cyrilzakka/clinical-trials huggingface dataset:
Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in Asiatic HCV Patients Resistant to Bitherapy

This study is designed to evaluate the safety of biological active dose of a new experimental drug, IL-7, in combination with standard bi-therapy in Asiatic patients with Hepatitis C chronic infection identified as non responders to the standard bi-therapy alone.

This is a Phase I/IIa inter-patient dose-escalation study assessing weekly doses of Interleukin-7 (CYT107) in Asiatic adult patients infected by virus of genotype 1 of Hepatitis C and resistant to standard treatment with Peg-Interferon and Ribavirin (bi-therapy).

The dose escalation is aimed at establishing the safety of a biologically active doses of CYT107 added to the combination therapy of pegylated interferon-alpha and ribavirin. At each dose level, study patients will receive one subcutaneous administration of CYT107 per week for a total of 4.

Groups of 3 to 6 patients will be entered at each dose level of CYT107. Three dose levels are planned.

Eligible patients initially receive bi-therapy for 6-10 weeks. Thereafter, CYT107 is added for a cycle of four weekly injections at a defined dose level while standard bi-therapy continues for 9 weeks after CYT107 treatment discontinuation. The patients are then followed on a regular basis until reaching 48 weeks after the CYT107 treatment. The duration of study is approximatively 60 weeks with 20-25 weeks of bi-therapy.

Participants will have 1 overnight hospitalization and 15 clinic visit on a period of 60 weeks.

During the visits the following may be done:

* medical history, physical examination, blood tests
* electrocardiograms (ECG)
* chest X-Ray
* liver/spleen imaging
* urine tests

Eligibility Criteria:
Main Inclusion Criteria:

* HCV Genotype 1 infected patients
* Absence of viral response to previous treatments with pegylated interferon-alpha plus ribavirin
* Metavir ≤ F3 assessed by biopsy in the last 12 months

Main Exclusion Criteria:

* Active infection by HBV
* Infection by HIV-1 and /or HIV-2
* Apart from HCV infection, presence of active infection requiring a specific treatment or a hospitalization
* Other liver disease
* Body mass index (BMI) \> 30kg/m2
* Relapse after previous response to pegylated IFN alpha and ribavirin therapy
* Previous bi-therapy with pegylated IFN alpha and ribavirin not well tolerated (in particular treatment discontinuation)
* Any history of malignancy apart from curatively treated basal cell carcinoma or in situ cervical carcinoma
* History of clinical autoimmune disease or active auto-immune disease
* History of severe asthma, presently on chronic medications
* Significant cardiac or pulmonary disease
* Inability to give informed consent
TAP Block With Intrathecal Fentanyl vs. Intrathecal Morphine in Cesarean Delivery

This noninferiority study aims to determine whether transversus abdominis plane (TAP) block with intrathecal fentanyl could provide a noninferior analgesia compared with intrathecal morphine after cesarean delivery under spinal anesthesia.

Healthy mothers scheduled to undergo elective cesarean delivery under spinal anesthesia will be randomly allocated to receive either TAP block plus intrathecal fentanyl (Group TF) or intrathecal morphine (Group M).

Primary outcome is pain score with movement at postoperative 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Adult full-term parturients scheduled to undergo elective cesarean delivery under spinal anesthesia

Exclusion Criteria:

* Contraindication to spinal anesthesia
* Any chronic pain unrelated pregnancy
* current opioid medication use
* BMI more than 40 kg m-2
* History of drug allergy or hypersensitivity to fentanyl, morphine, ropivacaine, acetaminophen, NSAIDs, bupivacaine, ramosetron, ondansetron, nalbuphine, Naloxone, metoclopramide
* infection of abdominal wall
* Pregnancy-induced hypertension
* known cardiovascular disease
* Known fetal anomaly
* Any sign of onset of labor
Semantic Memory, Financial Capacity, and Brain Perfusion in Mild Cognitive Impairment (MCI) (CASL)

Alzheimer's disease (AD) often manifests as a memory disorder before dementia develops. Dementia is considered to be present when a person can no longer handle complex activities of daily living, such as managing finances. This study will investigate the relationship between changes in the ability to manage finances and brain perfusion, which will be measured using continuous arterial spin-labeling (an experimental MRI). Subjects will also undergo neuropsychological tests focusing on several types of memory and thought process, with special emphasis on semantic memory. An important question to be addressed is whether changes in function are better predicted by the neuropsychological tests or by the brain scan.

