cyrilzakka/clinical-trials huggingface dataset:
Ingenol Mebutate (Picato®) With Methyl Aminolevulinate Photodynamic Therapy for the Treatment of Actinic Keratosis

The objective of this study is to determine the efficacy, safety, and patient satisfaction of pretreatment with Picato® gel 4 days prior to methyl aminolevulinate photodynamic therapy (MAL PDT). Patients diagnosed with actinic keratosis who are eligible to receive topical treatment with ingenol mebutate (Picato®) and photodynamic therapy will act both as the test group and the control group. Each patient will have four distinct treatment areas of 25cm2 on the scalp, and/or scalp and face. Three of the treatment areas will receive Picato® 0.015% gel, MAL PDT, or Picato® 0.015% and MAL PDT combined. One area will serve as a control and will receive none of the treatments.

Study Objective The objective of this study is to determine the efficacy, safety and patient satisfaction of pretreatment with Picato® gel 4 days prior to methyl aminolevulinate photodynamic therapy (MAL PDT). This test area will be compared to Picato® treatment alone or MAL PDT alone treatment areas as well as a control field (no treatment).

Rationale This study focuses on the topical treatment of actinic keratosis. Patients diagnosed with actinic keratosis who are eligible to receive topical treatment with ingenol mebutate (Picato®) and photodynamic therapy will act both as the test group and the control group. Patients will be followed through appointments with the study nurse and dermatologist.

Patient treatment eligibility and regimen for prescribed medication are at Dr. Rivers (and patient's) discretion. Patients will be followed in the study for the duration of one complete treatment plus 2 months.

Study duration:

The inclusion period is 6 months, depending on the speed of patient recruitment. The study duration for each individual patient will end eight weeks after treatment completion.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 40 yrs
2. Patients eligible to receive topical treatment with ingenol mebutate gel and photodynamic therapy for treatment of actinic keratosis at the discretion of the dermatologist.
3. Fitzpatrick Skin Type I \& II.
4. Patient must give informed consent.

Exclusion Criteria:

1. Diagnosis of Basal Cell Carcinoma(BCC), Squamous Cell Carcinoma(SCC) or melanoma in the treatment area.
2. Currently experiencing adverse reactions and/or Local Skin Reactions from previous Actinic Keratosis(AK) treatment in the treatment field.
3. Females who are pregnant, nursing or planning a pregnancy during their participation in the study.
4. Female subjects of childbearing potential (including subjects using surgical sterilization, ie, bilateral tubal ligation or implanted device methods of contraception) with a positive urine pregnancy test at Day 1 prior to study treatment; a female is considered NOT to be of childbearing potential if she is post-menopausal with at least 12 consecutive months of amenorrhea, has undergone bilateral oophorectomy, or has no uterus.
Evaluation of the Single Use Flexible Optical Scope Versus Multiple Use Flexible Optical Scopes for Intubation

The study is in two parts

Part one of the study describes the use of the new single-use flexible video-scope for intubation of patients with predicted normal airways.

Part two compares the performance of the single-use flexible video-scope with that of a conventional flexible video-scope for awake intubation of patients with predicted difficult airways.

The hypothesis is that the new single-use flexible video-scope for intubation performs as well as the traditional scope.


Eligibility Criteria:
Inclusion Criteria:

1. Study part 1:

   * Patients scheduled for tracheal intubation and predicted to have a normal airway
   * ASA class I, II or III
   * \>18 years
2. Study part 2:

   * Adult patients scheduled for tracheal intubation and predicted to have a difficult airway
   * ASA class I, II or III
   * \>18 years

Exclusion Criteria:

1. Study part 1:

   * Massive bleeding from the mouth
   * Previously abandoned flexible optical intubation
2. Study part 2:

   * Massive bleeding from the mouth
   * Previously abandoned flexible optical intubation
   * Patients with audible stridor
   * Patients with dyspnea
Moving Cupping for Plaque Psoriasis: a Randomized Controlled Trial

The purpose of this study was to provide evidence support for the effectiveness and safety of moving cupping therapy for plaque psoriasis through clinical studies.

