cyrilzakka/clinical-trials huggingface dataset:
Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis

The purpose of this study is to evaluate the safety and efficacy of Moxifloxacin AF Ophthalmic Solution compared to Moxifloxacin AF Vehicle in the treatment of bacterial conjunctivitis in patients one month of age or older.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with bacterial conjunctivitis in 1 or both eyes;
* Able to understand and sign an informed consent form. If subject is \<18 years of age, the informed consent must be understood and signed by the subject's legally authorized representative;
* Agrees to comply with the visit schedule and other requirements of the study;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Day 1;
* Presence of concomitant viral infection;
* Infants with ophthalmia neonatorum of gonococcal, Chlamydia, herpetic or chemical origin;
* Infants whose birth mothers had any sexually transmitted disease within 1 month prior to delivery;
* Infants undergoing treatment for retinopathy of prematurity;
* Contact lens wear during the course of the study;
* Only 1 sighted eye or vision in either eye not correctable to 0.6 logMAR units (20/80) or better;
* Use of medications, as specified in the protocol;
* Any systemic or ocular disease or disorder, complicating factors or structural abnormality that could negatively affect the conduct or outcome of the study;
* Known or suspected allergy or hypersensitivity to fluoroquinolones;
* Pregnant, lactating, or of childbearing potential and not using adequate birth control to prevent pregnancy;
* Other protocol-specified exclusion criteria may apply.
A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)

The main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.

The participants who take part in this trial will be asked to stay in the trial for about a year. The participants will be asked to visit the trial site 7 times during the trial. In between trial site visits, they will have scheduled phone calls with the trial site staff. They will also be asked to keep track of their cluster headaches at home with a headache diary.

Eligibility Criteria:
Inclusion Criteria:

* The participant has a diagnosis of cCH as defined by International Headache Society (IHS) International Classification of Headache Disorders third edition (ICHD-3) classification with a history of cCH of at least 12 months prior to the Screening Visit.
* The participant has a medical history of onset of cluster headache at ≤50 years of age.
* The participant has an adequately documented record of previous abortive, transitional and preventive medication use for cCH, for at least 12 months prior to the Screening Visit.
* The participant is able to distinguish cluster headache attacks from other headaches (such as tension-type headaches, migraine).

Exclusion Criteria:

* The participant has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway (anti-CGRP monoclonal antibodies \[mAbs\] and gepants).
* The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, complex regional pain syndrome).
* The participant has a history or diagnosis of chronic tension-type headache, hypnic headache, hemicrania continua, new daily persistent headache, chronic migraine or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or longer than 1 hour).
* Participants with a lifetime history of psychosis, bipolar mania, or dementia. Participants with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to Screening Visit.
* The participant has attempted suicide or is, at Screening Visit, at significant risk of suicide.
* The participant has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).

Other inclusion and exclusion criteria may apply.
Immersive Sensory Projections for Hospitalized Patients

The purpose of this study is to assess the impact of adding three sensory elements (visual, auditory, olfactory) on reducing discomfort in patients hospitalized in the intensive care unit/continuing care unit.

The IHP trial is multicenter, interventional, prospective, randomized, controlled, open-label study.

The study population consists of adult patients hospitalized in an intensive care or continuing care unit for medical or surgical reasons, conscious or unconscious under mechanical ventilation.

All patients participating in the study will be managed according to usual practices in intensive care and continuing care units. All patients and their relatives will be monitored and supported by the medical team as in normal practice.

The study will be offered to the patient or a close relative/trusted person on admission to hospital.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years ;
* Patient hospitalized in intensive care or continuing care unit for an estimated minimum of 48 hours;
* Patient hospitalized for a medical indication (including in the pre-surgical phase) or in the post-surgical phase;
* Patient or support person who speaks and understands French, has understood the research procedures and is able to complete the questionnaires;
* For women of childbearing age (non-menopausal), even for those on contraception: negative pregnancy test (urinary); If positive: completed by a biological test;
* Patient or trusted support person having been informed and having signed an informed consent form to participate in the study.

