cyrilzakka/clinical-trials huggingface dataset:
Evaluating Astaxanthin Bioavailability, and a New Technology for Improving it, Using Natural Food Materials Only

The purpose of this study was to develop a potato protein (PP)-based delivery system for increasing oral bioavailability of lipophilic bioactives (nutraceuticals and drugs), using astxanthin (AX) as a model, and to evaluate the system in vivo in a crossover clinical study in human volunteers. Three different formulations were prepared, encapsulating AX oleoresin (AXO) with (1) PP only, (2) PP+lecithin (LEC), and (3) PP+olive oil (OO). In a randomized, double-blind, crossover study in human subjects, the PP-OO-AX formulation had a 4.8-fold higher median plasma AX area under the concentration-over time curve (AUC; P\<0.001) compared to the raw AXO formulation.

In conclusion, a non-allergenic, vegan, PP based delivery system made of "all-natural ingredients" offers a great promise for increasing oral bioavailability of lipophilic bioactives such as AX, for the enrichment of food and for dietary supplements, or oral delivery of lipophilic drugs.

Astaxanthin (AX) is a red xanthophyll carotenoid found mainly in algae (notably Haematococcus Pluvialis microalga) and marine animals. AX is a stronger antioxidant than vitamin E and β-carotene but has very low oral bioavailability. The purpose of this study was to develop a potato protein (PP)-based delivery system for increasing oral bioavailability of lipophilic bioactives (nutraceuticals and drugs), using AX as a model, and to evaluate the system in vitro and in vivo in a crossover clinical study in human volunteers. Three different formulations were prepared, encapsulating AX oleoresin (AXO) with (1) PP only, (2) PP+lecithin (LEC), and (3) PP+olive oil (OO). The average particle diameters after preparation were 0.29, 0.29, and 1.76 μm, and after freeze-drying and reconstitution 0.17, 0.07, and 6.93 μm, respectively. In vitro bioaccessibility was 33, 47, and 69%, respectively, versus 16% only for the raw AXO. In a randomized, double-blind, crossover study in human subjects, the PP-OO-AX formulation had a 4.8-fold higher median plasma AX area under the concentration-over time curve (AUC; P\<0.001) compared to the raw AXO formulation. In conclusion, a non-allergenic, vegan, PP based delivery system made of "all-natural ingredients" offers a great promise for increasing oral bioavailability of lipophilic bioactives such as AX, for the enrichment of food and for dietary supplements, or oral delivery of lipophilic drugs.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Aged 18 - 26
* Normal physical examination
* Normal electrocardiogram (E.C.G.)
* Normal laboratory profile

Exclusion Criteria:

* Any active medical illness (e.g. liver disease, kidney disease, or diabetes, intestinal malabsorption, hypercalcemia)
* Lactose intolerance
* Food allergies
* Excessive alcohol use (over 40 ml/day)
* Pregnant or breast-feeding
* Hyperlipidemia (LDL\>130, triglycerides\>200)
* Regular medication use
* Obesity (BMI\>30 kg/m2)
* Use of multivitamins, or carotenoid supplements during the past month prior to the study
* Current smoking
Zinc Supplements in Lowering Cadmium Levels in Smokers

RATIONALE: Zinc supplements may lower cadmium levels in smokers and may help prevent DNA damage.

PURPOSE: This clinical trial is studying how well zinc supplements work in lowering cadmium levels in smokers.

OBJECTIVES:

* Determine whether zinc supplements reduce cadmium levels in smokers.
* Measure serum levels of cotinine (a biomarker of smoking), zinc (a marker of compliance), and cadmium (the dependent variable) at 3 pre-supplementation visits and at 6 supplementation visits.
* Determine whether serum cadmium levels (adjusted for serum levels of cotinine) decrease during supplementation with VisiVite Smoker's Formula.
* Determine if increased cadmium levels in the blood of cigarette smokers can be correlated with decreased mismatch repair.
* Determine if administration of zinc-containing supplements reverses cadmium-induced inhibition of mismatch repair.

OUTLINE: This is an open-label, nonrandomized study.

Patients receive oral zinc supplements once daily for 12 weeks in the absence of unacceptable toxicity.

