cyrilzakka/clinical-trials huggingface dataset:
Acceptability and Feasibility of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users and Vulnerable Populations, in Non-conventional Structures "Outside the Walls" by Dual Screening Method RTDs and FibroScan®

The "Scanvir" concept aims to achieve barriers to HCV screening and treating of marginalized patients. The concept is applicable to other various populations and territories and should effectively improve HCV patient's health outcomes. The main objective of the SCANVIR project was to evaluate the feasibility, acceptability and reproducibility of a "test, treat and cure" strategy for PWIDs and vulnerable populations during dedicated days in addiction care centers.

According to the French recommendations, eliminating hepatitis C virus by 2025 could be a realistic public health goal in this country. A total of 71,466 patients had treatment initiation between 2015 and 2019. It is estimated that 100 000 people are still infected in 2019.

To meet these ambitious objectives, effective screening policies should be intensified and access to treatment promoted through new care strategies for patients who escape the usual care pathways i.e. people who inject drugs (PWIDs), prisoners, migrants and vulnerable populations.

PWIDs represent a large proportion of patients to be screened and treated. It's still not possible to accurately evaluate the number of drug users who are infected with HCV (45 000 people estimated).

Drug users sharing needles and syringes have poor access to treatment. Dealing with PWIDs in addiction care centers (CSAPA and CAARUD in France) is one way to promote HCV testing, and to keep them in the care pathway. This population requires dedicated models that reduce barriers to care: harm reductions policies, access to therapy in real time and follow-up for the detection of reinfection. So the investigator designed and applied a new innovative concept to test, treat and cure PWIDs in their own environment, called the SCANVIR program, initially tested in four French departments with a regional and now national extension.

Eligibility Criteria:
Inclusion Criteria:

* Adult 18 and over
* Patient frequenting an unconventional structure "outside the walls" or referred by a professional in the care sector
* Patient not opposed to research

Exclusion Criteria:

* Age under 18
* Patient opposed to research
Comparison of De-Epithelialized Gingival Graft With or Without Platelet Rich Fibrin in Multiple Gingival Recessions

The aim of this study is to compare the clinical efficacy and patient reported outcome measures of de-epithelialized gingival graft (DGG) with or without platelet rich fibrin on treatment of multiple adjacent gingival recessions with coronally advanced flap (CAF) technique.

Fifteen patients with split-mouth multiple gingival recessions affecting at least 3 adjacent teeth will be treated with either DGG or DGG+PRF. Recession depth(RD) and width(RW), probing depth(PD), clinical attachment level(CAL), keratinized tissue width (KTW), gingival thickness(GT), and percentage of root coverage (RC%) will be evaluated at 1, 3 and 6 months postoperatively. For patient reported outcome measurements, oral health impact factor-14 (OHIP-14) scores, postoperative pain, bleeding, discomfort and painkiller consumption will be recorded.

A total of 15 patients will surgically treated with coronally advanced flap (CAF) associated with de-epithelialized gingival graft. Groups were defined as DGG and DGG+PRF:

DGG Group (n=15): de-epithelialized subepithelial connective tissue grafts + coronally advanced flap DGG+PRF Group (n=15): de-epithelialized subepithelial connective tissue grafts+ L-Platelet Rich Fibrin + Coronally advanced flap

Eligibility Criteria:
Inclusion criteria of participants were as belows:

Age \> 18 years Systemically healthy and non-smoker Full-mouth plaque index and full-mouth gingival index score\< 20% No mucogingival surgery experience at operation area No active periodontal disease Patients who have not received orthodontic treatment

Exclusion criteria of participants were as belows:

Pregnancy and lactation Bruxism or occlusal trauma Medical contradictions and for periodontal plastic surgery (i.e. mental disorders) Medication intake