Psoriasis is a common chronic and recurrent inflammatory skin disease. The incidence of the disease is increasing year by year, seriously affecting people's quality of life. The systematic treatment of psoriasis in modern medicine is limited of wide application due to the adverse reactions of different degrees and the high economic cost.

Complementary and alternative medicine (CAM) therapies have become an increasingly visible part of dermatology. Cupping is becoming an important therapy in complementary and alternative medicine. Although, moving cupping therapy has been widely used in the treatment of plaque psoriasis and has been recognized by a large number of peers and patients, but still lacks high-quality evidence-based medical evidence. Therefore, the project team intends to provide evidence support for the effectiveness and safety of moving cupping therapy for plaque psoriasis through clinical studies.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnostic criteria for plaque psoriasis;
2. Skin lesions involve ≤10% BSA (the lesions are mainly located in the torso / limbs, palm / sole, face / scalp, vulva area is not included);
3. Aged between 18 and 65 years.
4. Consent to participate in the research study and sign the informed consent form

Exclusion Criteria:

1. Patients with pustular psoriasis, arthropathic, erythroderma psoriasis and / or drip psoriasis;
2. Plaque psoriasis patients with BSA\>10%;
3. Any clinically active skin diseases other than moderate to severe psoriasis vulgaris which might counter or influence the study aim;
4. Patients who used any of the following systemic treatments within 4 weeks before the Baseline visit e.g.: drugs for other studies, immuno-suppressive drugs, biologics;
5. Patients who used topical treatment within 2 weeks before the Baseline visit e.g. corticosteroids ultraviolet-light therapy including sunbathing;
6. Active infectious disease which was hard to control;
7. History of severe systemic disease. Or the clinical test index is one of the following: the ALT or the AST is higher than 1.5 times; Any of the main routine blood indexes (WBC, RBC, HB, PLT) is lower than the limit of normal; or other laboratory abnormalities and patients were judged not to be suitable for this study;
8. Family history of cancer-prone patients;
9. Patients with immunocompromised and can cause skin allergies and infection when moving cupping;
10. Pregnant or lactating women;
11. Patients with a history of alcohol abuse and drug abuse;
12. Have a history of serious mental illness or family history; 13 Other reasons researchers believe that patients are not suitable for this study.
Gut Microbiota is Associated With Autoimmune Thyroid Disease

Autoimmune thyroid disease (AITD), which includes Hashimoto's thyroiditis (HT) and Grave's disease (GD), are the most common organ-specific autoimmune diseases and affect more women than men, with a female-to-male ratio from 5 to 10. Many studies have indicated that alterations in the gut microbiota are important environmental factors in the development of inflammatory and autoimmune diseases. Investigators systematically performed a comparative analysis of the gut microbiota in AITD patients and healthy controls.

Autoimmune thyroid disease (AITD), which includes Hashimoto's thyroiditis (HT) and Grave's disease (GD), are the most common organ-specific autoimmune diseases and affect more women than men, with a female-to-male ratio from 5 to 10. These two diseases are clinically diverse because in HT, T cells aid in the destruction of the thyroid epithelial cells (thyrocytes) and thyroid epithelial structure and eventual fibrous replacement of parenchymal tissue leading to hypothyroidism, whereas GD is primarily a humoral disease where auto-antibodies are generated against the thyroid stimulating hormone receptor (TSHR) leading to hyperthyroidism (2,163-165). However, these diseases still share several immunological features，and the disease may progress from one state to another as the autoimmune process evolves. Many studies have indicated that alterations in the gut microbiota are important environmental factors in the development of inflammatory and autoimmune diseases. Investigators systematically performed a comparative analysis of the gut microbiota in AITD patients and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 65 years
* Male or female gender
* Euthyroidism (normal FT3, FT4, and TSH plasma levels without hormonal therapy)

Exclusion Criteria:

* Pregnancy
* Lactation
* Cigarette smoking
* Alcohol addiction
* Hypertension
* Diabetes mellitus
* Lipid dysregulation
* BMI \> 27
* Recent (\< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine
* Known history of disease with an autoimmune component such as MS, rheumatoid arthritis, IBS, and IBD
* History of malignancy or any gastrointestinal tract surgery (e.g., gastrectomy, bariatric surgery, colectomy, ileectomy, cholecystectomy or appendectomy).
Expanded Access to Provide Copanlisib for Patients With Cancer Who Are Experiencing a Positive Response, as Determined by Their Doctors

The purpose of this Expanded Access Program (EAP) is to allow patients to continue receiving treatment with copanlisib if they are currently having, in the opinion of their healthcare provider, an objective favorable response when taking copanlisib. Patients considering this access program should have no other therapeutic option, have not developed a disease and/or medical condition (including pregnancy), and/or have a toxicity that would conflict with continuing to receive copanlisib.


