cyrilzakka/clinical-trials huggingface dataset:
Mentors Offering Maternal Support (M-O-M-S™): A Prenatal Program for Decreasing Maternal Anxiety and Depression

The M-O-M-S project evaluates the effectiveness of the M-O-M-S program for improving birth outcomes and maternal-infant attachment and role satisfaction in a large military sample.

The M-O-M-S project is a longitudinal, multi-site, randomized controlled trial to test program effectiveness for decreasing prenatal maternal anxiety and depression and increasing self-esteem and resilience and assess the relationship to pregnancy complications, birth outcomes, postpartum maternal-infant attachment, role satisfaction and parental stress.

Eligibility Criteria:
Inclusion Criteria:

* Prima or multigravida, first trimester of pregnancy at consent, greater than or equal to 18 years old, active duty, a wife of an active duty service member, or a retiree

Exclusion Criteria:

* Anticipated permanent change of station during the study (unless going to another one of the study sites or able to complete all treatment components prior to move), dependent daughter of active duty or retired military, greater than 12 weeks gestation at consent, less than 18 years of age and inability to understand English.
Phase 1 Study Investigating Effects of HTL0009936 on Cognition and BOLD fMRI Signals in Healthy Elderly Subjects

To determine if treatment with HTL0009936 will lead to changes in neural activity, measured using the fMRI BOLD signal and ASL, in brain areas that are associated with spatial and working memory, learning and executive functioning.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of medical history, physical examination, vital signs, 12-lead ECG, haematology, blood chemistry, urinalysis and a pre-study psychological assessment.
* Mini Mental State Examination (MMSE) Score of ≥24.
* Intermediate or extensive metaboliser as determined by CYP2D6 genotype.
* Fluent English speaker.
* Right-handed.
* Not a regular smoker

Exclusion Criteria:

* Recreational drug use within 3 months prior to Screening Visit.
* Positive alcohol breath test.
* Positive urine drug screen.
* Consumption of large amounts of caffeinated drinks.
* Consumption of any food or any drinks containing cranberry, pomegranate, star fruit, grapefruit, pomelos, exotic citrus fruits or Seville oranges.
* Ultra-rapid or poor metabolizer as determined by CYP2D6 genotype.
* By self-report, taking two or more daytime naps per week which in the opinion of the investigator is likely to interfere with the ability of the subject to complete the study procedures.
* History of, or presents (in the opinion of the Investigator) with, significant neurological or psychiatric conditions.
* Personal or family history of congenital long QT syndrome or sudden death.
* Concomitant use of drugs that are metabolised by and/or are inhibitors of CYP2D6.
* Concomitant use of drugs that are substrates for the organic cation transporter 2.
* History of significant claustrophobia.
* Fulfils any of the MRI contraindications on the standard site radiography screening questionnaire (e.g. history of surgery involving metal implants).
Clinical Investigation of the Next-Generation Intraocular Lens

This study is a 6-month, prospective, multicenter, bilateral, randomized clinical investigation of the TECNIS Model ZHR00 and Model ZQR00 IOLs versus the TECNIS Symfony control IOL.

The study was conducted at 12 sites in the U.S.A and treated approximately 240 subjects, equally split between the two test groups and the control group.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral cataracts
* Potential for postoperative BCDVA of 20/30 Snellen or better
* Corneal astigmatism of 1.00 D or less in both eyes
* Normal corneal topography
* Clear intraocular media other than cataract in each eye
* Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries

Exclusion Criteria:

* Any clinically-significant pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils)
* Irregular corneal astigmatism
* Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
* Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery
* Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study
* Inability to achieve keratometric stability for contact lens wearers
* Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
* Subjects with diagnosed degenerative visual disorders
* Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects
* Use of systemic or ocular medications that may affect vision
* Prior, current, or anticipated use of tamsulosin or silodosin
* Poorly-controlled diabetes
* Acute, chronic, or uncontrolled systemic or ocular disease or illness
* Known ocular disease or pathology that may affect visual acuity or may require surgical intervention during the course of the study or may be expected to require retinal laser treatment or other surgical intervention during the course of the study
* Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
* Concurrent participation or participation within 45 days prior to preoperative visit in any other clinical trial
* Desire for monovision correction
Cutaneous DNA Damage Caused by UV-A Irradiation

The DIMUVA study aims to evaluate the correlation between cutaneous phototype and the nature and quantity of damage caused to cutaneous DNA after exposure to UV-A radiation.

