cyrilzakka/clinical-trials huggingface dataset:
Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants

Prospective observational clinical follow-up of Euromi Biosciences silicone gel-filled breast implants - Post-market clinical investigation - ELEGANT


Eligibility Criteria:
Inclusion Criteria:

* Female;
* 18 years old and above, and under 60 years old;
* has approved and signed the informed consent form;
* eligible to receive at least one EUROMI Biosciences implant during breast reconstruction following a mastectomy or during aesthetic breast surgery;
* Willing to be followed up for a period of 10 years.

Exclusion Criteria:

* Informed pregnancy or breastfeeding at the time of inclusion
* Known hypersensitivity and / or allergy to silicone;
* Not understanding or not accepting the risks of further surgeries during follow-up;
* Body mass index \> 40 kg/m²;
* Diabetes
* HbA1c levels \> 7,5%;
* History of repeated failure with the implantation of similar implants;
* Tissue or fat insufficiency;
* Progressive breast cancer large tumours (\>5 cm), late cancer stage and deep tumours;
* Grossly positive axillary involvement / or chest wall involvement;
* High risk of cancer recurrence;
* Tissue damage in the implant area due to irradiation of the thoracic wall;
* Pre-existing pathology in the implant area;
* General infection or infection in the implant area;
* Medical condition (poor physiological condition, psychological instability, severe smoking, obesity, coagulopathy, diabetes, severe cardiovascular or pulmonary disease, etc.) Which may, according to the judgement of the surgeon, entail excessive risk and/or post-surgical complications;
* History or presence of an autoimmune disease;
* Immunocompromised;
* History or current treatment using radiation with lower-pole scarring and thin, poorly vascularized skin/tissue / microwave diathermy / or steroids;
* Medical condition likely to interfere with her capacity to understand the follow-up requirements, to participate in the follow-up or to give her informed consent;
* Concomitantly part of another interventional clinical trial.
* Under supervision or legal guardianship
* Deprived of liberty by a judicial or administrative decision
* Not affiliated to health insurance system or is a beneficiary of such coverage
Macronutrients and Gut Hormone Secretion

Study hypothesis is to examine the relative contribution of macronutrients for gut hormone secretion after a mixed meal in healthy volunteers and in subjects with type 2 diabetes. Individual macronutrients or a mixed meal will therefore be served and gut hormones are measured during the following 300 min.

In healthy volunteers and subjects with dietary regulated diabetes mellitus, glucose, protein mixture or fat emulsion will be served individually and on a separate occasions a mixed meal will be served. Samples will be taken during the following 300 min. Concentrations of the gut hormones glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1, insulin and glucagon will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Healthy status or type 2 diabetes with dietary regulation

Exclusion Criteria:

* Liver disease
* kidney disease
* thyroid disease
Ultra-low Dose Oral Ketamine for Chronic Pain in the Primary Care Setting

This project is a pilot study to evaluate the analgesic and opioid-sparing effects of ketamine in an ultra-low dose oral formulation as a novel intervention for treatment of chronic non-cancer pain in opioid-tolerant patients in the primary care outpatient setting.

Chronic pain is a major national public health issue, affecting about 100 million adults in the United States. Opioid pain medications are commonly used for treatment of chronic pain, but their use is fraught with consequences including an increasing prevalence of misuse, abuse, and overdose death, and side effects which lead to a reduced quality of life. An effective and safe medication that would improve control of chronic pain while reducing reliance on opioid medications would be valuable for patients, medical providers and society at large.

Ketamine, commonly used as an intravenous anesthetic agent, has been shown to have analgesic and opioid-sparing effects in the peri-operative period and in the palliative care setting. Based on promising preliminary data from an open-label treatment trial, this project is a pilot study to evaluate the analgesic and opioid-sparing effects of ketamine in an ultra-low dose oral formulation as a novel intervention for treatment of chronic non-cancer pain in the primary care outpatient setting.

The design of the proposed study is a randomized controlled two week parallel-group trial, with 32 patients receiving either the active treatment or placebo twice daily.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Routine use of an opioid medication for non-cancer pain for more than six months
* A current average daily dose of greater than or equal to 20 mg morphine or equivalent
* Current prescription of an as-needed opioid suitable for downward titration during the study period
* Ability to provide informed consent Ability to adhere to the study protocol

Exclusion Criteria:

* Uncontrolled hypertension, cardiac arrhythmia or other known cardiac disease,
* elevated intracranial pressure,
* severe glaucoma,
* schizophrenia,
* diagnosed substance use disorder, or
* other unstable medical or psychiatric illness or pregnancy.
Evaluation of Keyo in Children With Epilepsy

To evaluate the tolerance, acceptability and compliance of Keyo in 20 subjects aged 3 years and over, with intractable epilepsy or Glut-1 DS on a KD.