Eligibility Criteria:
Inclusion Criteria:

* Patient has provided written informed consent.
* Patient meets one of the following criteria:

  * Already enrolled and on treatment with copanlisib in Bayer-sponsored Study 17067 (CHRONOS-3), OR
  * Already enrolled and on treatment with copanlisib in an investigator-initiated research (IIR)/institution-sponsored collaborative study (ISCS), OR
  * Currently on copanlisib treatment prescribed by a healthcare provider.
* Patient is deriving an objective favorable response from copanlisib in the opinion of their healthcare provider.
* Patient has no suitable alternative treatments available.
* Women of childbearing potential and men must agree to use effective contraception when sexually active due to potential embryo-fetal toxicity for 1 month after the last dose.

Exclusion Criteria:

* Patients who may have developed a disease/condition/toxicity that would conflict with continuing to receive copanlisib treatment.
* Patients on treatment with rituximab (R) either alone or in combination with chemotherapy, including an alkylating agent (e.g. bendamustine \[R-B\] or cyclophosphamide, hydroxydoxorubicin, vincristine, prednisone \[R-CHOP\]) for relapsed indolent non-Hodgkin's lymphoma (iNHL).
Effect of Deep Brain Stimulation (DBS) on Sleep Architecture in Patients With Movement Disorders

The purpose of this prospective, participant-blinded trial is to determine the changes in sleep architecture in a cohort of subjects who have undergone deep brain stimulation (DBS) surgery for treatment of movement disorders such as moderate to advanced Parkinson's disease (PD), tremor, or dystonia. Our preliminary observational data suggest that unilateral subthalamic nucleus (STN) DBS improves subjective sleep quality in PD patients 6 months after the procedure. The cause of this improvement in sleep quality is unknown, and this study proposes the use of polysomnography (PSG) to test whether the improvement in sleep is independent of improvement in night-time mobility associated with DBS treatment of the motor symptoms of PD, tremor, or dystonia.


Eligibility Criteria:
Inclusion Criteria:

* Prior DBS surgery for treatment of movement disorders such as PD, tremor, or dystonia.
* Stable DBS stimulator settings and medication regimen for at least 6 weeks prior to the sleep studies.
* Sleep dysfunction as measured by the Pittsburgh Sleep Quality Index (PSQI) (score \>5) at the subject's baseline pre-surgical evaluation.

Exclusion Criteria:

* Known narcolepsy
* Other previous surgical treatment of Parkinson's disease, tremor, or dystonia (with the exception of DBS) including pallidotomy, thalamotomy, or gene therapy procedures.
* Untreated obstructive sleep apnea. If obstructive sleep apnea is discovered during the first sleep study, the subject will be removed from the study. After they have been treated for at least 6 weeks with CPAP, they can re-start the study.
Magnetic Resonance Imaging (MRI) in Motion

This study is a research initiative established to explore the use of magnetic resonance imaging (MRI) as a tool for detecting organ motion as it pertains to planning radiation therapy.

The goal with radiation therapy is to treat the defined tumor and spare the surrounding normal tissue from receiving dose above specified tolerance doses. There is evidence of improved local control and survival with higher doses of radiation, however, at the same time there is the need to spare normal tissues from higher doses of radiation. Technologies that allow the delivery of an increased radiation dose to the tumor while sparing normal tissue have the potential of improving the therapeutic ratio. However, the development of these technologies has been hampered by organ respiratory motion particularly in the case of the lungs and liver. Inadequate radiation coverage of a tumor secondary to organ motion can lead to delivering a lower dose to a portion of the tumor. Making the field of radiation larger to account for organ motion results in unnecessary radiation dose to surrounding healthy tissues. It is therefore desirable to document the extent of motion of the organ in question prior to carrying out the radiation treatment planning. The organ motion impacts directly on the radiation dose distribution in the treatment volume.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 21
* Patients with primary or metastatic tumors in the lungs, liver, or pancreas
* Patients undergoing a planning CT scan in the Department of Radiation Oncology with tumor motion assessment - planning 4D-CT ordered by the treating Radiation Oncologist
* Signed, specific informed consent prior to study entry