Alzheimer's disease (AD) often manifests as a memory disorder before dementia develops. Dementia is considered to be present when a person can no longer handle complex activities of daily living, such as managing finances. This study will investigate the relationship between changes in the ability to manage finances and brain perfusion, which will be measured using continuous arterial spin-labeling (an experimental MRI). Subjects will also undergo neuropsychological tests focusing on several types of memory and thought process, with special emphasis on semantic memory. An important question to be addressed is whether changes in function are better predicted by the neuropsychological tests or by the brain scan. Participants will undergo a single MRI scan, baseline financial capacity instrument (FCI) and cognitive evaluation, and then will be followed approximately annually to repeat the functional and cognitive assessments. Linear mixed effects models will be used to fit a model predicting financial capacity based on baseline cognitive tests. Measures from the MRI scan will be added to the model to determine whether imaging improves the predictions.

Eligibility Criteria:
Inclusion Criteria:

* Veteran or non-veteran
* Age 50-89
* With normal cognition or memory impairment (MCI or mild AD)
* English speaking
* Right handed
* Adequate vision and hearing to take part in tests
* Able and willing to undergo MRI scan
* Medically and psychiatrically stable
* No other brain disease (such as tumor, Parkinson's disease, major stroke)

Exclusion Criteria:

* Pregnancy
* Inability to tolerate MRI (due to metal in body or claustrophobia)
Acupuncture in a Multidisciplinary Approach for Vulvodynia and Chronic Pelvic Pain

Background: Vulvodynia and chronic pelvic pain (CPP) are common and challenging gynecologic pain syndromes. A multidisciplinary approach is recommended.

Study aim: To study the effectiveness of acupuncture as part of a multimodal treatment for women with vulvodynia and CPP.

Design: Randomised controlled clinical study

Study Population: Recruitment from a University outpatient clinic Study groups: Participants will be randomised (1:1)

* Acupuncture group
* Waiting list control group

Sample size: 68 patients

Study outcome

* Subjective Pain Perception (VAS)
* Health-related quality of life (questionnaires)


Eligibility Criteria:
Inclusion Criteria:

* Women with vulvodynia and/or chronic pelvic pain of at least 6 months duration
* multidisciplinary treatment for at least 3 months

Exclusion Criteria:

* Pregnancy
* Current malignancy
* Major neurologic or psychiatric morbidity
* Study participation in Lydia trial (Lasertherapy for vulvodynia)
Sensory Properties of Bowel Cleansing Solutions

Samples of 4 commercially available bowel cleansing solutions, namely PEG-electrolyte + ascorbic acid (PEG-Asc, Moviprep®, Norgine, UK), PEG-electrolyte (PEG, Fortrans® Ibsen, France), sodium picosulfate/magnesium citrate (SPS, Picoprep®, Ferring, Switzerland), and oral sodium sulfate (OSS, Izinova®, Ibsen, France) were prepared according to the manufacturer's instructions. Descriptive analysis was conducted with trained panelists (N= 14) to create a sensory profile for the solutions and generated attributes were rated on an unstructured 15-cm line scale using the Compusense at-hand® (Guelph, Canada) sensory evaluation software. Acceptability testing was carried out with untrained participants (N=80) and samples were rated on the 9-point hedonic scale. Moreover, a Just-About-Right (JAR) scale was included for the four basic tastes to determine their compatibility with optimum taste/acceptability levels in the products.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 50 years

Exclusion Criteria:

* allergies to polyethelene glycol (PEG), artificial sweeteners
Does Vitamin D Improves Sustained Virologic Response (SVR) in Genotype 2,3 Chronic Hepatitis C Patients?

Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3. Studies rarely address the issues of improving host factors. The current study examines

1. whether adding vitamin D, a potent immunomodulator, could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks)
2. whether Vitamin D levels predictes negative treatment outcome.

Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3. Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D, a potent immunomodulator, could improve viral respons.The working hypothesis is that Adding vitamin D to conventional Peg/RBV therapy for naïve, genotype 2,3 patients with chronic HCV infection significantly improves RVR, EVR, and SVR

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age,
* Chronic genotype 2,3 HCV infection, Traetment Naive
* Negative sero for HBV, HDV and HIV viral infections
* Absolute neutrophil count of \>1500 per cubic millimeter, a platelet count of \>90,000 per cubic millimeter
* Normal hemoglobin level

Exclusion Criteria:

* Decompensated liver disease (cirrhosis with CP score \>9)
* Another cause of clinically significant liver disease
* Hepato cellular carcinoma
* Psychiatric Disorder
* Chronic heart failure
* Pregnant women
* Uncontrolled diabetes with retinopathy
* Arythmia
* Active CAD
* Positive sero for HBV, HDV and HIV viral infections or other autoimmune liver disease
Investigation of DEXA-C Anterior Cervical Interbody System

FDA Cleared interbody product for the cervical spine, designed to match a patients DEXA scan for increase in fusion rate.

The DEXA-C Cervical Interbody System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1. Device system is designed for use with supplemental fixation and autograft and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone to facilitate fusion and is to be implanted via an open, anterior approach. The Dexa-C clinical study will collect data on those patients who have been treated with Dexa-C Anterior Cervical Interbody System to allow for a better understanding of outcomes associated with it.

Eligibility Criteria:
Inclusion Criteria:

1. Must already be scheduled or planned for anterior cervical discectomy and fusion using the Dexa-C Anterior Interbody System C3-7 with supplemental fixation and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone meeting on-label criteria.
2. Radicular signs and symptoms in one or both arms (i.e., pain, paresthesia or paresis in a specific nerve root distribution).
3. Diagnosis of cervical radiculopathy at one or two contiguous levels from C3-7 requiring open anterior cervical fusion and discectomy.
4. Diagnosis of degenerative disc disease by radiographic evidence of cervical disc herniation and/or osteophytes accompanying clinical symptoms.
5. At least 6 weeks prior conservative treatment (i.e. physical therapy, pain medication).

Exclusion Criteria:

1. History of cervical spine surgery less than 12 months prior to surgery.
2. Diagnosis of severe spondylosis.
3. Patients requiring posterior cervical surgery, anterior cervical corpectomy, or revision surgery.
4. Any member of a vulnerable population (ie. minors, adults who lack the ability to consent, pregnant women, etc.)
The REVEALPLAQUE Study: A pRospEctiVe, multicEnter Study to AnaLyze PLAQUE Using CCTA

This study will evaluate the level of agreement between noninvasive CCTA-based quantification and characterization of coronary atherosclerosis and invasive IVUS .

This is a prospective, multi-center study. All patients who have a stenosis in at least one major epicardial vessel confirmed by CCTA, who have undergone FFRCT analysis, and who are scheduled to undergo clinically indicated IVUS-guided invasive evaluation and/or treatment will be eligible for enrollment. Enrolling sites will have FFRCT analysis incorporated when indicated into their standard evaluation of CCTA scans. Data collected will include CCTA and FFRCT, full angiographic, and IVUS images, and if obtained, any other imaging or physiologic data including OCT, FFR, any NHPR (e.g., dPR, RFR, iFR, etc.), and pre- and post-stent implantation invasive data. All non-invasive and invasive data collected will be obtained as clinical practice consistent with standard clinical care.

Eligibility Criteria:
Inclusion criteria (all must be present):

1. Age ≥18 years
2. Clinically stable patient with known CAD
3. CCTA showing stenosis in at least one major epicardial vessel of stentable/graftable diameter, in whom clinically indicated IVUS is planned within 45 days of the CCTA and FFRct available
4. FFRct successfully processed
5. Willing to comply with all aspects of the protocol
6. Agrees to be included in the study and able to provide written informed consent.