Qualitative assessments from subject questionnaires that allow evaluation of the acceptability and ease of use of the study product.

Collection of daily data about the gastro-intestinal tolerance of the study product.

Collection of daily data about compliance with the study product i.e. actual versus prescribed intake.

Improve quality of life by increasing range of foods available for use in a ketogenic diet.

Eligibility Criteria:
Inclusion Criteria:

* 3 years and over
* Confirmed diagnosis of intractable epilepsy or Glut-1 DS
* Children must be currently established on a KD for at least 3 months, taken orally
* Written, informed consent by participant/carer

Exclusion Criteria:

-
Implementing HCV Treatment for High-risk Populations in Austin, Texas

Highly-effective, pan-genotypic direct acting antivirals (DAAs) have made elimination of hepatitis C virus (HCV) a real possibility. A minority of the population infected with HCV has access to care or been prescribed such HCV treatment. Among people experiencing homelessness in the US, and seeking care at Health Care for the Homeless (HCH) clinics, prevalence is 31%, and 70% among people who experience homeless and inject drugs. In N. America, 55% of people who inject drugs (PWID) have HCV. Austin, TX has over 7,000 people experiencing homelessness with about 20% having a substance use disorder.

Treatment of HCV via DAAs is feasible and effective in primary care settings, and is as effective as treatment by specialists. Among people with opioid use disorder receiving opioid agonist therapy it's both effective and cost-effective. Treatment in the primary care setting has also been shown to be feasible and effective for people experiencing homelessness, with supporting evidence of engaging and retaining people in care. Furthermore, a novel HCV treatment model, featuring a simplified HCV treatment algorithm for front-line health care providers (primary care physicians, Nurse Practitioners, Physicians Assistants), has now been published, to help increase capacity, scale-up treatment and achieve elimination.

This study takes the foregoing new simplified approach one step further: Implementing this simplified algorithm for front-line health care providers in primary care settings caring for high-risk populations such as individuals experiencing homelessness and PWID. The novelty is providing treatment in diverse primary care settings, and targeting clinical sites serving high-risk populations, including people experiencing homelessness and PWID. Investigators use an implementation science approach to study the feasibility and effectiveness of the HCV treatment model in achieving HCV cure in high-risk populations.

Investigators hypothesize that by training front-line health care providers on a simplified, low-barrier HCV treatment model and adapting it using a locally contextualized, protocol-driven approach, investigators will effectively scale up HCV treatment across multiple primary care clinical sites serving high-risk populations, yielding sustained virologic response at 12 weeks (SVR-12) in 75% of enrolled participants. Investigators predict theHCV treatment model to measure favorably across implementation process and outcome measures of reach, adoption, implementation, and maintenance.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients age 18 years and older.
* Enrolled in care at one of CommunityCare's clinical sites participating in the study.
* Laboratory diagnosis of HCV
* Chronic hepatitis C infection

Exclusion Criteria:

* Have decompensated cirrhosis.
* Have received hepatitis C treatment previously.
* Had a liver transplant or actively on the transplant list awaiting a liver transplant.
* Have resistant HCV virus
* Infected with HIV
* Infected with hepatitis B
* Currently pregnant
Observational Prospective Study OPTIMA II - Follow-up

The current follow-up study was planned to reveal the rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) during 4-year follow-up in patients participated in OPTIMA study. In addition, the long-term effects of statins on LDL-cholesterol and different biomarkers in patients after drug-eluting stents implantation will be assessed. In addition, such project implementation will allow to clarify the treatment options used by Russian patients with CAD (Coronary Artery Disease) after drug-eluting stent implantation. The information received in this study will help to optimize management of Russian patients with CAD after PCI in order to improve prognosis and quality of life of these patients.

This project is 3-years follow-up of OPTIMA study. This is an observational retro-prospective study based on the data collected during one visit: 4-year after PCI performed at the Russian Cardiological Research Center (РКНПК). From the date of the study start and until the end of the study investigators will enroll those patients participated in OPTIMA study. Only patients, who consent to participate in the study and sign the informed consent form after being informed by a physician on the objectives and methods of the study, will be enrolled into this project.

This study is an observational one, and there is no intervention into routine clinical practice either in terms of therapy, or special examinations. The main point of this project is the data collection using the out-patient medical records or disease history of a patient, as well as collection of data received during patient routine examination. Data collection will be performed only once during single routine patient visit to treating physician or hospitalized patient examination. Study participation will be finished after this visit. Data collection will be performed at the visit 4 years after PCI and will include medical history, current medications, physical examination, ECG (electrocardiogram) and laboratory assessments.

The study will be conducted in Russian Federation. It is planned that 80-90% of patients participated in OPTIMA study will be enrolled into current project. One clinical site - Russian Cardiological Research Center (РКНПК) - is supposed to participate in this study.

The total period of the study is anticipated to be about 18 months.