Inclusion criteria of surgical area were as below; Presence of at least three single-rooted teeth (anterior-premolar) with RT1 Class \[25\] buccal gingival recession defects ≥2 mm in depth Keratinized gingival width\<3 mm Sufficient oral hygiene (bleeding on probing \<10%, Periodontal Depth\<3 mm) Patients without restoration and/or filling in the gingival recession area Absence of non-carious cervical lesions and non-detectable cemento-enamel junction (CEJ) at the defect sites
Rituximab, Cyclophosphamide, Vincristine and Prednisone (R-CHOP) Plus Metformin in Diffuse Large-B-cell Lymphoma

Evaluation of the safety and effectiveness of metformin as an adjunct to RCHOP chemotherapy for patients with newly diagnosed diffuse large-B cell lymphoma

Patients with newly diagnosed diffuse large-B cell non Hodgkin lymphoma, irrespective of cell of origin status will receive metformin in combination to Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (RCHOP) chemotherapy for 6 cycles, until response evaluation as reported elsewhere:

1.- Rituximab 375 mg/m2 IV, day 1. 2.- Cyclophosphamide 750 mg/m2 IV, day 1. 3.- Doxorubicin 50 mg/m2 IV day 1. 4.- Vincristine 1.4 mg/m2 IV (2 mg maximum dose). 5.- Prednisone 60 mg/m2 PO days 1-5. Six cycles every 21 days.

Metformin will be added and administered in an outpatient basis, starting with 425 mg twice a day for 1 week, followed by 850 mg twice a day for 1 week, and lastly 850 mg every 8 hours maximum dose until re-staging. Laboratory tests will be performed serially.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed nodal diffuse large-B cell non Hodgkin lymphoma according to the 2008 World Health Organization classification for lymphoid malignancies
* No previous treatment other than prednisone or equivalent glucocorticoid up to 60 mg/m2 for 14 days
* Good performance status (Eastern Cooperative Oncology Group scale 0-2)
* Life expectancy \>6 months
* Independently of the diagnosis of diabetes mellitus (any type)

Exclusion Criteria:

* History of intolerance or hypersensitivity reactions to metformin
* Primary central nervous system lymphoma
* History of other previous malignant neoplastic diseases \<5 years prior to enrollment
* Evidence of systemic infection at the time of study
* HIV, hepatitis C or B virus infection
* Aspartate transaminase or alanine transaminase \>2x upper limit of normal, bilirubin \>2.5 times upper limit of normal
* Serum creatinine \>1.5 mg/dL or chronic renal disease
* Cardiac insufficiency (New York Heart Association scale \>1 or ejection fraction \<50%)
* History of transformation from an indolent lymphoma
* Pregnancy
* History of lactic acidosis or alcoholism
Effects of Meditation on Sleep Quality of Medical Students

The objective of the study is to evaluate the effect of an 8-week online mindfulness-based meditation program on quality sleep status of undergraduate students medicine in the city of Passo Fundo/RS and Chapecó/SC In addition to sleep quality, secondary outcomes such as mindfulness, symptoms of depression, stress, anxiety and burnout will also be assessed

A controlled, single-center, randomized parallel group clinical trial will be developed to evaluate the effectiveness of an online mindfulness-based meditation program (POMBM) on the quality of sleep of medical students. The trial expects to involve 136 participants who will be randomized 1:1 into the intervention group or a waiting group (which will be called the control group), with 68 expected participants each. All trial procedures will take place online via Google meet and will consist of an invitation and presentation of the study, followed by an initial screening visit for those interested, and an intervention period of 8 weeks. The POMBM will be administered weekly online during the intervention period, with each session lasting 45 to 60 minutes. The control group will not perform any activities during the intervention period. Participants in both groups will be evaluated at the initial visit (T0), in the fifth week (T1), immediately after the end of the intervention period (T2) and in a 2-month follow-up after the end of the program (T3) using the following instruments : PSQI (Pittsburgh Quality Sleep Index), ESE (Epworth Sleepiness Scale), MAAS (Mindful Attention Awareness Scale), DASS-21 (Depression, Anxiety and Stress Scale), and CBI-S (Copenhagen Burnout Inventory Student Version)

Eligibility Criteria:
Inclusion Criteria:

