cyrilzakka/clinical-trials huggingface dataset:
Evaluate Performance and Safety of Hyalo4 Skin in Acute and Chronic Wounds

Evaluate the performance and safety of the use of Hyalo4 Skin Gel in terms of wound management

Ths clinical investigation study is to evaluate the performance and safety of Hyalo4 Skin Gel in the management of acute or chronic wounds of different etiology, according to the indication for use, the prescriptions of the clinicians and the standard procedures of the sites.

A maximum of 7 Visits will be performed, with the first 4 visits performed over a 4-weeks period for each patient and the last visit after 8 weeks from the first visit.

The schedule treatment will consist of daily medication changes, according to the instruction for use and the clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent.
2. Male or female ≥18 years.
3. Patients selected to be treated with Hyalo4 Skin Gel.
4. Patients with wound of the following etiology: first and second degree burns; surgical wounds; vascular ulcers; metabolic ulcers; pressure ulcers.
5. Patients followed on an outpatient or home basis.
6. Wound area ≥ 10 cm2 and ≤ 100 cm2

Exclusion Criteria:

1. Patients \< 18 years.
2. Patients with acute or chronic infected lesions.
3. Hospitalized patients.
4. Women who are pregnant or breastfeeding or women who could become pregnant and are not using effective contraception.
5. Patients with acute or chronic lesions at high risk of infection, presenting at least one of the following criteria:

   * Stalled wound, without any clinical sign of healing progression
   * Immune system disorders
   * Protein-energy malnutrition
   * Alcohol, smoking and drug abuse (50ml of spirit, 0,5L of wine and 10 cigarettes/day)
   * Conditions associated with hypoxia and/or poor tissue perfusion
   * Corticosteroid, cytotoxic or immunosuppressive therapy.
6. Subjects unable to understand informed consent or having a high probability of non-compliance with the study procedures and or non-completion of the study according to investigator's judgement
Natural History of NFAI: 10 Year Follow-up Results

The data on long term natural history of benign nonfunctioning adrenal tumors (NFATs) are lacking. The aim is to identify clinical characteristics associated with tumor growth and progression to mild autonomous cortisol excess over time.

After being informed about the study, all patients with NFAT given written informed consent will underwent a control visit approximatly 10 years after initial visit at the outpateint clinic at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia. The included patients will be divided in three groups regarding the BMI as follows: BMI \< 25 kg/m2, 25-30 kg/m2 and \> 30 kg/m2. The investigators will assess clinical, and laboratory parameters and CT findings at the follow up visit and compere them to baseline characteristics.

Eligibility Criteria:
Inclusion Criteria:

- Patients hospitalized because of NFAI between 2005-2012 at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia.

Exclusion Criteria:

* age below 18 years
* relatives reported that patient died in the time since hospitalization
* patient did not want a follow up
* patient did not attend follow up appointment
* patient underwent adrenalectomy
* misdiagnosis / missing main information in hospitalization record
The Immediate Effect of Electrical Stimulation Transcranial Direct Current (tDCS) Associated With the Use of FES, in Muscle Activity of the Tibialis Anterior Muscle, Balance and Plantar Pressure Distribution of Individuals With Hemiparesis Due to Stroke

Background: Transcranial direct current stimulation (tDCS) is currently considered a beneficial method for patients with neurological problems due to the modulation of cortex activity as well as the enhancement and prolongation of functional gains achieved during physical therapy. Purpose: The aim of the proposed study is to evaluate the immediate effects of a session of tDCS over the primary motor cortex combined with functional electrical simulation (FES) on electrical activity of the tibialis anterior muscle, balance and distribution of plantar pressure in individuals with hemiparesis stemming from a stroke. A further aim is to determine whether the effects of the combination of both stimulation methods are better than those achieved when each method is employed alone. Methods/design: A randomized, double-blind, crossover, cross-sectional study will be conducted involving 30 stroke survivors with hemiparesis who meet the eligibility criteria. Evaluations will involve an identification and screening chart, the classification of motor impairment using the Fugl-Meyer Scale, the determination of spasticity of the triceps surae muscle (modified Ashworth scale), electromyography of the tibialis anterior muscle, static balance and cognitive dual-task balance (stabilometry) and plantar pressure. After the initial evaluations, the participants will undergo four interventions: 1) anodal tDCS + placebo FES + active tibialis anterior contraction; 2) placebo tDCS + active FES + active tibialis anterior contraction; 3) anodal tDCS + active FES + active tibialis anterior contraction; and 4) placebo tDCS + placebo FES placebo + active tibialis anterior contraction. tDCS will be administered over the primary motor cortex and FES will be administered over the tibialis anterior muscle. The order of the different protocols will be randomized and both the evaluator and patients will be blinded to which protocol is being administered.


