cyrilzakka/clinical-trials huggingface dataset:
Effect of Acute Red Raspberry Consumption on Post-prandial Oxidative Stress

Eight healthy adult subjects will be given a meal of one, two or four cups red raspberries, or two slices white bread with or without 200 mg vitamin C, after an overnight fast and consumption of a low polyphenol diet for two days. Blood samples will be taken at various time points over an eight hour period to measure oxidative stress and antioxidant levels in the blood. Each subject will attend 5 study visits with one week intervals and be given each meal in a random order. It is hypothesized that raspberry consumption at higher doses will greater protect against meal-induced oxidative stress compared to bread controls.


Eligibility Criteria:
Inclusion Criteria:

* healthy adults

Exclusion Criteria:

* blood pressure greater than 120/80 mm Hg
* body mass index greater than 24.9 kg/m\^2
* history of any chronic disease
* currently taking medications
* allergy to fruit
Accuracy of Guided Implant Placement Using Double Versus Triple Scan Protocol in Completely Edentulous Patients

16 implant placement by surgical guide using double scan protocol versus triple scan protocol to Evaluate angular and linear deviation of virtual implants and actual implant position in completely edentulous patients according to scanning protocol C1(double scan technique) and C2 (triple scan technique) .

In this study we discuss linear and angular deviation of actual implant position using planning protocol C1(double scan technique) or C2 (triple scan technique) in completely edentulous patient .

Both protocols C1(double scan technique) and C2 (triple scan technique) indicated in completely edentulous patient and require C.T scan for patient wearing scan appliance .

In C1(double scan technique) , after CT scan for patient wearing scan appliance , two optical scan for the model with and without scan appliance.

In C2 (triple scan technique) , after CT scan for patient wearing scan appliance , CT scan for scan appliance alone .

Teeth positions in both protocols were identified by radio-opaque scan appliance .

16 implant placement by surgical guide using double scan protocol versus triple scan protocol ( two groups - 8 implants in each group ) to Evaluate angular and linear deviation of virtual implants and actual implant position in completely edentulous patients according to scanning protocol C1(double scan technique) and C2 (triple scan technique) .

Eligibility Criteria:
Inclusion Criteria:

1. patients totally edentulous arches.
2. patients with Bucco-lingual bone thickness \>6 mm allowing flapless implant placement
3. patients free from any systemic diseases that may affect bone quality e.g diabetes.

Exclusion Criteria:

1. patients with thin ridges.
2. patients with systemic disease that may affect bone quality.
3. Patients with poor oral hygiene and active periodontal diseases.
4. Anatomical situations requiring regenerative procedure.
Effect of Costal Harvesting Technique on Postoperative Donor-site Morbidity: Does Muscle Sparing Technique Cause Less Postoperative Pain ? A Clinical Trial

The purpose of this study was to investigate the effect of 'muscle sparing technique' while harvesting costal/rib cartilage on postoperative donor-site morbidity -namely postoperative pain. Although authors report 'muscle sparing technique' cause less pain its not investigated in an evidence-based-medicine perspective. Therefore the investigators are planning a controlled, prospective clinical trial to compare the conventional method and 'muscle sparing technique'.

Effect of Costal Harvesting Technique on Postoperative Donor-site Morbidity: Does Muscle Sparing Technique Cause Less Postoperative Pain ? A Clinical Trial

Revision rhinoplasty patients requiring costal cartilage were enrolled in the study. All costal cartilage harvestings were full-thickness and they were carried out by a single-surgeon (Berke Ozucer). Patients were randomly assigned either to 'Conservative Muscle-cuttingHarvesting Technique' or 'Muscle-sparing Harvesting Technique'.

Surgical technique costal cartilage harvesting in both groups were identical expect this:

M-Cutting group : Following skin incision with No.15 blade; all layers including the subcutaneous fat, muscle fascia and muscles covering the cartilage were cut with Monopolar electrocautery at (25 watts).

M-Sparing group: : Following skin incision with No.15 blade; all layers including the subcutaneous fat, muscle fascia and muscles covering the cartilage were passed with blunt dissection. Muscle fibers were dissected parallel to their positioning.