* Interest in participating in the study; over 18 years old; both genders; being duly registered in the Medicine course at Passo Fundo or Chapecó's faculties, from the 1st to 12th phase of the course

Exclusion Criteria:

* Have participated in another course or workshop on meditation in the last 4 weeks in addition to the invitation to study; being an active practitioner of meditation, yoga, tai-chi, qui-gong (at least 6 months before the start of the study); previous medical diagnosis of cognitive, language or communication deficits; alcohol dependence and other chemical substances; previous medical diagnosis of a disorder with risk of suicide or attempt of previous suicide; previous medical diagnosis of post-traumatic stress disorder; previous medical diagnosis of depressive disorder currently untreated; previous medical diagnosis of schizophrenia or delusional/hallucinatory disorders; previous medical diagnosis of social anxiety (difficulty being in a classroom)
Exercise Prehabilitation in Patients With Head and Neck Squamous-cell Carcinoma: The FIT4TREAT Trial

The main purpose of this randomized-controlled trial is to evaluate the effects of prehabilitation based on exercise training (ET) on functional capacity in HNC patients treated with chemoradiotherapy (CRT). Forty-six participants will be randomized (1:1 ratio) into prehabilitation and usual care groups. The length of intervention will be at least 2 weeks. Data will be collected at diagnosis, immediately before anti-cancer treatment start and 4 weeks following CRT. Primary outcome is functional capacity as assessed by the six-minute walk test. Additional measures include muscle strength, endothelial function, arterial stiffness, inflammatory biomarkers, body composition, quality of life, treatment tolerance, compliance to treatment, progression-free survival, and overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old;
* Histologically confirmed HNSCC located on the oral cavity, larynx, oropharynx, hypopharynx, nasopharynx or in lymph nodes from an unknown primary tumor (stage I-IV);
* Proposed for concomitant chemoradiotherapy with curative intent;
* Date of treatment beginning ≥2 weeks from baseline assessment;
* ECOG-Performance Status 0-1.

Exclusion Criteria:

* Completion of previous anticancer treatment within less than a year;
* Uncontrolled hypertension, cardiac or pulmonary disease;
* Contraindications to exercise training;
* Inability to provide informed consent;
* Expected inability to fulfil the proposed schedule.
Sex Hormones and Pericardial Adipose Tissue

In this study, our aim is to show the relation between sex hormones and PAT and to confirm whether PAT is associated with coronary artery calcification (CAC) in different testosterone levels in the males.


Eligibility Criteria:
Inclusion Criteria:

* 3213 males
* African American
* Caucasian
* Asian (largely Chinese) and Hispanic adults aged 45-84 years and free of known cardiovascular disease at baseline (2000-2002)

Exclusion Criteria:

* Patients with known coronary artery disease
A Study of Trabectedin in Patients With Advanced Ovarian Cancer

The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced ovarian cancer.

Patients will be enrolled in the study after all study-specific entry criteria are met and informed consent is obtained. Patients will be required to attend regular clinic visits to receive study medication and have their status monitored. Patients will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the study physician (Investigator) conducting this study. Trabectedin at a starting dose of 0.58 mg/m2 will be given to patients intravenously (i.v). as a 3-hour infusion every week for 3 weeks (on Days 1, 8, and 15) of a 4 week cycle via a central venous catheter (also referred to as a "central line" which is a tube ie, "catheter" placed into a large vein). All patients will receive dexamethasone 10 mg i.v. 30 minutes prior to each trabectedin infusion. Patients may receive multiple cycles of trabectedin in the absence of disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced epithelial ovarian cancer
* Progression or recurrence during or after platinum-containing regimen
* At least one measureable tumor lesion
* Adequate bone marrow, hepatic and renal function
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

* Known hypersensitivity to any components of the i.v. formulation of trabectedin or dexamethasone
* Pregnant or lactating women
* Known metastases (spread) of cancer to the central nervous system
* History of another neoplastic disease unless in remission for five years or more.
Evaluate The Safety, Tolerability and Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers

This is a Phase 1, randomized, double-blind, single center, placebo-controlled, sequential cohort study in a maximum of 3 cohorts of 10 healthy male and/or female subjects each. Subjects in Cohorts 1, 2 and 3 will receive ascending multiple oral doses of WCK 4873 or matching placebo once daily on Days 1 to 7. Dosing will be conducted under fed conditions on each dosing day. The dose levels to be administered will be based on the safety, tolerability and PK results of the single dose and food effect study (W 4873 01 study; PRA-code WOE384EC-123841).