Exclusion Criteria:

* Deaf or blind patient;
* Asthmatic patient with background treatment;
* Epileptic patient or known history of convulsion;
* Known allergy or intolerance to essential oils or to a component of essential oils;
* Patient transferred from another intensive care unit;
* Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
* Breast-feeding or pregnant women;
* Patient or support person unable to understand information relating to the study (linguistic, psychological, cognitive, etc.);
* Unconscious patient with no relative or support person present;
* Homeless patient;
* Patient with known severe psychiatric illness such as chronic hallucinatory psychosis or paranoid syndrome;
* Patient participating in or being excluded from another clinical trial;
* Patient not covered by a social security scheme.
Improving Capacity to Reduce Fall-Related Injury Risk in Older Adults

Fall Arrest Strategy Training (FAST) is a unique, simple exercise program designed to improve one's ability to prevent injury when a fall is unavoidable. Women are more likely to participate in fall prevention programming than men despite risk of serious fall related injuries such as head injury similar in both men and women. The purpose of this project is to test differences between men and women's physical capacity to control the downward descent of a forward fall and prevent injury and to understand factors that influence participation of women and men in fall prevention programming. A total of 60 seniors (30 men and 30 women) age 60 years or older will do their regular activities for 12 weeks followed by 12 weeks of FAST training. They will be tested before and after for muscle strength, balance and their ability to land and descend in a simulated forward fall using a safe protocol in our lab. Group discussions among women and men after FAST will help us determine facilitators and barriers to exercise participation.

The purpose of this proposed study is to advance our knowledge of this innovative and simple training program, FAST, to determine if it has potential to improve the physical capacity to arrest a fall and reduce injury risk in older community-dwelling women and men. Using our novel lab-based energy absorption and strength measures, we will be able to compare fall-arrest capacity changes in older men and women.This study will also help to inform strategies to engage older men in exercise programming.

Research Goals and Objectives: The principal research questions of this study are:

1. Does the FAST improve fall arrest capacity in older women and men as compared to usual activity (wait control period)?,
2. Does FAST increase arm muscle strength, response time, mobility and balance control compared to usual activity? ,
3. Are there sex differences in fall risk changes, fall arrest capacity, and chance of head impact? and
4. Do men differ from women in their perceptions of the barriers and facilitators to participating in FAST? The hypotheses are that: 1) FAST will result in greater improvements in energy absorption, UE strength, response time and mobility compared to usual activity for both older men and women; however 2) men will demonstrate enhanced fall arrest capacity and 3) will identify unique barriers and facilitators to participation compared to women.

The study is a quasi-experimental pre-post design with a wait list control period where 60 men and women, age 60 years or older will be recruited to participate in FAST.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 60 years living in the community

Exclusion Criteria:

* recent upper body injury or pain,
* recent or history of more than one distal radial fracture,
* history of upper extremity neurological conditions or conditions contradicting upper extremity strength testing or training,
* signs of severe cognitive impairment identified with the mini-Cog
* unable to safely ambulate independently in the community
Benefits of Applying Neuroprosthesis for Improving Reaching and Grasping Functions in Stroke Patients

Functional electrical stimulation (FES) is a process that uses low intensity electrical pulses generated by an electric stimulator to create muscle contractions. By contracting muscles in a specific sequence, one can generate various body functions such as grasping, walking, and standing. Final goal of the study is to evaluate if FES training when applied early during rehabilitation will help stroke patients to use their hands more effectively after discharge from a rehabilitation facility, compared to those patients who have not received FES training.

Neuroprosthesis are systems that apply functional electrical stimulation to cause muscle contractions. If the muscle contractions are sequenced properly one can generate various functions such as grasping, standing, and walking. Recent studies of others and our pilot study indicate that a neuroprosthesis can be successfully applied as a training device to help stroke patients who have hemiplegic arm to relearn how to reach and grasp various objects. The objective of this research program is to confirm these preliminary results with the broader population of stroke patients, and if successful to propose a method to introduce this rehabilitation treatment into Toronto Rehabilitation Institute, Stroke Unit as a primary intervention for hand function recovery. Specifically, our aim is to1)develop an exercise protocol that uses a neuroprosthesis for reaching and grasping developed by our team in combination with the standard physiotherapy treatments to enhance recovery of hemiplegic arm and hand; and 2) assess qualitatively and quantitatively improvements in the reaching and grasping functions achieved with standard rehabilitation treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be motivated to participate in the FES study, and must sign the letter of consent.
* Patients must have hemiplegia and the stroke must be confirmed with a CT scan.
* Patients must understand that the role of this study is to enhance recovery and not to guarantee it.

Exclusion Criteria:

* Patients who is motivated and does not sign the letter of consent.
* Patient who has serious cognitive or psychological impairments.
* Patients who has skin rush, allergy or wounds.
* Alcohol or drug abuse.
* Edema in his/her upper extremity.
* Patients with Shoulder Hand Syndrome
* Global aphasia
* Patients who shows early recovery of the function.
Facilitators and Barriers to Dental Care in Head and Neck Cancer Patients

The aim of this study is to identify potential facilitators and barriers to dental care in head-neck cancer patients from the perspective of affected patients, dentists, and oncologists (specialists in radiotherapy and specialists in otolaryngology).