Eligibility Criteria:
Inclusion Criteria:

1. Participation in OPTIMA study;
2. Written informed consent provided prior the start of follow-up in the study

Exclusion Criteria:

1. Lost to follow-up patients of OPTIMA study;
2. Subjects who are unwilling or unable to provide informed consent.
The Effect of Momordica Charantia Supplementation on Blood Glucose Levels

The study is a randomized, cross-over, double blind, controlled trial in which study participants will receive two 4-week interventions with a washout period of 4 weeks between interventions. Study subjects will visit the research facility before and after each intervention period for a test day. In the third intervention week participants are provided with a 3-day controlled diet and glucose responses will be monitored via a continuous glucose monitoring device.

Bitter gourd (BG) (Momordica charantia), is a highly nutritive vegetable from the cucumber family. The objective is to assess the impact of 4-week BG supplementation on blood glucose levels and glucose tolerance in subjects with an impaired fasting glucose or with an impaired glucose tolerance and to evaluate how BG supplements modulate glucose response curves during meal intake. The study is a randomized, cross-over, double blind, controlled trial in which study participants will receive two 4-week interventions with a washout period of 4 weeks between interventions. Study subjects will visit the research facility before and after each intervention period for a test day. In the third intervention week participants are provided with a 3-day controlled diet and glucose responses will be monitored via a continuous glucose monitoring device. The intervention will be a 4-week intervention with 2.4g/d dried bitter-gourd supplements and a reference intervention with 2.4g/d dried cucumber supplements. The main study parameter is fasting levels of plasma glucose and 2hour plasma glucose after a 75-gram OGTT.

Eligibility Criteria:
Inclusion Criteria:

* age 50-75yrs
* BMI \>25 kg/m2
* Having veins suitable for blood sampling via a catheter
* Having one or more of the following criteria:

  * HbA1c \> 5.7%
  * fasting glucose \>5.6mmol/L
  * two-hour glucose levels \>7.8 mmol/L on the 75-g oral glucose tolerance test .

Exclusion Criteria:

* History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
* History of liver dysfunction (cirrhosis, hepatitis) or liver surgery
* Kidney dysfunction (self-reported)
* Use of medication/supplements that may influence the study results, such as medicines known to interfere with glucose homeostasis.
* Anaemia (Hb values \<7.5 for women and \<8.5 for men)
* Reported slimming, medically prescribed or other extreme diets
* Reported weight loss or weight gain of \> 5 kg in the month prior to pre-study screening
* Not willing to give up blood donation during the study
* Current smokers
* Alcohol intake ≥4 glasses of alcoholic beverages per day
* Abuse of illicit drugs
* Food allergies for products that we use in the study
* Participation in another clinical trial at the same time
* Being an employee of the Food, Health \& Consumer Research group of Wageningen Food \& Biobased Research or dept. human nutrition and health of Wageningen University.
Efficacy of Noisome as A Carrier of Locally Delivered Minocycline Hydrochloride Gel

The goal of this clinical trial is to compare the efficacy of Noisome as carrier of minocycline hydrochloride gel to minocycline hydrochloride in Stage II or Stage III Periodontitis . The main questions it aims to answer are:

* Is the Noisome carrier of minocycline hydrochloride has an effect in comparing to minocycline hydrochloride in Stage II or Stage III Periodontitis?
* what is the release profile of of minocycline hydrochloride noisome gel and minocycline hydrochloride gel? Participants will be asked to maintain oral hygiene after application of treatment Researchers will compare the effect of noisome as a carrier of locally delivered minocycline hydrochloride gel to minocycline hydrochloride gel in stage II or stage III periodontitis patients as an adjunct to non-surgical periodontal treatment\] to see if Plaque Index (PI) , Gingival index,Clinical attachment level (CAL) \&Periodontal Pocket Depth decreased or not.

This study is designed to be a Randomized, Controlled, blinded, clinical trial; the eligible participants will be randomly allocated for one of the two comparative parallel-Groups; test and control group . The interventions will be prepared by the pharmacist and coded and the whole-time frame for the study will be 18 weeks.

The intervention to all participants will be Non-surgical debridement the the test group will receive the Noisome minocycline hydrochloride \& control group will receive minocycline hydrochloride.

