increased saturated fat intake is known to elevate plasma levels of both low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C), however, less is know regarding the effect of saturated fat on lipoprotein subclasses. We previously showed that, in the context of a reduced carbohydrate diet, saturated fat induced increases in LDL cholesterol were apparently due to increases in large, more buoyant LDL without increases in small, dense LDL. This finding was supported by a previous dietary intervention study showing a correlation between saturated fat intake and large LDL. In both cases, this increase in large LDL was correlated with an increase in large HDL. In this study, we will test the following specific hypotheses regarding changes in plasma lipoproteins induced by a diet high in myristic acid and other saturated fats derived primarily from dairy sources in individuals with LDL subclass pattern B: 1) there will be a coordinate increase in levels of large HDL particles that are considered anti-atherogenic and large LDL particles that are less strongly associated with increased CVD risk than smaller LDL; 2) this change in lipoprotein profile will result in a higher proportion of pattern B individuals converting to LDL subclass pattern A (predominance of larger LDL); and 3) the coordinate increase in large HDL and LDL is due to a common underlying pathway. The latter hypothesis will be addressed by assaying cholesterol ester transfer protein (CETP), hepatic lipase (HL), and lipoprotein lipase (LPL).

Eligibility Criteria:
Inclusion Criteria:

* Men or postmenopausal woman between 18-70 yrs
* Body Mass Index between 25-35
* Blood pressure \<150/90
* Non smoking
* Agrees to consume no alcohol or dietary supplements during the study
* LDL Subclass Pattern B
* Total cholesterol and LDLC ≤95th percentile for sex and age
* Fasting triglycerides ≤ 500mg/dl
* Fasting blood sugar \< 126 mg/dl
* At least 3 months weight stable

Exclusion Criteria:

* History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin) in the last 5 years
* Taking drugs known to affect lipid metabolism or hormones
* Abnormal thyroid stimulating hormone (TSH)
Acute Coronary Syndrome Sri Lanka Audit Project

ACSSLAP is the first island wide audit project in Sri Lanka on ACS.

Acute coronary syndrome is a leading cause of morbidity and mortality in the world. Even though up-to-date epidemiological data are not available, as per the institutional level experiences this is not differ much in the local settings. Having a free health care system, government of Sri Lanka has to allocate billions of funds and resources from the annual budget for the maintenance of health care system. Being a developing nation this is a considerable burden to the economy of the country. However, prioritization during resource allocation will prevent mal-distribution of limited resources.

Health care system in Sri Lanka should deliver free as well as quality care to the nation. However, lack of updated guidelines in Sri Lanka for the management for acute coronary syndrome (ACS) is a drawback. American College of Cardiology (ACC) and the European Heart Association (EHA) have developed evidence based and most up to date guidelines to standardize clinical practices in the management of ACS. It is recommended to adhere to local or International guidelines to deliver optimal and quality care to ACS patients.

In Sri Lanka, no audits have been conducted in the health sector in relation to patient management practices in the past. Even though institutional level audits have been carried out time to time for the purpose of allocating medicines and other diagnostic resources, island wide large scale audits have not been carried out. Therefore, conducting an audit on health recourse allocation and patient management clinical practices has become a high priority.

Investigators selected ACS as the most important clinical discipline to conduct an audit based on the institutional level data. This audit is included as a well-designed set of clinical criteria derived from the Myocardial Ischemia National Audit Project (MINAP) in UK, SNAPSHOT ACS study in Australia and New Zealand, American College of Cardiology and European Health Association guidelines. These criteria have been extensively reviewed by a panel of cardiologists and physicians to customize it according to the local requirements.

This project will be Coordinated by the Department of Pharmacology, Faculty of Medicine, University of Colombo in collaboration with the Sri Lanka Heart Association, Ceylon College of Physicians and will be carried out through the Quality and safety Unit of the Ministry of Health, Sri Lanka. Funding is sought from the Ministry of Health

Eligibility Criteria:
Inclusion Criteria:

-Patients who are diagnosed with acute coronary syndrome before/after admission to the hospital.