Patients as well as dentists and oncologists will be interviewed in semi-structured individual interviews. The interview guide used will align with the 14 domains of the Theoretical Domains Framework. Through qualitative content analysis, both facilitators and barriers to dental treatment for head-neck cancer patients will be identified.

Eligibility Criteria:
Inclusion Criteria:

* Patients with head and neck tumors whose health condition allows for the conduction of an interview
* Dentists practicing in Germany
* Specialists in otorhinolaryngology practicing in Germany
* Specialists in radiation therapy practicing in Germany

Exclusion Criteria:

* Missing consent for the study
* Health condition that does not allow the conduction of an interview
Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure: CHF-CePPORT

Chronic Heart Failure (CHF) is a growing public health issue in Canada. Hospital re-admission within 1-year after diagnosis is 25-40%, and the 5-year rate of CHF death is 50%. Counseling by multidisciplinary health care teams helps CHF patients to improve self-care behaviors (for medications, diet, exercise, smoking cessation and symptom monitoring), and this reduces the rate of death and CHF hospitalization. In the absence of intervention, patient adherence to these behaviors is below recommended standards and quality of life among CHF patients becomes progressively compromised. A major challenge is to make self-care counseling available without overtaxing health care resources.

This year multicenter clinical trial will establish and evaluate a Canadian e-platform that provides multidisciplinary e-counseling to help patients with CHF to initiate and maintain recommended self-care behaviors. The investigators will recruit 298 CHF patients in Toronto, Montreal and Vancouver. The investigators hypothesize that a 12-month program of e-Counseling + Usual Care versus general eInfo + Usual Care will improve quality of life, self-care behaviors, program engagement, and heart health. This proposal is based upon previous clinical trials in CHF, e-health and preventive lifestyle counseling by our team. The novel contribution of this research is that it will establish an infrastructure for a pan-Canadian e-platform in preventive e-counseling for CHF. A key feature of this proposal is that our multidisciplinary team will work with professional heart health organizations to share our findings and e-health resources with the public and other health care professionals in Canada, which will help to galvanize research and clinical work in eCounseling. Our clinical trial will strengthen eCounseling services in order to improve the quality of life of patients with CHF.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients 18 years of age who are diagnosed with heart failure with reduced ejection fraction ("systolic HF") corresponding to New York Heart Association Class II-III for 3 months prior to enrolment;
2. documentation of LVEF 40%;
3. subject has access to a personal computer;

Exclusion Criteria:

1. Documentation at enrolment of renal failure, significant liver disease or poorly controlled diabetes mellitus;
2. persistent systolic or diastolic hypertension \[systolic \> 170 mmHg or diastolic \> 100 mmHg despite antihypertensive therapy;
3. CHF secondary to cardiovascular co-morbidities/procedures;
4. previous heart transplant or wait listed for heart transplant at time of enrolment
Machine Learning-based Classification of Symptom Clusters and Online CBT

To breakthrough the bottleneck identified, we will conduct a cross-sectional study to develop a symptom clustering model for depression and anxiety. A wide range of statistical methods as well as machine learning approaches were explored, and a cohesive hierarchical clustering algorithm will be used. After developing the model, a symptom-matched intervention program based on problem solving therapy will be formulated. We are supposed to examine whether its use for personalizing symptom-matched psychological treatment can lead to improved patient outcomes, compared with usual care. This project is expected to provide a new and precise method for the emotion management, which will provide a standardized intervention pathway combining screening with treatment for the management of depression symptom and anxiety symptom. A preciser intervention matched to individual symptoms may provide important insight in improving patient outcome as well as a standardized mood management pathway targeting to the early detection and intervention for community residents.


Eligibility Criteria:
Inclusion Criteria:

* Meets the criteria of PHQ-9 and or GAD-7 ≥5 at baseline measurements

Exclusion Criteria:

* Patients who report the presence of suicidal thoughts in entry 9 of the PHQ-9 on any psychometric measurements, referred to the Wuhan Psychological Hotline Platform; and
* Those who are currently suffering from mental illness or are being treated with antipsychotic drugs;
* Women during pregnancy or within 3 months after delivery.
Evaluation of a Telephone Follow-up Procedure on the Quality of Life in Psychogenic Non-epileptic Seizures

The goal of this study is to evaluate effectiveness of the phone follow-up method compared to the conventional filler taken one.

This study is a multicenter, non-drug therapy and randomized research trial, comparing a group of patients integrating the phone monitoring device (DST group) to a control group where patients are cared for in the usual way.

Subject recruiting modalities:

The study population represents patients diagnosis, PNES confirmed by following by the video-EEG, recorded in a center of epilepsy and in different CHU and informed of the diagnosis of PNES in a standardized manner.