Eligibility Criteria:
Inclusion criteria:

* 30 individuals with hemiparesis stemming from a stroke;
* Either gender;
* Able to maintain a standing position without an assistance device for at least 60 seconds;
* Signed statement of written consent.

Exclusion criteria:

* Adverse health condition (beyond hemiparesis) that affects balance;
* Use of medication that can affect balance;
* Positive cutoff point for cognitive deficit (Mini Mental State Examination);
* Illiteracy;
* Wernicke's aphasia;
* Reduced ankle mobility due to history of ankle fracture and use of pins in ankle;
* TA muscle strength less than grade 1;
* Contraindication for tDCS (history of recurrent seizures, recurrent epilepsy and brain tumor in stimulation site);
* Skin infection at tDCS and/or FES site;
* Anesthesia or hyperesthesia at FES site.
Effect of Artemisia Dracunculus on Glucose Intolerance, Insulin Sensitivity and Insulin Secretion

The term prediabetes has been used to encompass the first alterations on glucose metabolism such as impaired fasting glucose and glucose intolerance, and its early detection and treatment could prevent the appearance of diabetes mellitus type 2, a high prevalence disease worldwide.

Artemisia dracunculus, also known as estragon, has been used in Ayurvedic medicine for the treatment of diabetes.

Different in vitro and in vivo studies have shown that Artemisia dracunculus increases insulin signaling and improves insulin sensitivity.

The aim of this study is evaluate the effect of Artemisia dracunculus on glucose intolerance, insulin sensitivity and insulin secretion.

A randomized, double-blind, placebo-controlled clinical trial will be carried out in 24 patients with diagnosis of glucose intolerance in accordance with the criteria of American Diabetes Association (ADA). Glucose, insulin levels, lipid profile, creatinine, uric acid, and transaminases will be evaluated. An oral glucose tolerance test with 75 g of dextrose will be held.

12 participants will receive Artemisia dracunculus, 1000 mg, twice per day (2000 mg) before breakfast and dinner during 3 months. And other 12 patients will receive placebo with the same prescription.

Area Under de Curve of glucose and insulin will be calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).

This protocol is approved by a local ethics committee and written informed consent will be obtained from all volunteers.

Results will be presented as mean and standard deviation. Intra an inter group differences will be tested using the Wilcoxon signed-ran and Mann Whitney U- test respectively; p\<0.05 will be considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Patients both sexes
* Age between 30 and 60 years
* Glucose intolerance according ADA criteria (blood glucose leve ≥140 mg/dl and ≤199 mg/dL after an oral glucose tolerance test with 75 of oral glucose
* Informed consent signed

Exclusion Criteria:

* Women with confirmed or suspected pregnancy
* Women under lactation and/or puerperium
* Hypersensibility to Artemisia dracunculus
* Physical impossibility for taking pills
* Known uncontrolled renal, hepatic, heart or thyroid disease
* Previous treatment for glucose
* Diabetes diagnosis
* BMI ≥39.9 kg/m2
Immunomodulation Using VB-201 to Reduce Arterial Inflammation in Treated HIV - VITAL HIV Trial

This study is a double blinded, placebo-controlled, randomized, parallel group study, designed to compare the efficacy and safety of VB-201 80mg taken orally once daily to placebo for anti-inflammation in HIV-infected subjects.


