cyrilzakka/clinical-trials huggingface dataset:
Self-sampling and Human Papillomavirus (HPV)-Testing for Unscreened Women in Cervical Cancer Prevention

Scientific Context

High-risk types of human papillomavirus (HPV) are the causative agents for cervical cancer. Cervical cancer screening strategies rely on periodic Papanicolaou (Pap) testing. It's well-known that this test has significantly contributed to the reduction of mortality and morbidity due to cervical cancer. In France, it now seems that the screening strategy could be optimized. The two main ways are to reach the 7 million underscreened women (mass screening, self-sampling for HPV DNA testing) and to improve the screening test (HPV DNA testing, computer-assisted cytology). Self-collected vaginal samples (SCVS) for HPV DNA testing could be a relevant screening option: this technique appears reliable and it could allow to reach women who are never or seldom screened. Currently, there is no French data on the SCVS for HPV DNA testing.

The goal of this study is to determine the performance and acceptability of a population-based strategy using self-collected vaginal samples for HPV DNA testing to reach women who are not participating in cervical cancer screening.

Description of the project

This project (APACHE-1) is a part of a project called APACHE. APACHE-1 will be dedicated to the SCVS technical validation and to the comparison between different transports medium. Nine hundred women will be recruited from the 20 to 65 years consultants in the Tours University Hospital (CHRU of Tours) and in the IRSA (health centre for routine medical checkup).

Each woman will collect 2 SCVS with a nylon flocked swab (Copan® microRheologics™). The first SCVS will be put in a vial which contains a liquid medium. The second SCVS will be put in a dry vial. Then during the speculum examination the physician will collect a cervical sample with a Rovers® Cervex-Brush™ and then rinse it into a vial containing PréservCyt ™. A blind HPV DNA testing and genotyping (Inno-LIPA HPV Genotyping ™ Extra) will be performed in the virology laboratory of the CHRU of Tours on all samples (SCVSs and cervical samples performed by a physician). The performance of the SCVS to detect cervical HPV infection will be assessed (gold standard test = HPV DNA testing on cervical samples collected by the physician).

In a second time (APACHE-2), the researchers will investigate to what extent offering home obtained SCVS leads to participation of unscreened women. APACHE-2 will be registered on Clinicaltrials as another project.


Eligibility Criteria:
Inclusion Criteria:

* Women between 20 and 65

Exclusion Criteria:

* Menstruation
* pregnant
* Inability to give informed consent
* Vaccinated against HPV 16 and 18
* Total Hysterectomy
* treatment of CIN 1, 2 or 3
* Abnormal smear in the past year
* Smear in the past 2 years
* Virgin
Virtual Group Psychoeducational Discussions With Spanish-Speaking Mothers of Infants in Pediatric Primary Care

The goal of the proposed research is to test the feasibility and acceptability of a virtual group session which is intended to be offered universally to Spanish-speaking parents of newborns/infants attending pediatric primary care. The virtual session is intended to (1) enhance patient/family education about postpartum depression (PPD) and (2) Provide an orientation to families regarding relevant clinic and community psychosocial support resources available. The investigators will conduct a single-arm, open pilot of the session, which will be co-delivered by existing clinic staff (including social work and community outreach staff). Session contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs. The overall aim of the project is to Develop and pilot a virtual group augmentation of standard individual well-child care to improve (1) clinic screening procedures, discussion about and initial management of maternal depressive symptoms with immigrant Latinas and (2) patient symptom recognition, symptom disclosure, and subsequent treatment engagement


Eligibility Criteria:
Inclusion Criteria:

* Parent participants will be eligible if the preferred healthcare language is Spanish, if they are the mother of an infant (\<2 months of age) attending participating pediatric practice, and if she is not felt to have a contraindication to participation (e.g., condition in the parent that would preclude the ability to reasonably participate in a virtual group session) by clinic staff
* Clinic staff participants - facilitators of virtual groups

Exclusion Criteria:

* \<16 years old, preferred healthcare language not Spanish, not planning to attend participating practice, clinic staff determines contraindication to participation in group discussion
Virtual Exercise For Older Adults With Mild Cognitive Impairment

This project is designed to develop and evaluate an Internet-based exercise intervention (tai ji quan Moving to Improve Brain Health) using real-time videoconferencing for older adults with mild cognitive impairment (MCI).