Blood, serum, and urine are collected once weekly for 3 weeks before beginning treatment and in weeks 5, 6, 9, 12, 15, and 17 for biomarker/laboratory analysis. Samples are examined for cadmium, zinc, and cotinine levels by atomic absorption spectrophotometry, expression of mismatch repair proteins (MSH2, MSH6, MSH3, MLH1, and PMS2), levels of messenger RNA by reverse transcriptase-polymerase chain reaction, and microsatellite instability by gel electrophoresis.

After completion of study therapy, patients are followed for 5 weeks.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Currently smoking ≥ 1 pack (20 cigarettes) per day
* Baseline cadmium level ≥ 0.5 μg/L

PATIENT CHARACTERISTICS:

* Negative pregnancy test
* Fertile patients must use effective contraception
* No known gastrointestinal upset due to zinc vitamins or lozenges

PRIOR CONCURRENT THERAPY:

* At least 2 weeks since prior and no other concurrent vitamins and zinc supplements
Breech External Cephalic Version Intervention Trial

A prospective study assessing the use of external cephalic version for the management of breech presentation in pregnancy.

The primary aim of the study is to determine the success rate of external cephalic version for breech presentation from 36 gestational weeks.

Eligibility Criteria:
Inclusion Criteria:

* Presence of the written consent of the patients.
* The patients must be over 18 years old .
* No limit in the ability to consent.

Exclusion criteria:

* Age under 18
* Limited ability to consent
* Placenta previa
* Fetal abnormalities
Caregiver Burden in Huntington's Disease

Huntington's disease (HD) is a rare inherited neurodegenerative disorder, progressing between 15 and 20 years and affecting one person out of 10.000. In France, it concerns some 6.000 patients symptomatic and 12 000 asymptomatic carriers.

Few extensive researches have been conducted on the progression of the disease, which is defined in the literature in 5 stages in a functional approach.

Therapeutically, no cure for HD is currently validated but only symptomatic treatments. There's various treatment options: medicated, humans (physiotherapy, speech therapist, occupational therapist, ..).

Although these treatment options do not prevent the progression of the disease, their combination associated with a stimulating environment may slow the decline of physical, intellectual and psychic abilities of patients.

In social terms, patients with HD require sustained support, especially in cases of family isolation.

The behavioural, gaiting and eating disorder as well as the communications difficulties make it difficult support daily for the entourage. The caregivers are sometimes dealing with untenable situations. Home care services, which are crucial to alleviating dependency, relieve family caregivers but are for the most severe patient.

Moreover, the justified placement decision in an institution generates a feeling of guilt for the family.

The caregiver is the person who brings non-professional assistance , partly or wholly , to a dependent member of his entourage , for the activities of daily living. This regular care may be provided permanently or not. It can take many forms, such as , care , nursing , support to education and social life , administrative procedures , psychological support .

Caregivers have their lives profoundly reshaped. They are often forced to give up some of their habits , give up their future plans , change their relationships. The commitment of caregivers with patients with Huntington's disease actually sounds on their mental and physical health, as well as their social and professional life

Very few studies have been conducted to measure the difficulties and implications of these caregivers.


Eligibility Criteria:
Inclusion Criteria

* Age ≥ 18
* Primary caregiver of patient with Huntington's disease
* Non- institutionalized Patient
* stage 1-4 (no institutionalization within 2 years)
* written consent

Exclusion Criteria

- Not agreement
Mobile Phone App for Depression and Anxiety in Young Men Who Are Attracted to Men

The purpose of this study is to determine whether a mobile phone application ("app") for symptoms of depression and anxiety is practical and acceptable to young men who are attracted to men, and whether it reduces their anxiety and depressive symptoms. The investigators will also evaluate whether reductions in symptoms are maintained over a 10 week follow-up period after young men complete the mobile phone intervention.

The aim of this study is to conduct a small randomized controlled trial (RCT) for a 10-week, culturally tailored mobile phone intervention that uses principles of cognitive behavioral therapy (CBT) to reduce anxiety and depression among young men who are sexually attracted to other males.