Due to their capacity to damage Deoxyribonucleic acid (DNA), Ultra-Violet (UV) radiation is one of the causes of skin cancers.

Until recently, the genotoxic effects of UV-A radiation, were poorly identified, in particular their capacity to lead to the dimerization of pyrimidine bases .

It is well known that the response to UV-A and UV-B radiations is different depending on the cutaneous phototype.

Thus, the aim of this study is to determine the correlation between cutaneous phototype and the quantity and nature (CPD or oxidative lesions) of damage caused to cutaneous DNA after an ex-vivo exposure to UV-A and UV-B radiations.

Eligibility Criteria:
Inclusion Criteria:

* Male,
* Between 18 and 35 years old,
* Healthy volunteers,
* Cutaneous phototype 2 or 4 according to the Fitzpatrick classification,
* Affiliation to the French Social Security.

Exclusion Criteria:

* History of photosensibility,
* Active smoking or stopped since less than one year,
* Dermatological pathology or treatment contra-indicating cutaneous irradiation and skin biopsies,
* Any chronic pathology susceptible to interfere with the evaluations related to the protocol,
* Allergy to local anaesthetics,
* Volunteers who take drugs and/or food complements acting on oxidative stress in the 8 weeks preceding inclusion,
* Volunteers who have take paracetamol or aspirin within 7 days prior to the inclusion visit,
* Subject in exclusion period for another biomedical research study,
* Subject having exceeded the threshold of annual compensation for biomedical research.
A New Enzymatic Assay for Rapid Diagnosing of Central Nervous System Enteroviral Infection

A new enzymatic assay was developed by NMD Diagnostics for rapid diagnosis of Enteroviral CNS infection. This study will compare this assay to RT-PCR, by testing human CSF samples taken from children at the ER who are undergoing a spinal tap due to suspicion of meningitis.

MND's new enzymatic assay is based on the detection of a specific viral enzyme through the detection of its enzymatic reaction. The detection of a specific enzymatic reaction is indicative to the presence of the specific virus in a biological specimen. This study will compare this diagnostic assay to RT-PCR for diagnosis of enteroviral infection in cerebrospinal fluid. CSF samples will be taken from children undergoing a spinal tap at the pediatric ER due to a suspicion of meningitis. A total of 100 samples will be collected, from children 0-16 years old who's parents agreed on participation in the study. A comparison of the enzymatic assay to RT-PCR as well as calibration and validation of the new assay will be done with the harvested samples, for a rapid and accurate identification of Enterovirus in human cerebrospinal fluid.

Eligibility Criteria:
Inclusion Criteria:

* any child undergoing a spinal tap
* parents agreed on participation

Exclusion Criteria:

* refusal to participate in the study
Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years

The purpose of this study was to demonstrate the non-inferior HAI immune response of quadrivalent recombinant influenza vaccine (RIV4) vs licensed Egg-Based Quadrivalent Influenza Vaccine (IIV4) for the 4 strains based on the egg-derived antigen in all participants aged 3 to 8 years and to describe the immunogenicity and safety profile of RIV4 compared to IIV4 in participants aged 3 to 8 years.

Participants were enrolled on the day of their first vaccination and received 1 or 2 doses 28 days apart of either RIV4 or IIV4; depending on if they were previously vaccinated against influenza or previously unvaccinated against influenza, respectively; and were followed for 6 months after the last vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Aged 3 to 8 years on the day of inclusion
* Assent form has been signed and dated by the participant (according to local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations

Exclusion Criteria:

* Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
* Thrombocytopenia
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on the Investigator's judgment
* Personal or family history of Guillain-Barre Syndrome (GBS)
* Personal history of clinically significant development delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Exploring Telehealth to Deliver Me & My Wishes During Coronavirus-19

Due to Coronavirus-19, we are exploring the plausibility of delivering the Me \& My Wishes intervention via telehealth.

Me \& My Wishes are videos of nursing home residents talking about their preferences for care, including four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts. Knowing what residents want is essential to staff's ability to provide quality care and can inform family caregivers decision making especially in later stages of life as the resident's cognition declines-a time when family caregivers often feel unprepared. Persons with mild to moderate dementia can accurately express their everyday and end of life preferences, however, stereotypes persist about the decision making abilities of people with dementia that often prevent their involvement in conversations about care. The investigators propose to explore the feasibility of delivering Me \& My Wishes via a telehealth platform.