Eligibility Criteria:
Inclusion Criteria:

* Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study.
* Generalized Periodontitis (Stage II or stage III ) Patients; ( ≥ 3 mm CAL, PD 5-7 mm ) , premolar-molar area (test site) .
* Having more than 16 tooth excluding wisdom and test teeth that still had both mesial and distal neighboring teeth.
* Systemically free according to the modified Burkitt's health history questionnaire

Exclusion Criteria:

* Non-surgical periodontal therapy within the previous 12 months, systemic or local use of antibiotics with the previous 3 months, medication with possible influence on the periodontium.
* Pregnancy or contraceptives usage.
* Breastfeeding.
* Known allergy to the ingredients of the treatment.
* Smokers.
* vulnerable group; prisoners \& orphans .
Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose

Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose

A Phase I, Double blind, Placebo-controlled, safety and tolerability study of ZP1848 administered as Ascending single Dose, SUBCUTANEOUS bolus injections in healthy SUBJECTS followed by a Multiple Dose cohort of patients with stable Crohn's disease in remission

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male and/or females, 18 to 50 years of age
* Body mass index (BMI)18-30. Chrons Inclusion
* Adult male and/or females, 18 to 60 years of age (inclusive).
* Body mass index (BMI) ≥ 18 and ≤ 30 (kg/m2).
* Crohn's Disease Activity Index (CDAI) score \< 150.
* In a stable state of Crohn's disease as per the Investigator's opinion.
* Free of steroid treatment (therapy targeted for the GI tract only) within the 3 months prior to Day 1.

Exclusion Criteria:

* History or presence of dysplasia, cancer, chronic hepatitis, HIV, tuberculosis (TB), or histoplasmosis.
* Fistula within the 3 months prior to dosing. 3. Ostomy (having ostomy now or at any time in the past). 4. Any surgery for the treatment of inflammatory bowel disease (IBD) within the 3 months prior to Day 1. 5. Short Bowel Syndrome (SBS). 6. Any other condition, chronic disease, or prior therapy, which in the opinion of the Investigator/Investigator's designee would put the patient at undue risk or would make the patient unsuitable for the study.
NicVAX/Placebo as an Aid for Smoking Cessation

The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.


Eligibility Criteria:
Inclusion Criteria:

* Current smoker who smokes at least 10 cigarettes a day during the past year and wants to quit smoking.
* Smokers who are in good general health.

Exclusion Criteria:

* Prior exposure to NicVAX or any other nicotine vaccine.
* Use of systemic steroids.
* Cancer or cancer treatment in last 5 years.
* HIV infection.
* History of drug or alcohol abuse or dependence within 12 months.
* Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease.
* Inability to fulfill all visits for approximately 52 weeks.
OGT Spray in the Management of Xerostomia in the Elderly

The primary objective of the trial is to evaluate the efficacy, safety and clinical acceptability of OGT oromucosal spray in the relief of symptoms and signs of xerostomia in comparison with a saliva substitute (European Medical Device).

Xerostomia is excessive dryness of the mouth. It is due to insufficient (hyposialism) or inexistent (asialia) saliva secretion.

There are many causes. Transitory xerostomia may occur in the presence of anxiety (stage fright, fear or dehydration). Prolonged xerostomia is most often related to a systemic disease, certain medicines or to radiotherapy of the head or neck.

Xerostomia is often accompanied by buccal symptoms and signs such as impaired sense of taste, fetid breath and mouth ulcers, and it disturbs functions such as speech, chewing and swallowing. Because of reduced salivary secretion, there is disturbance of the microbial colonization of the buccal cavity, increased demineralization and decreased remineralization of the teeth, impaired retention of dentures, dehydration of the mucosa and reduced lubrication of the buccal mucosa. These complications may take the form of dental caries, candidiasis, atrophy and feelings of burning of the mucosa, difficulty retaining dentures, impaired speech and swallowing and impression of decreased or impaired sense of taste. Xerostomia has significant harmful effects on the buccal cavity and on the quality of life of patients.

Xerostomia prevalence rates of the order of 18-61% have been reported in the elderly. These rates are generally higher in women that in men and increase with age. They are also higher in populations in institutions and in those taking multiple medications. Wearing a denture, stress and other psychological factors have also been suggested as factors increasing risk or or worsening xerostomia.

Treatments of xerostomia are saliva substitutes and saliva stimulants.

OGT Spray is neither a substitute nor stimulant of saliva.

OGT Spray is a solution for oromucosal spray which has lubricant and protective actions.

The aim of the study was to demonstrate that OGT Spray (oral lubricant) was effective in the subjective relief of dry mouth symptoms and objective signs of dry mouth in elderly.

Eligibility Criteria:
Inclusion Criteria:

* male or female, institutionalized and at least 70 years of age
* with a diagnosis of xerostomia confirmed objectively by the saliva absorption test
* having stopped all palliative treatment for xerostomia
* legally capable of giving consent
* capable and agreeing to participate in the study and capable and accepting to answer study questionnaires in accordance with the terms of the French Huriet Act on clinical trials,
* remaining in the establishment throughout the study period

Exclusion Criteria:

* Concomitant treatments incompatible with the trial, especially alcoholic solutions
* buccal fungal infection
* systemic infection or current dental care
* current participation in other clinical trials
* allergy or known intolerance to one of the constituents of the trial products
* treatment with atropine
* presence of active life-threatening disease