Patients were recruited during their hospitalization video-EEG is conducted in part of the diagnostic workup of drug-resistant epilepsies, or demonstrations paroxysmal undetermined which may prove to be PNES.

Usual care:

After diagnosis of PNES: orientation psychiatric care or CMP liberal and meeting biannual with the neurologist.

In the study:

* For patients in both groups: Management usual care and, in addition, quotation questionnaires of quality of life and evaluation by a neuropsychologist biannually for 24 months after the appointment with the neurologist.
* For patients in the DST group only: Phone calls by psychologist at J 15, at 2 months, then every 2 months until M12. The device telephone follow (DST) consists of telephone calls (D15, M2, then every 2 months until M12) of the patient by an external independent psychologist designed to inform the patient about its pathology, promote acceptance of diagnosis, support the patient in his approach to care encouraging psychiatric observation. The device does not replace psychiatric counseling recommended.

Eligibility Criteria:
Inclusion Criteria:

* Patient above 18 years old
* Affiliation to social security
* Evolution disorders for over three months with at least 3 psychogenic non-epileptic seizures spaced over 24 hours and less than two years
* Diagnosis of PNES (associated or not with epilepsy) or laid confirmed following a video-EEG examination
* Standardized announcement of the disease made by a neurologist participant / PHRC training
* Good understanding of the French language
* Patient consented to participate in the study

Exclusion Criteria:

* Acute psychiatric pathology at the time of inclusion warranting urgent hospitalization (acute suicidal risk, Table delusional ...)
* Progressive neurological pathology intercurrent susceptible to aggravation for the duration of the study (glioma, multiple sclerosis, dementia ...)
* A patient who can not physically comply with the six-monthly review at the discretion of the investigator (planned move ...)
* Simultaneous participation to another therapeutic intervention study during the first 12 months
Diesel Exhaust Particles and Leukotriene Production

The purpose of this study is to measure the effects of allergens and/or diesel exhaust particles in the nose to learn more about allergic responses in individuals with cat allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 65 years old.
2. Positive prick (epicutaneous) skin test to standardized cat with a wheal equal to or greater than 3 mm and with a surrounding flare.
3. Ability to give informed consent.

Exclusion Criteria:

1. Pregnancy or breast-feeding. (Pregnancy and the period during breast feeding can affect nasal congestion and be a confounder in this regard.)
2. Systemic corticosteroid use within the previous three months or anytime during the challenge protocol.
3. Topical nasal corticosteroid use within the past month or anytime during the challenge protocol.
4. Systemic antihistamines or decongestant use within past two weeks or anytime during the trial.
5. Chronic sinusitis or chronic non-allergic rhinitis.
6. Use of reserpine.
7. Cigarette smoking within the past year or during the challenge protocol
8. Use of topical nasal antihistamines, chromoglycolates (chromolyn, Cromlon®), decongestants or non-steroidal anti-inflammatory agents (NSIADS) within the preceding week or anytime during the challenge protocol.
9. Present or treatment within the past 10 years with allergy immunotherapy (injections).
10. Present or past treatment with anti-IgE therapy.
11. Any unusual exposure to air pollutants (e.g., working as a diesel mechanic) that, in the opinion of the investigators, might compromise the individual's ability to participate in the study.
12. Living arrangement where the subject has a cat dwelling within the subject's habitation.
13. Any serious heart, lung, neurological or kidney disease that in the opinion of the investigators would impair the individual's ability to participate in the study.
14. Use of asthma-required medications.
Study of WVE-003 in Patients With Huntington's Disease

This is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and PD of WVE-003 in adult patients with early-manifest HD who carry the targeted single nucleotide polymorphism (SNP) - SNP3.


Eligibility Criteria:
Inclusion Criteria:

1. Presence of the A variant of SNP3 on the same allele as the pathogenic CAG triplet expansion
2. Ambulatory, male or female patients aged ≥25 to ≤60 years
3. Clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score = 4
4. UHDRS Total Functional Capacity Scores ≥9 and ≤13

Exclusion Criteria:

1. Malignancy or received treatment for malignancy, other than treated basal cell or squamous cell carcinoma of the skin, within the previous 5 years
2. Received any other study drug, including an investigational oligonucleotide, within the past 1 year or 5 half-lives of the drug, whichever is longer, with the exception of the following:

   a. Received WVE-120101 or WVE-120102 within the last 3 months
3. Implantable CNS device that may interfere with ability to administer study drug via lumbar puncture or undergo MRI scan
4. Inability to undergo brain MRI (with or without sedation)
5. Bone, spine, bleeding, or other disorder that exposes the patient to risk of injury or unsuccessful lumbar puncture
6. Previously received tominersen