Eligibility Criteria:
Resident Inclusion Criteria:

* Identified as having Alzheimer's or related dementia
* Mild to moderate cognitive impairment (BIMS = 8-15, (MDS C0500) (nursing home residents only)
* Makes Self Understood = \<1 (MDS B0700)/present in medical record
* Understood By Others = \<1 (MDS B0800)/present in medical record
* Reside at the facility at least 2 weeks identified as a long-term resident
* Age \>65 years
* Speaks English

Family Inclusion Criteria:

* Speaks English
* Willing and able to watch the videos
* Willing to complete short surveys. Being unable to attend care conference to view the video (e.g. due to distance) will not exclude family from participating.

Staff Inclusion Criteria:

* Speaks English
* Willing to watch the videos
* Willing to complete short surveys

Resident Exclusion Criteria:

* Limited communication capacity (e.g. aphasia)
* Comatose
* Cognitively intact
* Severe cognitive impairment
Evaluation of Effectiveness and Safety of Xa Inhibitor for the Prevention of Stroke And Systemic Embolism in a Nationwide Cohort of Japanese Patients Diagnosed as Non-valvular Atrial Fibrillation

The efficacy and safety of a novel oral Xa inhibitor for stroke and systemic embolism, namely rivaroxaban, in non-valvular atrial fibrillation patients are evaluated in Japanese clinical practice.


Eligibility Criteria:
Inclusion Criteria:

Patients who meet all the criteria below

* Patients aged over 20 years
* Patients diagnosed with non-valvular atrial fibrillation
* Patients who are treated or will be treated with rivaroxaban
* Patients from whom written informed consent has been obtained

Exclusion Criteria:

Patients who meet any of the criteria below

* The following patients in whom rivaroxaban is contraindicated for use
* Patients with a history of allergies to the ingredients contained in this drug
* Patients having a hemorrhagic event (intracranial hemorrhage, gastrointestinal hemorrhage or other clinically significant hemorrhagic events)
* Patients having liver disease complicated with coagulation disorder or those having moderate or worse liver disorder (Grade B or C in accordance with the Child-Pugh classification)
* Patients having renal failure (creatinine clearance: \<15 mL/min)
* Women who are or are likely to be pregnant
* Patients who are treated with HIV protease inhibitors (including ritonavir, atazanavir and indinavir)
* Patients who are treated with oral or injectable formulations of azole antifungal drugs (including itraconazole, voriconazole and ketoconazole (excluding fluconazole))
Outcome After Conservative and Surgical Treatment of Splenic Injuries After Blunt Abdominal Trauma.

Retrospective study in order to investigate the outcome after conservative (with or without transcatheter arterial embolization) and surgical treatment of splenic injuries.

Background

Splenic injuries after blunt abdominal trauma are treated with increasing frequency without operation. Patients undergo observation and bed rest. In certain circumstances an additional transcatheter arterial embolization is performed. It is uncertain which splenic ruptures (injury grades according to Moore) are best treated non-operatively and which are best treated with an emergency operation. Furthermore the value of organ-preserving surgery (splenorrhaphy) is uncertain. In addition, the importance of transcatheter arterial embolisation is unknown.

Objective

Evaluation of outcome (splenic salvage rate, complications, survival) after conservative and surgical treatment. Evaluation of the importance of organ-preserving surgery and of transcatheter arterial embolization.

Methods

All adult patients with splenic injuries after blunt abdominal trauma are included (2002-2008). The patients charts are studied and the following main information retrieved: age, gender, mechanism of accident, grade of splenic injury, concomitant injuries, patient management in the emergency department (fluid administration etc.), diagnostic methods (ultrasound, computed tomography), treatment modalities (bed rest, surgery, embolization), complications of treatment, re-operations, long-term outcome.

Eligibility Criteria:
Inclusion Criteria:

* traumatic splenic rupture
* 16 years and older
Effect of Rotatory Upper Cervical Manipulation on Reflex Cervical Vertigo

Cervical reflex vertigo is a non-common cause of vertigo, caused by decreased afferent input from the upper three cervical segments to vestibular nuclei.


Eligibility Criteria:
Inclusion Criteria:

* cervical pain
* vertigo

Exclusion Criteria:

* severe osteoporosis
* blood circulation problem
Cohort of Patients Infected With SARS-CoV2 (COVID-19) or Suspected of Being

On 17th March 2020, 198 193 confirmed cases (7 730 in France) of COVID-19 infections and 7 854 deaths (175 in France) have been reported from 8th December 2019 in 157 countries. The rapid increase in cases on french territory has led to the transition of France to level 3 of the epidemic on 14th March 2020.