The primary purpose of the RCT is to collect feedback about the intervention from the participants. This feedback, along with usage data on which features are used more or less often by the participants, and how the features are used, will be evaluated to make improvements to the intervention. The investigators will also assess clinical outcomes (such as anxiety and depressive symptoms). Outcomes will be monitored pre-, mid-, and post-treatment, as well as twice over a 10 week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Male birth sex and male gender identity
* Reports sexual attraction toward males
* Is between 17-20 years of age
* Is able to speak and read English
* Resides in the Chicago metropolitan area (i.e., Chicago or suburbs of Cook County)
* Currently owns a mobile phone that is compatible with the intervention application, and believes he will be able to keep using this mobile phone for the next 10 weeks
* A score of 10 or more on the Patient Health Questionnaire-9 or 5 or more on the GAD-7

Exclusion Criteria:

* Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of the Internet or mobile phone
* Per self-reported history or the Mini-International Neuropsychiatric Interview, has ever been diagnosed with a psychotic disorder or bipolar disorder, or is currently diagnosed with obsessive compulsive disorder or substance dependence, or has been diagnosed in the past five years with posttraumatic stress disorder, dissociative disorder, or eating disorder; or evidences another condition that indicates this intervention may be insufficient
* Has ever been hospitalized for psychiatric reasons or attempted suicide, or has a score of 4 or more on the Columbia Suicide Severity Rating Scale, or reports non-suicidal self-injury of a nature that suggests this intervention may be insufficient
* Is participating in "Crew 450," "Keep It Up," "My Peeps," or "Q2"
* Reports currently being in Illinois Department of Child and Family Services (DCFS) custody
* Reports currently being in psychotherapy
* Initiation, discontinuation, or adjustment of antidepressant medication in the past 4 weeks
* Less than an 8th grade reading level
* Does not log into the app within 3 days of being sent the link.
* Does not have an email address
Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy

This is a prospective, multicenter, randomized study to evaluate the clinical performance of a novel CADe device, WISE VISION® Endoscopy System, in patients undergoing high-definition white light (HDWL) colonoscopy for screening or surveillance of colorectal Cancer (CRC).

Eligible subjects who meet the study inclusion/exclusion criteria will be randomized in a 1:1 ratio to undergo colonoscopy :

* Experimental: CADe colonoscopy procedure with WISE VISION® Endoscopy (CADe Group)
* Control: Standard Colonoscopy without CADe (Standard Colonoscopy Group)

This study aims to evaluate whether NEC WISE VISION® Endoscopy enhances the ability to detect mucosal lesions when compared with the current standard-of-care procedure (high-definition white light \[HDWL\] colonoscopy). The CADe device, Wise VISION® Endoscopy, contains an artificial intelligence/machine learning (AI/ML) advanced algorithm to aid the endoscopists in detection of colonic lesions.

This study plans to enrol 830 subjects aged ≥ 45 years and \< 75 years, who are scheduled for screening or surveillance colonoscopy.

After review of the inclusion and exclusion criteria, eligible subjects will be randomized in a 1:1 ratio to receive either computer-aided colonoscopy (CADe Group) or standard colonoscopy without CADe (Standard Colonoscopy Group).

All adenomas, that are identified during the colonoscopies, will be removed and biopsied as per standard clinical practice to assess adenoma miss rate, polyp miss rate, adenomas per colonoscopy and other endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Patient is presenting to the endoscopy unit for colon cancer screening or surveillance colonoscopy.
* Signed Informed Consent

Exclusion Criteria:

1. Contraindications to colonoscopy
2. Colonoscopy within the previous three (3) years
3. High-risk indications for colonoscopy
4. Antithrombotic therapy that cannot be stopped, precluding polyp resection
5. Inflammatory bowel disease
6. Referred for endoscopic mucosal resection (EMR)
7. Familial adenomatous polyposis syndrome or Serrated Polyposis Syndrome
8. Pregnant or planning a pregnancy during the study period
Multimodal Quantified Analysis of Facial Movements: Comparison Between Pathological and Control Subjects

