cyrilzakka/clinical-trials huggingface dataset:
Comparison of Indigo Naturalis Oil Extract and Calcipotriol Solution in Treating Psoriasis

The purpose of this study is to compare the efficacy and safety of indigo naturalis oil extract and calcipotriol solution in the treatment of psoriatic nails, to show that indigo naturalis oil extract may be a good choice for treating nail psoriasis, and potentially an effective alternative for those who do not respond well to traditional therapy.

In the literature, the efficacy of traditional Chinese medicine in treating nail psoriasis is rarely reported. Recently, the investigators developed a new product, indigo naturalis oil extract, which worked well in nail disease. In our randomized, observer-blind, vehicle-controlled trial showed that indigo naturalis oil extract is effective and safe in treating nail psoriasis. This study aims to compare the efficacy and safety of indigo naturalis oil extract with calcipotriol solution in patients with nail psoriasis using controlled, bilateral comparison

The investigators will enroll 33 patients with nail psoriasis from the ambulatory department of Chang Gung Memorial Hospital. Indigo naturalis oil extract will be consistently applied on either the left or right affected nail folds, while calcipotriol will be applied on the opposite side, both twice daily for 24 weeks, allowing intra-patient comparison. The nails will be assessed by two dermatologists before treatment and at week 2, 4, 8, 12, 16, 20, 24.

Eligibility Criteria:
Inclusion Criteria:

1. Nail psoriasis of the matrix and/or of the nail bed in at least one fingernail.
2. Good general health.
3. Agreement to avoid pregnancy for the study duration

Exclusion Criteria:

1. Concomitant topical treatment (corticosteroids), phototherapy, or any systemic treatment (retinoids, cyclosporine, methotrexate, systemic corticosteroids and biological agents) that could affect nail psoriasis.
2. Patients with severe hepatic or renal disorders.
3. Lactating, pregnant or planning pregnancy
4. Unwillingness to comply with study protocol.
5. A history of sensitivity to indigo naturalis. -
Study of the Safety and Tolerability of AXA1665 in Subjects With Mild and Moderate Hepatic Insufficiency

This is a randomized, single blind study to determine whether AXA1665, a composition of naturally occuring amino acids, is well tolerated in subjects with mild and moderate hepatic insufficiency. Study will also examine how the food product may influence the biology in muscle which will be assessed using magnetic resonance imaging (MRI) and other functional assessments such as strength, balance and cognition as part of a comprehensive physical/neurological exam. Changes in blood biomarkers of inflammation will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Willing to participate in the study and provide written informed consent
* Male and female adults aged \> 18 years
* Child-Pugh score ≤9 (i.e. Child-Pugh class A or B)
* Liver Frailty Index (LFI) of ≥3.6
* Willing and able to engage in 30 minutes of walking/physical activity at least 3 days per week

Exclusion Criteria:

* Hospitalization for any complication of cirrhosis or taking new medications intended to treat hepatic encephalopathy within 2 months prior to Screening or any hospitalization for any cause/reason within 30 days prior to Screening
* Prior history or presence of a transjugular intrahepatic portal systemic shunt (TIPS)
* Current or history of significant alcohol consumption
* Other poorly controlled medical condition \[e.g., renal disease with an estimated glomerular filtration rate (GFR) \<60 mL/min/1.73m2)
* Known sensitivity and/or history of clinically significant food intolerance/allergies to proteins (including whey, soy, casein, amino acids, etc.)
* Any extreme or unbalanced diet such as Ketogenic, Atkins, Paleo, Vegan, etc.
* Unable or unwilling to adhere to contraception requirements
* Any contraindications to a MRI scan
* Any other condition that, in the opinion of the Investigator, renders the subject at risk for compliance, compromises the well-being of the subject, or hinders study completion
Endoscopic Nebulizing Device for Surgical Haemostatic-sealant Glubran® 2 Usability Trial in EMR and ESD

The aim of this single-center study is to evaluate the feasibility of the technique, usability and safety of the device ENDONEB.

Single center, prospective, medical device usability and feasibility study. The study will be performed in Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome.