Eligibility Criteria:
Inclusion Criteria:

* Documented HIV infection
* On continuous antiretroviral therapy and virologically suppressed HIV infection for ≥12 weeks prior to study entry
* CD4 T-cell count \> 350 cells/mm3
* Male or female between the ages ≥ 40 years of age to \<≤75
* Documented cardiovascular disease (1. Prior myocardial infarction, 2. History of percutaneous coronary intervention, 3. History of coronary artery bypass graft OR 4. Angiographic evidence of \>50% stenosis in at least one coronary artery\] OR 1 CVD risk factor (T2DM, current smoking, hypertension, dyslipidemia, hsCRP≥2mg/L, family history)
* TBR of \>1.6 of the MDS of the carotid/aorta at baseline. This baseline arterial TBR cutoff excludes the rare individual that lacks appreciable arterial inflammation. It is notable that while 5-10% of uninfected individuals will have lower TBRs, it is rare that an HIV infected individual will fall below this range.
* Female subjects must either be of non-childbearing potential as defined by menopause with amenorrhea for \>2 years, bilateral oophorectomy, or agree to use adequate contraception throughout the study and for at least one month following termination and have a negative pregnancy test at screening prior to the first dose of drug.
* Males must use at least one method of contraception throughout the study.

Exclusion Criteria:

* Pregnant/nursing women
* Uncontrolled hypertension or diabetes requiring insulin
* AST/ALT or alkaline phosphatase \>2x ULN
* Cancer within the last 5 years with exception of squamous cell carcinoma and basal cell carcinoma
* Nephrotic syndrome or eGFR \<60 mL/min/1.73m2
* Cytopenias which include 1) WBC \<3.5 x103/uL 2) Platelet \<120 x103/uL 3) ANC \<1.5 x103/uL, and absolute lymphocytes \<0.8 x 103/uL
* Anemia as fined by \<10 g/dL
* Evidence of tuberculosis infection at screening within 30 days prior to screening.
* Family history of long QT syndrome, using medication that prolongs QT internal, OR evidence of prolonged QT of \>470 msec as evidenced by ECG
* Acute systemic infection within 30 days
* On additional immunosuppressant or immunomodulatory therapies
A Pilot Trial of a Smartphone-based Self-management Support Program for COPD Patients

COPD patients often experience multiple symptoms (e.g. dyspnea, cough, and deteriorating quality of life) and have imposed a substantial economic and social burden on health care.

The current proposal is to evaluate the feasibility and acceptability of a pilot trial of a smartphone-based instant messaging self-management support program to improve the quality of life in patients with COPD.

Chronic obstructive pulmonary disease (COPD) is the number 3 killer globally by 2020. COPD patients often experience multiple symptoms (e.g. dyspnea, cough, and deteriorating quality of life) and have imposed a substantial economic and social burden on health care.

Current policy for the prevention and management of long-term conditions focuses on efforts to prevent the onset or slow progression of disease early in the disease trajectory. This prevention paradigm has only recently been adopted for COPD. Systematic reviews have shown self-management support for patients with COPD is effective in improving health-related quality of life and in reducing hospital admissions, but the evidence comes largely from patients with moderate or severe disease and is predominantly recruited from secondary care. Simple and systematic strategies are needed to improve out-of-hospital support and management for people living with COPD.

An instant messaging smartphone app, which allows texts, audio, pictures and video messages to be shared in chat groups, is already available to and is the most popular in the Hong Kong general public. Mobile instant messaging can be conducted through a daily use device to increase access and efficacy, which has been suggested as a feasible approach to delivering an intervention with positive effects on health behaviours and outcomes. Text messaging via mobile phones has been shown to be effective in helping promote lifestyle change in diabetes self-management, weight loss, physical activity, smoking cessation and medication adherence with quantitative and qualitative evidence. However, the investigator has not found messaging intervention that was applied in people with COPD, except an ongoing study of using instant text message support for patients with chronic respiratory and cardiovascular diseases.

Hence, the current intervention program is to evaluate the feasibility and acceptability of a smartphone-based instant messaging self-management support program to improve the quality of life in patients with COPD.