Postoperative pain was evaluated with a Visual Analogue Scale. Participants were questioned regarding their donor-site pain and asked to score their pain 0 (minimum and 10 (maximum). Passive state and pain while active was evaluated separately. This evaluation was carried out at 6th postoperative hour, first, second, third postoperative-days, first postoperative week, on 15th ,30th and 45th day postoperatively. Also postoperative need for analgesics were also noted for the first three days.

Muscle-cutting and muscle-sparing groups were analysed for mean ± Standard deviation values. These values were compared statistically to assess whether muscle-sparing technique has a significant effect on reduced postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* Revision rhinoplasty
* when costal cartilage is harvested full-thickness

Exclusion Criteria:

* Fibromyalgia
* No consent
* When patient does not comply with follow-up
At-Home Research Study for Patients With Autoimmune, Inflammatory, Genetic, Hematological, Infectious, Neurological, CNS, Oncological, Respiratory, Metabolic Conditions

We are the missing link in clinical trials, connecting patients and researchers seamlessly and conveniently using a mobile health platform to advance medical research. We make it easy for patients to contribute to research for medical conditions that matter most to them, regardless of their location or ability to travel.

This study will collect blood and other optionally donated tissue samples from people with all different types of health conditions, as well as healthy control samples, in order to provide biomedical researchers with quality biospecimens that are necessary in translating basic science research into clinically relevant information and technology.

Eligibility Criteria:
Inclusion Criteria:

* All adults 18-100 years old
* Able to provide proof of diagnosis
* Live in USA

Exclusion Criteria:

* Younger than 18 years old
* Receipt of blood products within 30 days of study blood collection
* Receipt of investigational drug within 30 days of study blood collection
Impacts of the Covid-19 Epidemic and Associated Lockdown Measures on the Management, Health and Behaviors of Cystic Fibrosis Patients During the 2020 Epidemic

Impacts of the Covid-19 epidemic and associated lockdown measures on the management, health and behaviors of cystic fibrosis patients during the 2020 epidemic

The containment of the population in France is a health measure implemented in response to SARS-CoV-2 (Covid-19) infection. For cystic fibrosis, as for many chronic diseases, this disruption is twofold. On the one hand, it affects daily life due to the closure of schools and the introduction of national lockdown, but also the hospital, which has profoundly changed its procedures, which are almost completely focused on the care of patients with Covid-19. This forced transformation was at the expense of its usual role including the management of chronic diseases such as cystic fibrosis. It has an impact on patients' consultations cancelled, rescheduled or replaced by teleconsultations, hospitalisations whether scheduled or during acute exacerbations which are more complicated to organise. Access to treatments is also more difficult (physiotherapy), which can affect compliance. Confinement also profoundly changes the lives of our patients. It changes the way individuals can apprehend their disease and its integration into their everyday life, studies or professional projects. Finally, it is the confrontation with a potentially fatal infection that reminds us of the risks and consequences of a potentially severe chronic disease.

Eligibility Criteria:
Inclusion Criteria:

* Patient with cystic fibrosis (Southern Chlorine \> 60 mEq/L and/or presence of 2 pathogenic mutations on the CFTR gene)
* Supported in a French CRCM (Cystic fibrosis Resource and Competence Center)
* Affiliated to a social security scheme
* Non-opposition for participation in the protocol

Exclusion Criteria:

* Minor patient under 14 years of age
* Computer equipment or internet connection defect
Treatment for Opioid Dependent Offenders

This pilot study is examining the feasibility of a primary care and a specialist treatment (methadone clinic) model of treatment for 15 offenders who are part of two community supervision programs: Drug Court and the Treatment Alternative Program (TAP) in Dane County. The questions addressed by future larger studies based upon the current pilot-feasibility study will center around whether access to primary health care as opposed to more traditional methadone treatment services will improve the health and criminal justice outcomes for participants.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of opioid dependence
* opioid positive urine drug screen
* participation in local Drug Treatment Court or Treatment Alternative Program
* women of childbearing potential who have a negative screening urine pregnancy test and are willing to use appropriate birth control methods during the duration of the study