According to the recomandations of the Italian Ministry of Health (28) regarding the sample size of pilot and feasibility studies, 15 applications underwent to mucosal or submucosal resection procedures will be evaluated. The recruitment period will be 36 weeks (9 months). The evaluation ends when ENDONEB has been used in the fifteenth subject or at one third of applications if the investigators will be able to give their evaluation of the feasibility of the ENDONEB technique, usability and safety. The ENDONEB medical device belongs to the family of "Nebulizers" class IIa accessory devices, used to apply Glubran®2 in nebulized form in laparotomic, laparoscopic and thoracoscopic procedures. The ENDONEB medical device allows to apply the Glubran®2 in nebulized form in digestive endoscopy interventions and can be used both with gastroscopes and colonoscopes with an operating channel not less than 2.6 mm. It is marketed in sterile presentation; the components are latex free and is for single use only.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of superficial neoplastic lesion to be resected by a gastrointestinal endoscopic resection (EMR or ESD)
* Older than 18 years of age at time of consent;
* Operable per institution's standards;
* Signed and dated informed consent form

Exclusion Criteria:

* Any clinical conditions precluding the feasibility of gastrointestinal endoscopic resection (ENDONEB could be contraindicated in patients who are suspected of having a gastrointestinal perforation, or are at high risk of gastrointestinal perforation during endoscopic treatment);
* Pregnant during period of study participation;
* Allergy history to cyanoacrylate.
User Satisfaction Survey - Personality Disorder Service

Can we improve our community partners satisfaction with a change in how psychiatric consultations are delivered to their clients by our psychiatrist? This survey of users of the service will compare the level of satisfaction before(retrospectively) to after the way the service is provided is changed.

As part of the personality disorder services continuing quality improvement enterprise we sought to review the impact of restructuring on the satisfaction of service community partners with our changed consultation service.

The consultation service was changed as the result of administrative review,part of a larger institution wide process. To review how this change was perceived by agency and individual care providers those who had received consult reports from the last fifty consultations were surveyed about their satisfaction and compared prospectively to the satisfaction of the agencies and individual care providers of clients receiving the next fifty consultations delivered in the new format.

The administrative review had indicated that the consultation reports were unnecessarily comprehensive and in the process time consuming and thereby interfered with timely access to appointments and involved excessive turn around time in the generation of reports. A new streamlined approach using a fill in the blanks type form and brief cover letter and the use of a follow up phone call to the main care giver the same day was devised to address these concerns.

Satisfaction in regards to advice received, length of the report, waiting times for the appointment and for the delivery of the report,legibility and overall satisfaction were surveyed. The satisfaction with telephone feed back was also surveyed.

Eligibility Criteria:
Inclusion Criteria:

* clients referred to the Personality disorder service

Exclusion Criteria:

* self referred clients
Comparison Between the Neuromuscular Blockade Onset Monitoring and the Expectation of a Fixed Delay After Curarization on the Quality of Laryngoscopy During Intubation in Elective Surgery (MONITURARE)

During anesthetic induction, the relevance of neuromuscular blockade (NMB) onset monitoring cannot be asserted and its superiority over waiting for a fixed delay (corresponding to pharmacokinetic knowledge of the neuromuscular blocking agent used) has not been proven. However, many studies have shown a large inter-individual variability on the delay of the NMB onset. The main objective of othe investigator's study is to compare the quality of laryngoscopy during intubation between the NMB onset monitoring and the expectation of a fixed delay after curarization

French guidelines on curarization, updated in 2018, do not recommend the NMB onset monitoring due to a lack of data in the literature. Thus, the interest of monitoring cannot be asserted and its superiority over waiting for a fixed delay has not been proven.

Due to a large inter-individual variability on the delay of the NMB onset after administration of atracurium, the relevance of monitoring NMB during an anesthetic induction should be assessed to improve the quality of laryngoscopy.

In case of monitoring, the experts recommend monitoring the NMB onset at the corrugator supercilli because it reflects neuromuscular blockade at the laryngeal adductor muscles.

During the pre-anaesthetic visit, patients will be enrolled after inform consent.

Patients will be randomized in two groups, control group (waiting for a 3-minute delay after injection of atracurium) or monitoring group (waiting for the TOF ratio at 0 at the corrugator supercilli).

Anesthetic induction will be performed with sufentanil, propofol and atracurium. After laryngoscopy, the primary outcome will be evaluated using Copenhagen score.

Patients will be followed up until they leave the recovery room..

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years), both sexes
* Any elective surgery requiring injection of atracurium
* Free patient, without guardianship or subordination
* Patients with a social security coverage
* Informed and signed consent after clear and fair information

Exclusion Criteria:

* Rapid sequence induction
* Predictable difficult intubation
* Use of a neuromuscular blockade agent other than atracurium
* Known contraindication to a neuromuscular blockade agent
Data Acquisition Study in Inadequately Balanced Patients With Type 2 Diabetes Mellitus

The aim of this study is to collect continuous glucose monitoring (CGM) data, coupled with physical activity and everyday day life data. The purpose of this data collection is to help diabetologists to make recommendations to optimize type 2 diabetic patient management.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patient (T2D) with HbA1c ≥ 8% in the month prior to inclusion
* Patient is treated with oral anti-diabetics and / or analogous combined with basal insulin therapy (1 injection of slow-acting insulin in the evening)
* Age ≥ 35 years
* Diabetes diagnosis done over 1 year ago
* Patient accepting for 2 periods of 14 days spaced at most 3 days to wear a Freestyle glucose meter, a bracelet for measuring physical activity and to log daily life events in a dedicated smartphone application
* Patient is able to use a smartphone
* Patient is affiliated to the French health insurance system