Eligibility Criteria:
Inclusion criteria

* Aged 18 years and above
* Diagnosis with COPD
* General condition stable
* Able to speak and read Chinese
* Able to complete the self-administered questionnaire
* Able to use instant messages such as WhatsApp or WeChat
* Mental, cognitive and physically fit for joining the trial as determined by the clinician or responsible investigator
* Signed informed consent

Exclusion criteria

* Skeletal fragility
* Serious active infection
* Inability to walk
* Severe respiratory insufficiency
The Outcomes of Keystone Perforator Island Flap Versus Lay Open in Re-recurrent Pilonidal Sinus Disease

Pilonidal disease is a common and annoying problem with a fair recurrence rate. Every time of recurrence more skin is needed to cover the defect and if left open healing is supposed to be prolonged.


Eligibility Criteria:
Inclusion Criteria:

* re-recurrent pilonidal disease

Exclusion Criteria:

* patients with proved anal or perineal malignancy or autoimmune disease
* patient with pilonidal disease for the first time or for the first time of recurrence
TVMR With the Innovalve System Trial - Early Feasibility Study

Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Eligibility Criteria:
Inclusion Criteria:

* Clinically significant, symptomatic mitral regurgitation
* High risk for open-heart surgery
* Meets anatomical criteria

Exclusion Criteria:

* Unsuitable anatomy
* Patient is inoperable
* EF\<25%
A Safety and Effectiveness Study of JUVÉDERM VOLBELLA® XC Injectable Gel for Lip and Perioral Enhancement

This is a multicenter, double-blind, randomized, controlled study of the safety and effectiveness of JUVÉDERM VOLBELLA® XC Injectable Gel versus Restylane-L® for lip and perioral enhancement.


Eligibility Criteria:
Inclusion Criteria:

* 22 years of age or older
* Has a score of minimal, mild, or moderate on the LFS2, as agreed upon by the Treating and Evaluating Investigators, and desires at least 1 point of correction for one or both lips
* For treatment of perioral lines, has a POLSS score of severe or moderate as agreed upon by the Treating and Evaluating Investigators (all subjects are eligible for treatment in the vermilion body, oral commissures, vermilion border, Cupid's bow, and philtral columns)

Exclusion Criteria:

* Has lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments
* Has dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities as judged by the Treating Investigator
* Has undergone oral surgery (e.g., tooth extraction, orthodontia, or implantation) within 6 weeks before enrollment or is planning to undergo any of these procedures during the study
* Has ever undergone facial plastic surgery or received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted with any of these products during the study
* Has undergone semipermanent dermal filler treatment (e.g., calcium hydroxylapatite, poly-L-lactic acid) in the lower face (below the orbital rim) within 24 months before enrollment or is planning to undergo such treatment during the study
* Has undergone temporary dermal filler treatment (e.g., hyaluronic acid or collagen) in the lower face (below the orbital rim) within 12 months before enrollment or is planning to undergo such treatment during the study
* Has undergone mesotherapy or cosmetic resurfacing (laser, photo-modulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) anywhere in the face or neck, or Botulinum toxin injections in the lower face (below the orbital rim) within 6 months before enrollment or is planning to undergo any of these procedures during the study
A Study To Examine The Distribution Of PF-05212377 In The Brain Of Healthy Volunteer Subjects Using Positron Emission Tomography And A Radioactive Tracer Following Oral Administration Of One Dose Of PF-05212377

This study will see how PF-05212377, an experimental drug to treat symptoms from Alzheimer's Disease, distributes in the brain after one dose of PF-05212377 is administered orally to healthy volunteer subjects. The study will also evaluate the safety and tolerability of PF-05212377 in these subjects and will measure the level of PF-05212377 in the blood.


Eligibility Criteria:
Inclusion Criteria:

* Males and females must be at least 18 years of age and no older than 55 years of age with a Body Mass Index (BMI) must be between 17.5 and 30.5.
* Subjects must sign a consent form and comply with all scheduled visits, treatment plan, lab tests and other study procedures.