Eligibility Criteria:
Inclusion Criteria:

* BMI : 18.0-30.0 kg/m2 (Body Mass Index \[BMI\] \[kg/m2\] = Body weight \[kg\] Height2 \[m2\])
* Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "power-drinks"), grapefruit (juice) from 48 h prior to entry in the clinical research center until discharge
* Medical history without major pathology as judged by the Principal Investigator
* Resting supine blood pressure 90-139 (systolic) / 40-89 (diastolic) mmHg, a resting pulse rate of 40 beats per minute or higher, and showing no clinically relevant deviations as judged by the Principal Investigator
* Computerized 12-lead electrocardiogram (ECG) recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Principal -Investigator. QTcF should be \<450 ms

Exclusion Criteria:

* Previous participation in the current study
* Evidence of clinically relevant pathology
* Mental handicap
* History of Myasthenia Gravis
* History of hepatitis and/or jaundice associated with the use of any antibiotic
* Congenital prolongation of the QTc interval, ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia
* History of relevant drug and/or food allergies
* Regular/routine treatment with non-topical medications within 30 days prior to entry into the clinical research center
* Smoking within 60 days prior to drug administration and through the follow-up visit
* History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
Time Interval for Endoscopic Variceal Ligation

Patients with liver disease frequently present to the hospital with bleeding from dilated veins in their foodpipe (called esophageal varices). The current standard of care is to perform endoscopic variceal ligation (placing rubber bands around the varices through an endoscope)in patients presenting with bleeding varices. Patients generally receive ligation at the time they come in with bleeding and then return at regular intervals to have repeat ligation in order to eradicate the varices. However there have been no studies to determine the appropriate intervals for esophageal variceal ligation until eradication. We will conduct a randomized comparison of 1-week vs. 2-week intervals for esophageal ligation in patients that have presented with bleeding varices. Our hypothesis is that one-week ligation will achieve more rapid eradication than the two-week interval with a greater proportion of patients achieving variceal eradication at 4 weeks after the index bleeding episode.


Eligibility Criteria:
Inclusion Criteria:

* Patients who presented with acute upper GI bleeding due to esophageal varices and underwent successful endoscopic variceal ligation.
* Patients who would normally receive repeat endoscopic ligation therapy to eradicate varices.

Exclusion Criteria:

* Persistent bleeding despite endoscopic and medical therapy
* Platelet count \< 40,000
Randomized Controlled Trial of Early Intensive Leg Exercise to Improve Walking in Children With Diplegia

This is a randomized controlled trial, comparing 3 months of intensive leg exercise to standard physiotherapy care for the improvement of gross motor function in young children with spastic diplegia.

Children born prematurely are at risk of brain injury that can result in cerebral palsy, most often affecting both legs. Current treatment is largely passive, including leg braces, repeated injection of a paralyzing agent (botulinum toxin) in muscles that are abnormally active, and surgery as deformities occur. Active, physical therapy for weak muscles is infrequent, occurring twice a month or less. Yet, recent work in mammals show that early brain injury can be alleviated by intensive exercise therapy, but only while the animal is very young.