The natural history of the disease is still poorly understood, especially prognostic factors, which are crucial for the best medical care of patients in times of epidemics, when hospital capacities are under pressure.

A better knowledge of natural history, of prognostic factors, the development and validation of new diagnostic tests, the evaluation of medical care, will lead to a better medical care of patients infected with COVID-19.

The principal goal of the research is to assess the prognostic factors of the progression toward severe forms of the COVID-19 infection.

The secondary aims of the study are to contribute to answer some of the WHO research priority goals on COVID-19 infections:

* description of the natural history of the disease, its different forms, its clinical characterisation, its progression profile, the natural history of the disease linked to patient profiles
* evaluation and to comparison of different diagnostic methods, linked to the medical case
* description of the progression of the immune response during the infection and related to its outcome
* description of the replication and the excretion of the virus
* description of the progression of the biological markers during the infection and related to its outcome
* identification of the prognostic factors of the evolutive profile, especially if negative
* description of the patients care
* evaluation of the impact of the different therapeutic managements on the clinical outcome, the immune response, the viral load and the biomarkers.
* modeling of the epidemiologic impact
* identification of targets for treatment development
* analysis of cost data linked to the progression The population will include all patients infected with SARS-CoV2 ou suspected of being, who are taken care of at hospital.

The research is based on the collection of clinical and biological data from routine cares and on the biological analysis of blood samples.

The principal goal of the COVI-BIOME ancillary study is to identify gastrointestinal predictive factors for a severe form of the COVID-19 infection.

The principal goal of the COVIDOG ancillary study is to evaluate the sensibility and the specificity of canine olfactory detection for the volatile organic compounds of SARS-CoV2.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Patient admitted in an emergency unit or hospitalized, infected with SARS-CoV2 or suspected of being (the recruitment can occured during acute episode or during a follow-up visit)
* Written informed consent or emergency procedure
* Affiliated to health insurance system

Exclusion Criteria:

* Refusal of participation
* Patient under justice protection measure except guardianship and trusteeship
Specialized Cognitive-Behavioral Counseling Intervention to Reduce HIV Transmission Risk Behavior in HIV-Infected Men

This study will evaluate the effectiveness of a specialized cognitive-behavioral counseling intervention in reducing sexual risk behaviors in men who are HIV-infected and report having unprotected sex with male partners who are either not HIV-infected or do not know if they are HIV-infected.

Past research has shown that HIV-uninfected men who receive counseling regarding high-risk sexual behavior are less likely to engage in such behavior with other men. The rising rates of HIV infection among gay men suggest that some HIV-infected men are still engaging in high-risk sexual activity. There are several existing counseling interventions that focus on reducing high-risk sexual behavior, but the need exists for an intervention specifically targeted to HIV-infected men. This study will focus on the development of a specialized counseling intervention to help HIV-infected men identify and re-evaluate their "self-justifications," which are their thoughts, attitudes, and beliefs when deciding to engage in high-risk sexual activity with other men. In turn, this counseling may decrease the incidence of high-risk sexual behaviors, thereby reducing HIV infection rates among gay men. This study will evaluate the effectiveness of the specialized counseling intervention versus a standard risk-reduction counseling intervention in promoting safer sexual activity among HIV-infected men.

This study will consist of two phases. In Year 1, interviews will be conducted with 30 HIV-infected men who have engaged in high-risk unprotected sex within the previous 12 months with HIV-uninfected partners or partners with an unknown HIV status. The data resulting from these interviews will aid in the development of a specialized counseling intervention that is specifically geared for HIV-infected men. In Years 2 through 4, approximately 400 HIV-infected men will be randomly assigned to receive either the specialized counseling intervention or a standard counseling intervention. All participants will attend two counseling sessions: the first will occur at study entry and the second will occur 6 months later. Outcome measurements will be assessed at the second counseling session and again 6 months later, and will include self-reports of unprotected sex and laboratory testing for the presence of sexually transmitted diseases.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected
* Currently receiving HIV-specific primary medical care or mental health care
* Reports at least one episode of unprotected sex (receptive or insertive) with a male partner who is either not infected or does not know if he is infected with HIV (within 12 months prior to study enrollment)
* Plans to live in the San Francisco Bay Area for the next 12 months

Exclusion Criteria:

* History of intercourse on a regular basis with only one person
* Insufficient understanding of English
* Cognitive disorder that may affect ability to give informed consent
* Currently enrolled in any other behavioral or clinical HIV trials that could affect participation in this study