Exclusion criteria (all must be absent):

1. 1. CCTA showing no stenosis
2. Uninterpretable CCTA by HeartFlow assessment, in which image quality prevents FFRCT from being processed.
3. Acute chest pain
4. CABG prior to CCTA acquisition
5. Prior history of PCI for 3 or more vessels
6. MI less than 30 days prior to CCTA or between CCTA and ICA.
7. Suspicion of acute coronary syndrome (acute myocardial infarction or unstable angina)
8. Known complex congenital heart disease
9. Tachycardia or significant arrhythmia
10. Subject requires an emergent procedure
11. Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure \<90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema
12. Any active, serious, life-threatening disease with a life expectancy of less than 2 months
13. Currently enrolled in another study utilizing FFRCT or in an investigational trial that involves a non-approved cardiac drug or device
14. Persons under the protection of justice, guardianship, or curatorship
Methylene Blue Treatment of COVID-19

Despite enormous progress in understanding COVID-19, there is little evidence that a solution, therapeutic or preventive, is close to being achieved. Repurposing of well known, widely available drugs represent an attractive approach to speed up availability of active treatments. Such substances as i.e. hydroxychloroquine and others, are already under investigation and in widespread off label use. For many reasons Methylene blue (MB), the oldest synthetic substance in medicine (1876 synthesized by BASF) is such a promising candidate for an active treatment against SARS-CoV-2 infected people and for COVID-19 patients.


Eligibility Criteria:
Inclusion criteria are:

* signed informed consent
* age ≥ 18 years
* microbiologically confirmed SARS-CoV-2 infection
* negative pregnancy test in women of child-bearing age

Exclusion criteria are:

* documented refusal to participate in the study
* known G-6-Phophatase deficiency
* treatment with a serotoninergic drug
Metacognitive Therapy for Health Anxiety

The study involves a comparing a new psychological treatment- Metacognitive Therapy (MCT) which has shown promising results in the treatment of health anxiety to no treatment at all- a waiting list.

Hypochondriasis or severe health anxiety is characterised by excessive, disproportionate and persistent thoughts, behaviour and emotion focused on physical symptoms and/or fear of developing a serious illness. There is often excessive worry about illness or disease in the absence of supporting medical evidence and contrary to continual medical reassurance.

The most effective psychological treatments are cognitive and behavioural therapies (CBT). However, CBT has failed to demonstrate consistent gains in the treatment of this disorder.

A newer form of psychological therapy, Metacognitive Therapy (MCT) has shown to be more effective than CBT in the treatment of anxiety disorders and depression. MCT is based on the principle that health anxiety is caused by a pattern of extended thinking, this pattern is called the Cognitive Attentional Syndrome (CAS). The CAS is made up of chains of verbal thought in the form of excessive worry about having an illness; a pattern of focusing attention on threat, such as scanning the body for signs of illness and excessive body checking; and coping strategies that have negative effects, such as internet searching for illnesses or trying to block out thoughts of illness. Rather than stopping negative thinking the CAS extends it and leads to the belief that illness is present. To help reduce these symptoms MCT teaches specific techniques that help people develop new ways of experiencing negative thoughts about illnesses, allow them to abandon worry and learn to disengage from unhelpful coping attempts.

A recent small study has provided some limited evidence that metacognitive therapy (MCT) can be applied to cases of hypochondriasis and demonstrated that the therapy was associated with improvement in symptoms.

To provide future evaluation of MCT in this client group a more definitive trial will be carried out to ascertain the effects of MCT in a larger group when compared to a control group.

If the results are positive this will provide a rationale for a larger research study, which will compare MCT with evidence based treatment such as CBT.

Eligibility Criteria:
Inclusion Criteria:

* Be over 18.
* Exceed cut off on BP and WI
* Not undergoing any other form of psychological therapy during treatment.
* If on medication must be stable six weeks prior to treatment onset.
* Willing to undergo randomisation
* Provide written consent

Exclusion Criteria:

* Be under 18
* Not exceeding cut off on BP and WI
* Undergone CBT for health anxiety over the past three months.
* Having started medication less than four weeks before assessment
* Not willing to undergo randomisation
* Not willing to provide written consent
A Study of Nivolumab in Patients With Head and Neck Cancer.