Exclusion Criteria:

* Any condition for which a MRI procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non- MRI compatible surgical clips, shrapnel, etc
* Pregnant or breast-feeding women
* Subjects who have difficulty lying flat on their back for extended periods of time
Cardiovascular Risk in Digital Osteoarthritis

The goal of this cross-sectional case control study is to investigate the cardiovascular risk in digital osteoarthritis. This study aims to compare the cardiovascular risk between group of patients with digital osteoarthritis and control group of patients with non-osteoarthritis disease paired by measurement of carotid intima-media thickness. All participants will undergo an ultrasound scan to measure carotid intima media thickness, a clinical assessment with the rheumatologist and a cardiovascular risk assessment.


Eligibility Criteria:
Inclusion Criteria:

For all subjects:

* Adult male or female subject
* Able to give informed consent to participate in research
* Affiliated with a Social Security plan

For the digital osteoarthritis group:

* Consultant in Rheumatology at Clermont-Ferrand University Hospital
* Affected by digital osteoarthritis meeting ACR diagnostic criteria with radiographic signs of osteoarthritis validated by a radiologist.

For the control group :

* Rheumatology consultant at the Clermont-Ferrand University Hospital or hospitalized in this department for a non-arthritic, non-rheumatic pathology.
* Patients with spinal disc pathology (lumbago, radiculalgia due to disco-radicular conflict) or non-severe osteoporosis, i.e. with a densitometric T score between -2.5 and -3 DS.

Exclusion Criteria:

For all topics :

* Refusal to participate
* Pregnant women, nursing mothers
* Subjects under guardianship or curatorship, deprived of liberty, or under court protection

For the digital osteoarthritis group:

- Existence of diagnostic arguments for another inflammatory rheumatism (rheumatoid arthritis, spondylarthritis, psoriatic arthritis, lupus, gout, chondrocalcinosis...) or another arthrosic localization (gonarthrosis, coxarthrosis, discarthrosis) symptomatic at the time of inclusion or affecting daily activities.

For the control group :

* Existence of chronic inflammatory rheumatism (rheumatoid arthritis, spondylitis, psoriatic arthritis, lupus, gout, chondrocalcinosis...)
* Existence of digital osteoarthritis
* Existence of another painful arthritic site (knee, hip, rachi) Existence of finger pain, whatever the etiology.
COVID-19: Salvage TOcilizumab as a Rescue Measure

Evaluating the efficacy of Tocilizumab in hospitalized patients in the inflammatory phase of COVID-19. Randomization 2:1 (TCZ:standard of care).


Eligibility Criteria:
Inclusion Criteria:

* written informed consaent obtained
* hospitalized with COVID-19 disease
* Age \>/= 18 years
* SARS CoV-2 NhO posit
* Sp=2 \</93% on ambient air or respiratory rate \>30 /min
* Any 2 of the 4: P-IL-6 \> 2 x ULN / P-ferritin \> 2 x ULN / P-FIDD \>1.5 mg/l / P- CRP \>40 mg/l without obvious presence of bacterial infection (normal values: P -IL-6 \<5.9 ng/l; P-ferritin, men 30-400 mikrog/l, women 13-150 mikrog/l ; P-FIDD (Fibrin degradation products, D-dimer) \<0.5 mg/l; P-CRP \<10 mg/l)

Exclusion Criteria:

* Known severe allergic reactions to monoclonal antibodies
* Active confirmed tuberculosis with ongoing treatment or obvious tuberculosis or obvious other bacterial, fungal or viral infection (besides COVID-19)
* In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
* Long-term oral anti-rejection or immunomodulatory drugs (including corticosteroids equivalent to methylprednison 15mg/day)
* Pregnant or lactating women. If needed, exclusion of pregnancy should be performed by laboratory test (U-hCG-O).
* Participating in other drug clinical trials
* Absolute neutrophil count \< 1 x10E9/l
* Platelet count \<50 x10E9/l
* ALAT \>10x ULN
Nicotine Metabolizers and [11C]-(+)-PHNO