Exclusion Criteria:

* current alcohol or sedative dependence
* pregnancy
* women who are currently breast-feeding
* complex psychiatric co-morbidity (e.g. suicidality, psychosis)
* complex medical co-morbidity (e.g. major cardiovascular, renal, or gastrointestinal/hepatic disease)
* current pharmacotherapy with an agent which is contraindicated in combination with Suboxone or methadone according to drug labeling
* paralytic ileus, coronary artery disease or heart arrhythmia, recent head injury, obstructive sleep apnea, severe asthma or COPD, end-stage renal disease, or severe morbid obesity
Specified Drug-use Survey of Leqvio for s.c. Injection.

The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice

Uncontrolled, central registration system, multicenter, special drug use-results surveillance.

This is a prospective, open-label, multicenter, single-arm observational study (non-interventional study: NIS) conducted only in Japan.

The survey will include patients with familial hypercholesterolaemia or hypercholesterolaemia who have received treatment with Leqvio. Patients who discontinued treatment with Leqvio before completing the 24-month observation period will be followed for safety until the date of the last dose of Leqvio plus 180 days or until 24 months after the first dose of Leqvio, whichever comes earlier.

Eligibility Criteria:
Inclusion Criteria:

* Patients who provided written informed consent to participate in this survey prior to the start of treatment with Leqvio.
* Patients who received treatment with Leqvio as per the package insert.

Exclusion Criteria:

* Patients who received treatment with a formulation containing the same ingredients as Leqvio in the past.
* Patients participating in other interventional studies at the time of informed consent.
* Patients planning to participate in other interventional studies during this survey.
Predictive Role of Circulating Angiogenic Factors for Second-line Paclitaxel and Ramucirumab.

The project is primarily aimed at identifying and subsequently validating the predictive role of plasma concentrations of VEGF-A (vascular endothelial growth factor A), VEGF-D (vascular endothelial growth factor D) and s-VEGFR2 (soluble Vascular Endothelial Growth Factor Receptor 2) measured prior to initiation and during second-line treatment with paclitaxel and ramucirumab in patients with unresectable gastric cancer pretreated with first-line chemotherapy.

For the primary endpoint, the efficacy parameter chosen is PFS, calculated from day 1 of treatment to date of progression or death.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed carcinoma of the stomach, cardia or gastroesophageal junction;
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1;
* Life expectancy \>3 months;
* Age \>18 years;
* Metastatic disease measurable or evaluable according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1;
* Progression after previous first-line treatment with fluoropyrimidines and platinum derivative; previous neoadjuvant/adjuvant treatment terminated ≤6 months after instrumental evidence of relapse will be considered first-line treatment;
* Prior treatment with trastuzumab in case of HER-2 (human epidermal growth factor receptor 2) positive disease, defined as a 3+ immunohistochemistry (IHC) or 2+ IHC score and subsequent gene amplification demonstrated by Fluorescent In Situ Hybridization (FISH);

Exclusion Criteria:

* Previous treatment with ≥2 lines of systemic therapy for metastatic disease;
* Symptomatic peripheral neuropathy ≥2 grades according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03;
* Uncontrolled infections in active phase, disseminated intravascular coagulation in activity;
* Clinically significant cardiovascular disease, such as cardiovascular accidents (less than 6 months after initiation of treatment), myocardial infarction (less than 6 months after initiation of treatment), unstable angina, chronic heart failure ≥2 New York Heart Association (NYHA) grade, uncontrolled arrhythmias;
* Past (within 2 years of treatment initiation, except for curatively treated basal or squamous cell carcinomas of the skin or carcinoma in situ of the cervix) or current history of malignancy other than gastric cancer.
A Study on The Effect of Hepatic Impairment on The Pharmacokinetics of RO4917838

This open-label, single-dose, parallel group study will assess the pharmacokinetics and safety of RO4917838 in healthy volunteers and patients with mild, moderate or severe chronic hepatic impairment. Patients and healthy volunteers will receive a single oral dose of RO4917838.