Exclusion Criteria:

* Patient who refuse to give consent
* Patients who are less than 18 years of age
* Patients whose diagnosis later changed to another diagnosis
* Patient who are enrolled in any other study.
Set Your Goal: Engaging Go/No-Go Active Learning

This study will test a computational model reinforcement learning in depression and anxiety and test the extent to which the computational model predicts response to an adapted version of behavioral activation psychotherapy. The model will be based on a data from a computer task of reinforcement learning during 3T functional magnetic resonance imaging at baseline.

The dysfunction of reinforcement learning is emerging as a transdiagnostic dimension of mood and anxiety. Computational models of reinforcement learning may expedite our ability to identify predictors of response, thereby improving efficacy rates. We will will, first, examine the neural substrates of reinforcement learning in depression and anxiety, and, second, test a computational model of reinforcement learning as a predictor of response to an adapted version of behavioral activation psychotherapy. Subjects (N=10) will be enrolled in a two week evaluation, followed with a nine week weekly intervention program. Assessments will be conducted at baseline, and during the intervention as the 3-, 6-, 9-week follow-ups. Reinforcement learning will be measured using 3T magnetic resonance imaging during a computer task. All other measures include structured clinical interviews, questionnaires, and computer tasks.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 21 and 40
* Physically healthy
* Right handed
* Normal or corrected to normal vision
* Scores equal or higher of (a) 24 on Inventory of Depressive Symptomatology, Self Report, or (b) 15 on the Generalized Anxiety Disorder Self Report.

Exclusion Criteria:

* Not currently in therapy or taking medications for anxiety or depression
* No contraindications for the magnetic resonance scan (claustrophobic)
* No history of head trauma, seizures, loss of consciousness
* Not taking hormone replacement, not pregnant
* No imminent suicidality
* No report of excessive alcohol or drug use in past three months
Mycose AdminiStration for HealIng Alzheimer NEuropathy (MASHIANE)

Alzheimer's disease (AD) is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, and, eventually, the ability to function independently. Despite the significant effort to understand the basic biology of the disease and pharmaceutical advances to develop drugs, there is no effective therapy available to treat AD or slow the disease progression.

β-amyloid accumulation outside brain cells and abnormal accumulations of tau protein inside neurons are taught to be two main changes in the brain that lead to AD. Progressive accumulation of β-amyloid interferes with the neuron-to-neuron communication at synapses, contributing to neural cell death. Also, tau tangles block the transport of nutrients and other essential molecules into the neurons. Many molecules have been shown to inhibit amyloid aggregation. The anti-amyloidogenic activity of trehalose was confirmed in both in vitro and in vivo studies and its inhibitory effects on β-amyloid formation in AD have also been demonstrated. Trehalose is a non-toxic disaccharide and no dose-dependent adverse effects were seen in any of the safety studies. It can act as a chemical chaperone and stabilizes the natively folded structure of protein and also trehalose has been identified as an autophagy inducer and promotes the clearance of aggregated proteins. Therefore, trehalose could be a valuable candidate for the treatment and prevention of amyloid-related disease. Based on the proposed hypothesis, this study aim to investigate the potential efficacy of trehalose administration in patients with AD.

Purpose of the study: A randomized, triple-blind, pilot clinical trial has been designed to evaluate the effectiveness of trehalose on reducing the symptoms in AD patients. Study intervention: twenty patients with Alzheimer's disease were randomly divided into an intervention and a control group. Trehalose will be administrated intravenously (15 g/week) for 12 weeks in the intervention group and the control group will be received normal saline as a placebo.

Eligibility Criteria:
Inclusion Criteria:

* Mini-Mental State Examination (MMSE) score range from 10 to 23
* Not having other cognitive disorders

Exclusion Criteria:

* MMSE score higher than 23 or lower than 10
* The presence of other cognitive disorders which will be evaluated by clinical assessment and brain imaging
* The presence of factors affecting cognitive impairment such as depression
* Vascular dementia and Lewy body dementia
* Previous history of head trauma
* Use of alcohol and other drugs that affect cognitive functioning
Seifem Surveillance of Antifungal Combination Therapy In Hematologic Italian Centers

This trial is an observational study about combination antifungal therapy in hematologic patients with proven and probable invasive fungal infections (IFI).


Eligibility Criteria:
Inclusion Criteria:

* Haematologic patients with proven or probable IFI
* Therapy with a combination of antifungal drugs

Exclusion Criteria:

* Haematologic patients with possible IFI