The project has three major goals: (a) transforming an in-person tai ji quan brain health intervention protocol into an online (virtual) class protocol and evaluating its feasibility of implementation in older adults with MCI, (b) developing and evaluating online assessment and data ascertainment procedures that encompass cognitive and physical performance measures, and (c) conducting a randomized controlled trial comparing the effectiveness of this new online intervention protocol with a conventional stretching exercise group in older adults with MCI.

Eligibility Criteria:
Inclusion criteria:

* Self-report a change or decline in memory (corroborated by an informant)
* Record a score of ≤0.5 on the Clinical Dementia Rating (CDR) scale (with information derived from both the participant and an informant)
* Show no major impairment in cognitive function as indexed by a score of ≥24 on the Mini Mental State Evaluation (MMSE).

Exclusion criteria:

* Have participated in a rigorous and structured physical activity or exercise program (including Tai Ji Quan) in the past 6 months,
* Show major signs of depression as indicated by a score of ≥5 on the Geriatric Depression Scale
* Have major medical or physical conditions that preclude exercise, as determined by their healthcare practitioner
* Being unable to follow the consent process or sign the study consent form.
Effect of Pharmacist Initiated Recommendations On Prescribing For Participants In the Senior MEDS Personalized Medication Review

What are the demographic and medication utilization characteristics of participants in the Senior MEDS personalized medication review compared to other community-dwelling elderly, what is the level of satisfaction with Senior Meds, and does the Senior Meds program lead to changes in the participants' drug regimen?


Eligibility Criteria:
Inclusion Criteria:

* 55 or older

Exclusion Criteria:

* 54 or younger
Blood Collection Sub-Study for CRC Screening in Individuals 45-49 at Average Risk for CRC.

The primary objective of this sub-study, 2018-10B, is to collect blood specimens to assess new biomarkers for the detection of Colorectal Cancer (CRC).

Subjects who consent to enroll in Exact Sciences Protocol 2018-10, will be asked to participate in this sub-study. Subjects enrolled in the Exact Sciences Protocol 2018-10, who provide written informed consent to participate in this sub-study, will have a blood sample collected at enrollment.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is currently enrolled in Exact Sciences Protocol 2018-10
2. Subject is willing and able to provide a blood sample.
3. Subject is willing and able to sign informed consent.

Exclusion Criteria:

1. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
Impact of Suspected Preterm Labour on Cardiometabolic Profile and Neurodevelopment

Suspected preterm labour (SPL), define as the presence of regular and painful uterine contractions and cervical shortening, constitute a prenatal insult with potential long-term consequences. However, despite recent evidence demonstrating a suboptimal neurodevelopment at 2 years in this population, it remains under-recognized as a significant risk factor for neurodevelopmental disorders or other chronic diseases. The objective of this study is to assess the impact of suspected preterm labour during pregnancy on cardiometabolic profile and neurodevelopment during childhood (6-8 years).

Prospective cohort study including children whose mothers suffered a suspected preterm labor during pregnancy and paired controls. A neurodevelopment, cardiovascular and metabolic assessment at 6-8 years of age will be performed. A trained psychologist will carry out the neurodevelopment assessment. Body composition and physical fitness assessment will be performed by one trained pediatrician and nurse. Finally, cardiovascular assessment, including echocardiography and blood pressure, will be performed by two pediatric cardiologists. Data regarding perinatal and postnatal characteristics, diet, lifestyle and weekly screen time of the child will be obtained from clinical histories and direct interviews with the families. Primary outcome measures will include body mass index and adiposity, percentage of fat mass and total and regional lean mass, bone mineral content and density, cardio-respiratory resistance, isometric muscle strength, dynamic lower body strength, systolic and diastolic blood pressure, left ventricle (LV) systolic and diastolic function, general intelligence index, visuospatial working memory span, visual development test, visual acuity, index of emotional and behavioral problems.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Good understanding and sign of informed consent.

Exclusion Criteria:

* Multiple pregnancy
* Malformations
* Chromosomal diseases
* Prenatal infections
Pharmacokinetic Study of 4 mg Nicotine Lozenge.