The facial palsy is a frequent disease with a lot of etiologies. It has variable severities with sometimes heavy functional repercussions and different recovery potentials. The proposed treatments are based on surgery, physiotherapy and botulinum toxin injections. However, when recovery is incomplete, acceptance is more difficult, with an impacted quality of life. Thanks to Motion Capture and Electromyography, a quantification of the facial mimicry is now possible with a great precision. In addition with the quantification of the facial mimicry, eye-tracking, wich is widely used in the marketing field, but it also finds medical applications including head and neck lesions and facial palsy in particular, will be used to evaluate the visio of the patients on their pathology in function of the movement quantification measured with MoCap and Electromyography. The aim of this research is to measure in a combined way the action potentials by sEMG and the amplitudes of displacement of the markers in motion capture, for movements determined in a population of patients presenting a facial pathology, in order to compare them with reference values obtained in healthy subjects. In a second step, the aim will be to study if there is a link between the way the patient looks at his pathology and the results of his management (treatment, rehabilitation) which will be quantitatively evaluated thanks to MoCap and sEMG.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with no known facial pathology (healthy volunteers) OR
* Patients with peripheral facial palsy, irrespective of grade, whether or not previously treated
* Subject with written informed consent
* Subject over 18 years of age
* Subject affiliated to a social security scheme

Exclusion Criteria:

* Subjects with severe skin disorders that do not allow the application of electrodes or photo reflective markers
* Subjects with speech disorders making it impossible to pronounce the sounds \[o\] and \[pu\]
* Subject unable to provide written informed consent
* Subjects under guardianship, curators or safeguard of justice
Experiential Training for Community Therapists

The primary goal of this study is to evaluate the feasibility and acceptability of employing an experiential training approach that targets community mental health therapists' attitudes toward and use of exposure therapy. In addition to assessing attitudes and use of exposure therapy, the study will evaluate the feasibility of recruitment, randomization, retention, and assessment processes, as well as the acceptability of the experiential training relative to training-as-usual. To assess these outcomes, community therapists will be randomized to experiential training or training-as-usual. A subset of therapists from each arm will also complete qualitative interviews to further assess acceptability of the training approaches. The training-as-usual condition will include a traditional one-day workshop that focuses on principles of exposure and incorporates active learning strategies. The experiential training will include a one-day workshop that teaches principles of exposure and has therapists themselves undergo a one-session phobia treatment for spiders. Therapists in both training conditions will be asked to attend weekly consultation phone calls for a three-month period following the trainings.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be aged 21 and older with degrees (masters or doctorate) in a mental health field. They must be working in a community mental health clinic, currently treating at least one client with anxiety, and planning to continue providing therapy to at least one client with anxiety for the duration of the study. Participants must be interested in participating in a training workshop and able to commit to the time requirements for study completion. They must also be willing to provide an email or mailing address to complete study-related surveys. Finally, they must be able to read and speak English.

Exclusion Criteria:

* Participants cannot have previously attended a full day (8+ hours) workshop on exposure-based treatments for anxiety.
A Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder

The purpose of this study is to evaluate the safety and effectiveness of quetiapine in actual clinical settings.

This is a post-marketing use-result survey study required for products in Japan. The investigator will register the patient who have been taking this product for the first time within 14 days after the start of treatment (inclusive of the start day). For each of the registered patients (including withdrawals and dropouts), the investigator will enter the survey data on the case report form.

Eligibility Criteria:
Inclusion Criteria:

* Patients with depressive symptoms of bipolar disorder
* Patients who have previously not been treated with quetiapine fumarate (immediate-release formulations of quetiapine fumarate and Bipresso Extended-Release Tablets)

Exclusion Criteria:

* None
Clinical Evaluation of a New Viscoelastic for Cataract Surgery

The purpose of this study is to evaluate the safety and effectiveness of a new opthalmic viscoelastic material for the use in cataract surgery. The new viscoelastic will be compared to a currently marketed viscoelastic material.


Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy eye with no pathology other than the presence of cataract
* Visual potential of 20/40 or better

Exclusion Criteria:

* Taking any medications that affect vision, intraocular pressure or ease of cataract surgery (e.g. flomax, glaucoma medications, etc.)
* Known intraocular pressure increases from steroid treatment
* Low endothelial cell count
Interferon Alfa in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Low doses of interferon alfa may be as effective as high doses.