Eligibility Criteria:
Inclusion Criteria:

General:

* Body mass index (BMI) between 18 and 32 kg/m2 inclusive

Healthy Subjects:

* Adult male or female subjects, 18-70 years of age

Hepatically impaired patients:

* Adult patients, 18-65 years of age
* Documented chronic stable mild/moderate/severe liver disease (Child-Pugh class A, B or C)
* Hepatic impairment should be primary and must not be a complication of an underlying primary disease

Exclusion Criteria:

General:

* Pregnant or lactating women
* Suspicion of drug abuse or addiction at time of screening/Day -1 or history of drug abuse in the last month (patients) or last year (healthy volunteers) prior to Day -1
* Confirmed significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator
* Positive for HIV infection
* Renal insufficiency

Healthy volunteers:

* History of significant disease, or evidence of disease or condition which could interfere with the study or relapse during or immediately after the study
* Any history of depressive episodes or treatment with antidepressants
* Alcohol consumption averaging more than 2 units (16 g) of alcohol for females or 3 units (24 g) for males per day, or positive alcohol breath test at screening/Day -1
* Positive for hepatitis B and/or hepatitis C infection

Hepatically impaired patients:

* Evidence of unstable clinically significant disease other than impaired hepatic function, or condition or disease which could interfere with the study or relapse during or immediately after the study
* Episode of acute depression within the last 6 months or current or previous (within the last 6 months) antidepressant treatment
* Hepatocellular carcinoma or acute hepatic disease caused by infection or drug toxicity
* Presence of surgically created or transjugular intrahepatic portal systemic shunts
* Biliary liver cirrhosis or other causes of hepatic impairment not related to parenchyma disorder and/or disease of the liver
Diagnosis and Treatment Planning in Patients Suspected of Having Lung Cancer

RATIONALE: Diagnostic procedures and treatment-planning systems may affect outcome in patients suspected of having lung cancer.

PURPOSE: Randomized diagnostic trial to compare the effectiveness of two types of diagnostic and treatment-planning systems in patients who are suspected of having lung cancer.

OBJECTIVES: I. Compare the survival rate of patients with suspected lung cancer when diagnosed and managed using the conventional locally based approach versus a new centralized system using a 2 stop diagnosis. II. Compare the resection rate in both diagnostic arms. III. Assess the quality of service given in both diagnostic arms.

OUTLINE: This is a randomized study. Patients present to a general practitioner where they are referred to the local chest clinic. Patients are seen by the chest physician and, if deemed eligible, are randomized between 2 diagnostic arms. Arm I (Conventional Locally Based Diagnosis): Patients undergo bronchoscopy and CT scan as appropriate, and then are discussed or referred by individual chest physicians, as is the current practice. The optimal period for diagnosis and discussion of management plans is 6 weeks. Arm II (Centralized 2 Stop Diagnosis): Patients undergo CT scan the following Monday morning. The consultant radiologist advises the most appropriate diagnostic test (e.g., bronchoscopy or percutaneous needle biopsy) to be done that same Monday. A tissue diagnosis is available Thursday morning for the multidisciplinary meeting attended by the chest physician, medical and clinical oncologists, and a surgeon, and the patient treatment plan is decided. Quality of life is assessed at baseline and at 6 weeks. Patients are followed for 2 years.

PROJECTED ACCRUAL: A total of 252-315 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Possible diagnosis of lung cancer Fit enough for bronchoscopy and CT scan

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Not specified
Impact of Stigma in Siblings of Young Patients With Schizophrenic Disorders

Impact of stigma on the empathy and quality of life of people with schizophrenic disorders and their siblings.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for the Person with Schizophrenic Disorder

1. Aged between 18 and 35.
2. Medical follow-up in progress
3. DSM-5 diagnosis of Schizophrenia Spectrum Disorder
4. Reading and understanding the information and non-opposition form
5. Person affiliated to a social protection scheme or beneficiary of State Medical Aid
6. Volunteer mastering the French language

Exclusion Criteria:

Non-inclusion criteria for the person with schizophrenic disorders:

1. Clinical condition incompatible with testing 2. Current or less than one month's commitment to another research protocol 3. A person who is subject to a safeguard measure of justice 4 A person of full age under guardianship 5. Minor patients with mental disorders 6. Pregnant or breastfeeding women Version 1.2 date 19-05-2020 7. A person in situations of social fragility (persons deprived of liberty by a judicial or administrative decision, hospitalized persons) 8. Persons incapable or unable to give consent

Inclusion Criteria:

Inclusion criteria for a sibling member:

1. Age of 16 years or older
2. Volunteer with a sibling included in the study with a diagnosis of schizophrenia according to DSM-5.
3. Reading and understanding the information and non-opposition form
4. Volunteer affiliated to a social protection scheme or beneficiary of State Medical Aid
5. Volunteer mastering the French language

Criteria for non-inclusion of siblings:

1. Clinical condition incompatible with testing
2. Current or less than one month's commitment to another research protocol
3. Brother or sister subject to a measure of safeguard of justice 4 Brother or sister under curatorship

5. Brother or sister with mental health problems 6. Minor siblings under 16 years of age 7. A pregnant or nursing sister 8. Brother or sister in situations of social fragility (Persons deprived of liberty by a judicial or administrative decision, hospitalized persons) 9.Brother or sister incapable or unable to give consent
Comparison of the Laryngeal Mask Ambu Aura-i Versus AirQ in Children

The investigators will evaluate the first attempt visualized blind intubation through an Ambu Aura-i versus an AirQ.

After induction of anesthesia, one of the 2 laryngeal masks (Ambu or AirQ) is going to be inserted. Following this, a tracheal tube is mounted on a fiberoptic scope with the tip of the scope behind the tip of the tube. This way, the tracheal tube is not guided by the scope, but the scope visualizes the course of the tracheal tube in the laryngeal mask and the glottic opening as if the tracheal tube was advanced blindly: Visualized blind intubation

Eligibility Criteria:
Inclusion Criteria:

* 0-16 years
* max 50kg
* ASA I-III

Exclusion Criteria:

* risk of aspiration
* known difficult airway
* congenital malformations respiratory tract
Validity and Reliability of a Danish Version of the Banff Patella Instability Instrument (BPII 2.0-DK)

The Banff Patella Instability Instrument (BPII 2.0) is a disease-specific quality of life questionnaire designed to assess adults with patellar dislocations.

As the BPII 2.0 already is cross-cultural translate and adapted to Danish the examination of the the psychometric properties of the Danish version is still needed

The aim om this study is to determine validity and reliability of the Danish version BPII 2.0-DK in a Danish populations of patients with patellar dislocation.


Eligibility Criteria:
Inclusion Criteria:

* Danish Speaking
* Patella instability problems

Exclusion Criteria:

* None
A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of R348 eye drops in patients with dry eye disease.

This is a randomized, double-blind, placebo-controlled single and multiple ascending dose study to evaluate the ocular tolerability, safety, and pharmacokinetics of R348 administered in patients with mild to moderate keratoconjunctivitis sicca (KCS).

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate Keratoconjunctivitis Sicca.
* A corrected visual acuity in both eyes of 20/40 or better.
* An intraocular pressure of \< 21 mm Hg with a difference between eyes of \< 6 mm Hg.

Exclusion Criteria:

* History or evidence of ocular infection, inflammation, or conjunctivitis within 2 months prior to the first dosing day.
* History or evidence of blepharitis requiring the use of antibiotics or eye scrubs within 2 months prior to the first dosing day.
* History of herpes simplex keratitis at any time.
* Current ocular allergy symptoms.
* Recent use of eye medications such as steroids or cyclosporine
* Refractive eye surgery within 12 months of the first dosing day.
* Other eye surgeries within 4 months of the first dosing day.
* Current use of contact lenses or discontinuation of contact lens use within 2 weeks of the first dosing day.
* Receipt of any blood or blood products within 90 days prior to the first dosing day.
* Participation in any clinical study within 30 days prior to the first dosing day.
* History of disease, or currently have a significant illness or abnormal laboratory finding as determined by your study doctor.
* Positive for hepatitis B, hepatitis C or HIV.
* Smoked regularly within 12 months of first dosing day.
* History of substance abuse, drug addiction or alcoholism.