Exclusion Criteria:

* Patient has Type 1 diabetes, diabetes secondary to pancreatic pathology, endocrinopathy or iatrogenic diabetes
* Patient is treated with a rapid-acting insulin
* Patient has had a severe hypoglycaemia in the year preceding inclusion
* Patent has a severe renal insufficiency (defined by a Glomerular Filtration Rate below 30 ml/min)
* Patient has had a myocardial infarction or other life-threatening medical condition in the last 6 months
* Patient has cognitive disorders or evolutionary psychiatric pathology
* Pregnant woman or woman likely to be pregnant, breastfeeding woman
* Patient plans to travel outside europe during the study
* Patient is participating to another clinical study
A Phase 1 Study To Evaluate The Safety And Tolerability Of PF-06252616 In Healthy Subjects

The purpose of this study is to determine if the study drug, PF-06252616 is safe and well tolerated when given to adult healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Single Dose Cohorts-Healthy male and/or female non-child bearing subjects between the ages of 18 and 55 years, inclusive.
* Repeat Dose Cohort-Healthy male and/or female non-child bearing subjects between the ages of 18 and less than 65 years, inclusive.

Exclusion Criteria:

* Presence or history of muscle disease (eg, polymyositis or rhabdomyolysis).
* Weight loss or gain of \>5% within 30 days of Screening, as reported by subject.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic, metabolic urologic, dermatologic, renal, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) and any other major disease.
Mastiha Treatment for Obese With NAFLD Diagnosis

NAFLD/NASH is one of the most common complications of obesity and diabetes mellitus in Western populations affecting approximately 50% of diabetics and 76% of obese patients. Due to the lack of specialized treatment, many new efforts focus on exploring alternative, non-pharmacologic means for managing the disease, including bioactive substances in fruits, vegetables and plants or their products. Mastiha, a natural product of Greece, consists of a great variety of bioactive phytochemical compounds and demonstrates antioxidant, antiinflammatory, antimicrobial and lipid lowering properties. Taking into account the contribution of oxidative stress and inflammation to NAFLD/NASH pathogenesis, the hypothesis that Mastiha could improve disease aspects is investigated. Thus, design of a multicenter (4 centers across Europe), randomized, double-blind, placebo controlled (parallel arm) clinical trial to assess the effect of Mastiha on clinical course of NAFLD/NASH patients has been conducted. The effectiveness of the proposed intervention will be evaluated via clinical and laboratory markers. MAST4HEALTH aims also at exploring gene-diet interactions and at correlating genetic and epigenetic markers with metabolomic and intestinal microbiota profiles pre- and post- intervention. To this end, patients with confirmed NAFLD/NASH will be allocated to either verum or placebo group. Duration of the intervention will be 6 months and the dosage applied will be 2.1 g daily. NAFLD/NASH diagnosis will be confirmed by MS scanning and the sensitive LiverMultiScan technique. Anthropometric, demographic data, body composition, dietary habits, physical activity, family history and smoking status will be assessed pre- and post- intervention. Biochemical profile, oxidative stress and inflammation, as well as epigenetic and metabolomic profiles will be assessed in blood samples, while the metagenome profile will be examined in stools. Both groups will receive counselling to allow for body weight regulation up to 5%. Compliance will be assessed monthly and side effects will be reported.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed NAFLD/NASH
* 18 years \< Age \< 67 years
* BMI \> 30 kg/ m2

Exclusion Criteria:

* Hepatotoxic Medication, Concomitant Liver Disease
* Decompensated Diabetes Mellitus
* Dysthyroidism, hypopituitarism, Cushing syndrome / disease
* Alcohol abuse or drug addiction
* Clinically or biochemically recognized systemic diseases
* Pregnancy test, lactation
* Vegan or lacto- and ovo-lacto- vegetarianism
* Psychiatric or mental disorder
* Recent loss in body weight or current diet
* Any use of antioxidant-phytochemical rich supplement, anti-, pre- or pro-biotics within 3 months pre-intervention
* Changes in drug treatment for e.g. hypertension, diabetes mellitus, 3 months prior or during the 6month intervention
* Antibiotic treatment during and 2 months prior to screening
Study of Cetuximab to Treat Gastric Cancer

The purpose of this study is to evaluate the efficacy and safety of cetuximab combined with FOLFIRI in patients with advanced gastric cancer who failed first-line chemotherapy

Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, there is no standard regimen for patients with A/MGC as second line treatment. Based on the promising results of cetuximab combined with FOLFIRI in metastatic colorectal cancer, we design this clinical trial to evaluate the efficacy and safety of cetuximab combined with FOLFIRI for A/MGC patients as a second line treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
* ECOG performance scale ≤ 1
* At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
* Adequate hepatic, renal, heart, and hematologic functions (platelets\>80 × 109/L, neutrophil\>2.0 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN)

Exclusion Criteria:

* Pregnant or lactating women
* Concurrent cancer
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Neuropathy, brain, or leptomeningeal involvement
* Uncontrolled significant comorbid conditions and previous radiotherapy
Predictive Tools in Head and Neck Cancer Patients Undergoing Radiotherapy

The ITHACA study aims to improve the treatment of head and neck cancer by developing a predictive tool that helps doctors personalize care for each patient. This tool uses information such as medical history, imaging, and radiotherapy data to predict the risk of cancer recurrence, overall survival, and the likelihood of side effects.

Patients with head and neck cancer face significant challenges, including managing the side effects of treatments like radiotherapy. By tailoring treatment schedules and doses, and using advanced imaging techniques, we hope to reduce complications and improve survival outcomes. The study is designed to help doctors choose the best treatment for each patient, while minimizing the side effects that impact important functions like swallowing and breathing.

Patients participating in the study will have their medical data collected, including:

Tumor characteristics (size, location, stage). Treatment details (radiotherapy and chemotherapy). Imaging information using tools like PET-CT and MRI to track the response to treatment and detect any signs of cancer recurrence.

Side effects and overall health data. This information will be used to develop and test a new model that predicts outcomes for each patient based on their unique data.

The study includes adults (18 years and older) diagnosed with head and neck cancer, who are undergoing or have completed radiotherapy. Patients will be followed over time to monitor their response to treatment and any side effects.


Eligibility Criteria:
Inclusion Criteria

Participants must meet all of the following criteria:

* Diagnosis: Confirmed head and neck cancer, including cancers of the oropharynx, larynx, hypopharynx, nasopharynx, salivary gland, unknown head and neck primary or oral cavity.
* Age: 18 years or older.
* Treatment: Undergoing or scheduled to undergo radiotherapy or chemoradiotherapy as part of their treatment

Exclusion Criteria

Participants will be excluded if they meet any of the following criteria:

* Pregnancy: Pregnant or breastfeeding women.
* Non-Compliance: Patients unwilling or unable to comply with study procedures and follow-ups.
Analysis of Markers in the Blood Correlated With Neuropathic Pain

The purpose of this study is to analyze associations between symptoms and specific markers in the blood in patients suffering from neuropathic pain linked to diseases of different origin. Such markers could be utilized in the future for precise diagnosis of neuropathic pain and might lead to targeted pain treatment.

On average, 3-8% of the German population suffers from neuropathic pain, which can occur after damage of somatosensory nerves in the peripheral or central nervous system. In terms of a "personalized" medicine, only a strict separation of neuropathic and chronic pain allows an individualized therapy to reduce pain severity and to enhance patients' quality of life.

Currently, the diagnosis of neuropathic pain is based on the medical history, the subjective description of somatosensory symptoms and the application of (non-genetic) diagnostic tests. To improve diagnosis and therapy of complex disorders for individual patients, novel methods are introduced based on flow cytometric (FACS) analysis of human immune cells or analysis of the human genome (genomics). Those techniques can support the identification of characteristic features indicating ongoing individual pathophysiologic processes in the body (biomarkers).

Often diseases are based on a complex relationship between genetics, environmental factors and the manifestation of the disease. To capture this complexity via genomics, phenotypical and genotypical data of high quality and detailed information about the study population are required.

This observational study includes patients suffering from painful and non-painful neuropathies associated with HIV-infection, diabetes mellitus and breast cancer. With the targeted application of validated questionnaires (such as the Brief Pain Inventory, Pain Catastrophizing Scale, Hospital Anxiety and Depression Scale, Ten-Item Personality Inventory, 36-Item Short Form Health Survey, and the Insomnia Severity Index) and parallel usage of genomics or FACS analysis of selected biomarkers in the blood, this study will provide information about the manifestation of certain genes or immune markers which are directly correlated to the symptoms of the disease. Additional performance of neuropsychological/cognitive tests and quantitative sensory testing (QST) will enhance the phenotypic profile. Identification of potential indicators could be utilized prospectively to precisely diagnose and effectively treat neuropathic pain.

Eligibility Criteria:
Inclusion Criteria:

* HIV-associated neuropathy
* Sufficient knowledge of the German language

Exclusion Criteria:

* Co-incident severe central nervous system diseases
* Major psychiatric conditions
* Dementia
* Limited mental capacity or limited German language skills
* Intoxication with alcohol or recreational drugs within the last 48 hours of the study