PURPOSE: Randomized phase III trial to compare the effectiveness of low-dose or high-dose interferon alfa in treating patients who have newly diagnosed chronic myelogenous leukemia.

OBJECTIVES: I. Compare the duration of chronic phase and survival following low- vs. high-dose interferon alfa maintenance therapy in patients with chronic myelogenous leukemia in chronic phase. II. Compare the toxicity profiles, assessed by WHO criteria, and the percentage of patients requiring dose reduction or discontinuation with these two regimens. III. Compare hematologic and cytogenetic responses every 6 months in patients treated on these two regimens.

OUTLINE: This is a randomized study. Patients receive daily hydroxyurea until their white blood cell count (WBC) is maintained at a normal level for 2-3 weeks. Patients are randomized to two groups: one group receives daily high-dose interferon alfa, and the other receives low-dose interferon alfa, 5 days per week. Both groups continue to receive hydroxyurea at reduced doses as needed to maintain a normal WBC. Treatment continues until disease progression occurs. Patients may receive cytarabine in addition to interferon in either treatment arm at the investigator's discretion. Cytarabine is given subcutaneously for 10 days every calendar month and continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for survival.

PROJECTED ACCRUAL: Approximately 800 patients will be enrolled over 8 years on this multicenter study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Chronic myelogenous leukemia in chronic phase Molecular evidence of BCR/ABL rearrangement OR Presence of Philadelphia chromosome Eligibility for allogeneic bone marrow transplantation does not exclude

PATIENT CHARACTERISTICS: Age: Adult Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Bilirubin less than twice normal No severe hepatic problem Renal: Creatinine less than twice normal No severe renal problem Cardiovascular: No severe cardiovascular problem Other: No contraindication to interferon therapy No history of severe depression No pregnant women Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: No prior therapy Prior therapeutic or back-up leukapheresis allowed Hydroxyurea may be started up to 4 weeks prior to entry
ENTRUST, a 5 Year Surveillance of Children Aged 2 to <6 Years With Transfusional Iron Overload Treated With Deferasirox

This registry will evaluate long-term safety and efficacy of deferasirox in children with transfusional iron overload.


Eligibility Criteria:
Inclusion Criteria:

* History of transfusion-dependent anemia.
* History of iron overload

Exclusion Criteria:

* Patients with non-transfusional hemosiderosis.

Other protocol-defined inclusion/exclusion criteria may apply.
Comparison Mydriasis by Mydrane With Topical Drop Application

The primary aim of the study is to compare the effectiveness of the intracameral application of Mydrane® (standardized combination of Tropicamide 0.02%, Phenylephrine 0.31% and Lidocaine 1%) with the preoperative topical application (Tropicamide 0.5% and Phenylephrine 10%). To evaluate the steadiness of the dilating effect on the pupil, the ratio of eyes without necessity for further pupil dilating procedures to perform the capsulorhexis is assessed.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between the age of 50 to 100 years
* Day-hospital and inpatient care
* Clinically significant opacity of the lens with indication for cataract surgery on both eyes
* Lack of previous ophthalmic surgeries
* Lack of relevant ophthalmic conditions: Pseudoexfoliation syndrome, eye injuries, present inflammation (in terms of uveitis, endophthalmitis and iridocyclitis), restricted mydriasis (pupil diameter below 7mm after application of tropicamide 0.38% and phenylephrine HCL 2.5% - at preoperative examination), elevated intraocular pressure, alpha-receptor inhibitor intake (e.g. tamsulosin) due to impeded mydriasis

Exclusion Criteria:

* Allergic to phenylephrine, tropicamide, sodium metabisulfite, disodium edetate, sodium hydroxide, hydrochloric acid, lidocaine hydrochloride, sodium chloride, disodium phosphate dodecahydrate, disodium phosphate dihydrate
* Allergic to anesthesia (amide type)
* Allergic to atropine derivates
* Heart disease, tachycardia, hypertensive crises
* Aneurism of big vessels
* Untreated hyperthyroidism
* Untreated closed angle glaucoma and narrow angles with tendencies to glaucoma by intake of mydriatic drugs
* Pregnancy, breast feeding and premenopausal women