Building on our success with early, intensive therapy for children with perinatal stroke, we will apply intensive therapy for the legs in children with cerebral palsy involving both legs. Children (8 mo - 3 yr old) will be randomly assigned to start treatment immediately or delay treatment for 6 months. The delay period controls for improvement without treatment. The children in the Delay Group will have the option to receive the same treatment after the delay period. The therapy will be guided by physical therapists, and centered on play. Measures will be taken before, during and after the delay and treatment periods. Measures will include clinical scores of motor development, proficiency of walking, participation at home, and physiological measures of motor and sensory function. All children will be followed until they turn 4 yr old, to determine if there are long term benefits. The cost-effectiveness of the intervention will be evaluated by a health economist. We anticipate that early intensive exercise will improve mobility, facilitate earlier and better walking, and that the effects will be enduring.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral motor impairment of the lower extremities
* Periventricular white matter injury from encephalopathy of prematurity
* Able to stand with some support

Exclusion Criteria:

* Substantial upper extremity involvement - Manual Abilities Classification System (MACS) Level ≥3
* Uncontrolled epilepsy or infantile spasms in the past 6 months
* Cardiovascular or musculoskeletal complications that preclude participation in intensive exercise
* Botulinum toxin-A (BTX-A) injections in the legs in the last 6 months
An Evaluation of the Memory at Work Program

With the aging of the Canadian population, older workers are accounting for more and more of the working-age population. Despite recent interest in cognitive training, there are currently no validated programs that specifically target individuals in the work force. The investigators will conduct a small-scale randomized controlled trial to test the effectiveness of the previously developed Memory at Work program. The investigators will recruit 60 individuals and randomly assign them to the active intervention or a control intervention. The investigators will examine outcomes related to knowledge, behavioral change, self-efficacy, objective memory, and workplace productivity. The investigators expect larger improvements on these measures in the active relative to the control group.

This is a pre-test/post-test randomized controlled trial. Participants who meet eligibility criteria will undergo baseline testing that involves completing questionnaires and objective cognitive tests. Participants will then be randomly assigned (by coin toss) to the intervention or control group. After participating in their respective workshops, both groups will undergo immediate post-testing and 1-month follow-up post testing. After the final assessment, the control group will be given the opportunity to participate in the intervention workshop. No further testing of this group will occur, as there will no longer be a comparable control group.

Eligibility Criteria:
Inclusion Criteria:

* Currently employed
* Between ages 30-65
* Fluent in English language

Exclusion Criteria:

* A severe head injury, epilepsy or other neurological disorder
* Currently unemployed
* Evidence of significant psychiatric disorder/use of psychotropic medications
* Evidence of substance abuse
Lipid-lowering Effect of Plant Stanol Yogurt

To determine the effect of investigational products on serum LDL cholesterol.

Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient administered in a yogurt is less well known.

Study was monitored by Foodfiles

Eligibility Criteria:
Inclusion Criteria:

* subjects must voluntarily sign the informed consent
* subjects must be male or female aged 20 to 70 years
* subjects must have a serum total cholesterol concentration of 5.2 - 7.5 mmol/l ( 205 - 290 mg/dl) at the screening visit (visit 1, -2 week)

Exclusion Criteria:

* subjects using lipid lowering medication
* subjects using ezetimibe
* subjects with bile acid sequestrant medication
* subjects with statin therapy
* subjects using other medication significantly influencing on lipid values
* subjects with diagnosis type 1 or type 2 diabetes
* severe obesity (BMI\>35.0 kg/m2)
* serum fasting triglycerides \> 4.0 mmol/l
* subjects with any hepatic or renal disorder according to medical history
* subjects who have history of myocardial infarction or unstable angina pectoris within six months prior to screening
* subjects who have history of coronary artery bypass graft or percutaneous transluminal coronary angioplasty within six months prior to screening
* subjects who have history of temporal ischemic attack or stroke within six months prior to screening
* subjects who have a history of cancer or other malignant disease within the past five years
* subjects with abnormal values of health screening variables measured at screening visit: serum gamma-glutamyltransferase\> 2 x upper limit, serum alkaline phosphatase\> 2 x upper limit or other abnormality in laboratory evaluations considered as clinically significant in the opinion of the study physician
* subjects who are consuming more than 15 portions of alcohol / week
* subjects who are pregnant or lactating
* subjects using Benecol, Becelpro.activ, Danacol or other plant sterol enriched products within 30 days before visit 2
* subjects with severe lactose intolerance, milk allergy or any other intolerance to the ingredients of test products
* celiac disease