The purpose of this study is to investigate the effects of nicotine metabolism on occupancy of \[11C\]-(+)-PHNO to DA 2/3 receptors in different brain areas during periods of abstinence and smoking during an abstinence. This will be a Positron Emission Tomography (PET) study and the radiotracer \[11C\]-(+)-PHNO (11C\]-( + )-4-propyl- 3,4,4a,5,6,10b-hexahydro-2H-naphtho\[1,2-b\]\[1,4\]oxazin-9-ol) will be used.

The participants will undergo a PET scan after approximately 48 hours abstinence (to ensure total elimination of nicotine in both FMs and SMs) and then approximately \>5 hours later may have a second PET scan after smoking their preferred cigarette (approximately 1 hour before). It is possible that these two scans may also occur on separate days. All subjects will provide a urine sample for (1) drug toxicology, (2) pregnancy test (in females) and (3) Total Nicotine Equivalents (TNE: a measure of total consumption unaltered by rate of nicotine metabolism). There will one blood draw taken before and one after each PET scan (about 20mls in total) to measure nicotine and COT levels (to assess abstinence) as well as kinetics of nicotine delivery. Participants will be given questionnaires prior to, or during, and/or after one or both of the PET scans to determine differences between abstinence and smoking on subjective measures..

Eligibility Criteria:
Inclusion Criteria:

* Males and females of any ethnic origin 18 years of age or older.
* No previous use of medication for smoking cessation in previous month-
* Non-treatment seeker
* Either SMs or FMs by NMR

Exclusion Criteria:

* DSM-IV diagnosis of other drug dependences
* Any medical condition requiring immediate investigation or treatment
* Pregnancy tested by urine or lactation by self-report
* Current diagnosis of any Axis I psychiatric disorder
* Regular use of any therapeutic or recreational psychoactive drug use that may interfere with PET scanning
* Exposure to radiation in the last 12 months exceding permissible limit for participants participating in research
* Current use of medication that may interfere with \[11C\]-(+)-PHNO
* Metal implants or paramagnetic objects within the body which may interfere with the MRI
* Claustrophobia or a history of panic attacks
* Having any clinical condition, drug sensitivity, or prior therapy which, in the investigator's opinion, makes the participant unsuitable for the study
* Current use of antidepressants that may inhibit CYP2A6 or impact response to nicotine
Identification of Serum Markers For Tumor Hypoxia in Non-Small Cell Lung Cancers

The purpose of the study is to identify a surrogate serum marker for tumor hypoxia in patients with lung cancers.


Eligibility Criteria:
Inclusion Criteria:- Newly diagnosed patients with lung cancer who are undergoing surgical resection of their tumors Exclusion Criteria:- Patients without non-small cell lung cancer
Effects of the in Situ Simulation to Competencies in Cardiopulmonary Resuscitation in the Nursing Team.

Introduction: In situ simulation is a methodology that meets the concept of permanent education, since it allows learning from the context of practice and in the work environment itself.

Objective: to compare the development of skills (knowledge and skills) for CPR between groups submitted to different in situ simulation periodicities, and to identify the level of confidence to participate in a CPR.

Method: A randomized controlled, non-blind study comparing 3 periodicities of educational intervention performed by in situ simulation. This study will include nursing professionals from the nephrology department of a university hospital. The sample will be composed of 24 randomized participants in the groups, using opaque envelopes for each periodicity of training and professional category, being subdivided into 3 groups of periodicities with intervals of 2, 4 and 8 months. The instruments will evaluate the knowledge and skills in cardiopulmonary resuscitation and the perception of preparation for performing the maneuvers.

The objective is to compare the development of skills (knowledge and skills) for CPR between groups submitted to different in situ simulation periodicities, and to identify the level of confidence to attend a CPR.

Eligibility Criteria:
Inclusion Criteria:

* They must be nurses and nursing technicians.

Exclusion Criteria:

* not complete the evaluations
* be under 18 years old