Exclusion Criteria:

* Females must not be pregnant, breastfeeding, or able to have children.
* Subjects must not have a severe acute or chronic medical or psychiatric condition history or evidence of blood, kidney, glandular, lung, stomach, intestine, heart, blood vessel, liver, psychiatric, nerve, or allergic problems (including drug allergies), except mild seasonal allergies.
* Subjects must not drink alcohol excessively or take illicit drugs.
* Male subjects use condoms to prevent the potential transfer of drug through the semen to their partner beginning with the dose of study drug and use a highly effective method of birth control with any partner(s) of childbearing potential through 28 days after the last dose.
Construction of an in Vitro Intestinal Microbial Ecological Simulation System for Obese People

About 2.6 billion people ( about 40 % of the world 's population ) are affected by overweight or obesity. The prevalence of overweight and obesity in Chinese adults has exceeded 50 %, and the prevalence is still on the rise.The gut microbiota is regarded as an endocrine organ and participates in energy balance. Diet changes can disrupt the relationship between the microbiota and the host, leading to metabolic diseases.Although human studies provide important information, there are limitations, such as the entry of complex gastrointestinal environment limiting components, the lack of dynamic microbial process information, and the uncertainty of drug side effects. In vitro methods can solve these problems, allowing dynamic sampling, standardized operation, high repeatability, and evaluation of potential toxins and pathogens. In vitro models are widely used to evaluate the effects on the human colon microbiome and to predict in vivo results.Based on the above research background, this study aims to collect fecal samples from obese people to construct an in vitro intestinal microbial ecological simulation system. This will lay an experimental foundation for further exploring the effect of specific nutrient intervention on the composition and function of gut microbiota in obese people.


Eligibility Criteria:
Inclusion Criteria:

* Screening in the physical examination population who intend to retain fecal samples in the physical examination center of our hospital. BMI ≥ 28, age range from 18 to 30.

Exclusion Criteria:

* Previous history of intestinal disease, history of hypertension, diabetes, coronary heart disease and other chronic diseases, history of important organ disease or surgery, history of malignant tumor disease.
* He had a history of heavy smoking and alcohol abuse.
* In the past 6 months, she took antibiotics.
* Weight loss measures in the past 6 months, including but not limited to dieting, physical exercise, probiotic intervention and other medications.
* Subjects and their families who disagreed with the study protocol.
Evaluation of Long-term Health Status and Quality of Life in Adult Survivors With Philadelphia-negative Acute Lymphoblastic Leukemia/Lymphoma Treated With an Intensive Pediatric or Pediatric-inspired Protocol

The overall survival of adult patients (15-59y) with Philadelphia-negative acute lymphoblastic leukemia/lymphoma (ALL/LL) was dramatically improved by the use of full pediatric or pediatric-inspired protocols (GRAALL2003/05-LL03-FRALLE2000) that aimed to reduce the risk of relapse by adopting more intensive chemotherapeutical schedule. This approach led to a global improvement in overall survival (5y-OS, 57%) whatever patient age but was responsible for an excess of treatment-related mortality in patients older than 45 years (5y-TRM in patients \> 45y, 19%). Pediatric longitudinal studies pointed out that long term leukemia survivors have an increased risk of developing specific adverse events like dysmetabolic syndrome, obesity, decreased fertility, organ dysfunction, osseous events, or impaired cognitive functions. This study aims to evaluate the impact in term of long-term events and QoL in adult patients that received an intensified therapeutic approach recently implemented in adult cooperative groups. The main objective of this study is to evaluate the prevalence of late effects in adult patients treated 10 years ago for ALL/LL with an intensified pediatric-inspired protocol (GRAALL2003/05-LL03-FRALLE2000) that exposed patients to increased cumulative doses of chemotherapy, central nervous system irradiation or w/o allogeneic transplant after total body irradiation-based regimen w/o boost irradiation on central nevous system. One of the secondary endpoint of the study is to assess quality of life of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient with Philadelphia-negative ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
* Patients older than 15 years old and less than 60 years old at diagnosis
* Patient with a follow-up from first complete remission of more than 10 years,
* Patient who gave informed signed consent for baseline examination

Exclusion Criteria:

* Patient who experienced ALL/LL relapse within the 5 past years.
* Philadelphia positive ALL patients