A prospective real world evidence study of Nivolumab use in France in patient with recurrent or metastatic squamous cell carcinoma of the Head and Neck progressing on or after a platinum based therapy


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Squamous Cell Carcinoma Head and Neck (SCCHN) patients progressing on or after platinum-based therapy.
* Diagnosis of SCCHN has been confirmed by histology or cytology (either at initial diagnosis or any time later during the course of the disease)
* Treatment decision to initiate a treatment with nivolumab for the first time for the treatment of SCCHN (according to the label approved in France) has already been taken

Exclusion Criteria:

* Patients previously treated with Nivolumab, Ipilimumab, or any other antibody or drug specifically targeting T-Cell Co stimulation or immune Checkpoint pathway.
* Patients currently included in an interventional clinical trial for their SCCHN.

Other protocol defined inclusion/exclusion criteria could apply
Acupuncture for the Treatment of Post-Traumatic Stress Disorder (PTSD)

The purpose of this study is to evaluate acupuncture as a treatment for Post-Traumatic Stress Disorder (PTSD) and to correlate the diagnosis of PTSD with Traditional Chinese Medicine (TCM) diagnostic patterns.

This study will evaluate: 1) the TCM diagnostic differentiation patterns of people who have PTSD as defined by the Diagnostic and Statistical Manual, 4th edition; 2) if an acupuncture treatment approach is acceptable to people with PTSD; and 3) if an acupuncture treatment approach is associated with a reduction in PTSD symptoms that is comparable to that of standard treatments. Because symptoms of depression, insomnia, and pain are often associated with PTSD, we will also evaluate the potential benefit of an acupuncture approach to depression, insomnia, and pain symptoms in people with PTSD.

Patients in this study will be randomized to one of three groups. Group A will receive acupuncture therapy. Group B will receive standard Cognitive Behavior Therapy. Group C is a control group and will receive no treatment. Patients in Groups A and B will undergo a total of 24 hours of therapy over the 3 month study course. All patients will have five nontherapeutic study visits; these visits will address diagnosis and assessment. Study visits will include assessments of PTSD symptoms, sleep symptoms, and level of impairment.

Eligibility Criteria:
Inclusion Criteria

* DSM-IV diagnosis of PTSD
* Stage I PTSD symptoms
* PTSD Symptom Scale-Self Report (PSS-SR) score \> 16
* Meets PSS-SR diagnostic criteria

Exclusion Criteria

* Stage I substance abuse and/or dependence in the past 6 months
* Psychotic disorder
* Inability to commit to treatment or wait-list conditions
* Current treatment specifically for PTSD
* Certain medical conditions, including thyroid disease, class IV heart failure, active cancer treatment, and uncontrolled diabetes
* Pregnant
* Use of benzodiazepines, narcotics, opiates, narcotic antagonists, sleep medication, muscle relaxants, analgesics, or sedatives.
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus

The purpose of this study will be to evaluate efficacy and safety of Ruxolitinib cream in participants With Cutaneous Lichen Planus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 16 weeks followed by an open label period (OLE) period of 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of LP with predominant cutaneous involvement.
* IGA score of 3 or 4 at screening and baseline.
* Baseline LP-related Itch NRS score ≥ 4.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Concurrent conditions and history of other diseases:

  1. Variants of LP deemed by the investigators to be inappropriate for topical treatment, including but not limited to predominant mucosal (such as oral or vaginal) LP.
  2. Active ongoing inflammatory diseases of the skin other than LP that might confound the evaluation of LP lesions or compromise participant safety.
  3. Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of LP lesions or compromise participant safety.
  4. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome).
  5. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.
  6. Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox, clinically infected AD, or impetigo) within 1 week before baseline.
* Laboratory values outside of the protocol-defined criteria.
* Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
* Other exclusive criteria may apply.