This is a randomized, single center, open label, single dose, four way crossover study in fasted healthy male subjects to compare the pharmacokinetics of nicotine following administration of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg nicotine lozenge. Blood samples will be drawn at pre-specified intervals for a total of 12 hours post dose in each treatment session and plasma samples analyzed for nicotine levels.


Eligibility Criteria:
Inclusion Criteria:

- smoked commercially-manufactured cigarettes daily for the preceding 12 months and routinely smokes first cigarette within 30mins of awakening.

Exclusion Criteria:

* inability to refrain from smoking during confinement period, smoking tobacco in any other form other than commercially manufactured cigarettes, subject has used chewing tobacco or other tobacco products other than commercially manufactured cigarettes within 7 days of dosing
Nalbuphine as Adjuvant During Bilateral Suprazygomatic Maxillary Nerve Block for Pediatric Cleft Palate Repair

The aim of this study is to evaluate the efficacy of adding nalbuphine to bupivacaine via suprazygomatic nerve block for postoperative pain control and emergence agitation management in pediatrics aged from to 1 to 7 years who were maintained on sevoflurane inhalational anesthesia and scheduled for cleft lip and palate operation.

Cleft lip and cleft palate are the most common craniofacial abnormalities in children. Cleft surgery results in a profound sympathetic stimulation leading to hypertension, tachycardia, and bleeding. Postoperative pain can be severe, and many of these patients are at increased risk of opioid-induced respiratory depression. Emergence agitation (EA) is another common problem in these children, with an incidence between 10% and 80% after sevoflurane anesthesia. Inadequate postoperative analgesia combined with vigorous crying may lead to surgical complications including wound dehiscence, bleeding, and respiratory compromise. The anesthetic management of cleft surgery should ideally bound the intraoperative autonomic response and provide adequate analgesia without respiratory depression or EA. A combination of inhalation-based anesthesia and high-dose opioids has been described to block the autonomic response during surgical dissection; however, this technique may be associated with postoperative sedation and respiratory depression. Surgical infiltration with a local anesthetic and a vasoconstrictor promotes hemostasis and reduces the autonomic response intraoperatively but does not provide extended postoperative pain relief. Sensory innervation of the lip and palate is provided by branches of the maxillary nerve. Suprazygomatic maxillary nerve blocks have been shown to be opioid-sparing after cleft lip and palate surgery. The addition of opioid analgesic might both prolong the analgesia after a regional nerve block and reduce the incidence of EA.

Eligibility Criteria:
Inclusion Criteria:

1. Age 1 to 7 years.
2. Both genders.
3. American society of anesthesiologists (ASA) physical state I-II.
4. Children undergoing palate surgeries.

Exclusion Criteria:

1. Guardians' refusal
2. History of developmental delay or mental retardation.
3. Children with any co-morbidities.
4. Skin infection at the site of injection.
5. Bleeding diathesis.
6. Known allergy to any drugs used in this study.
Neurobiological and Neurocognitive Disturbances in First-episode Schizophrenia

We want to relate disturbances in first-episode schizophrenic patients in serotonin 5-HT2A receptors, brain structure, brain function, and information processing to each other and to psychopathology. Additionally, we want to examine the influence of 5-HT2A receptor blockade on these disturbances. We expect disturbances in the serotonergic system at baseline to correlate with specific structural and functional changes and with disruption in information processing as measured with psychophysiological and neurocognitive methods - and we expect 5-HT2A receptor blockade to reverse some of the functional and cognitive impairments. We do not expect any effect of treatment on brain structure

Patients and matched healthy controls are examined at baseline and again after the patients have been treated for 6 months with a combined 5-HT2A- and dopamine D2- receptor blocker. We have chosen the atypical antipsychotic compound, quetiapine, for the present study since this drug is characterized by a fast koff/low affinity for the dopamine D2 receptors. The purpose of the study is to examine pathophysiological and neuropsychological mechanisms - not treatment effects. We want to characterize neurobiological and functional endophenotypes or vulnerability indicators and to study their stability over time and their relation to treatment and contemporary psychopathology. To the extent that candidate endophenotypes can be characterized as stable and independent of treatment and contemporary psychopathology they will be analysed together with similar findings from previous (identical)cohorts of schizophrenic patients. Specific disturbances will also be related to candidate genes for schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* First-episode schizophrenia. The controls are matched for age, gender and parental socioeconomic status

Exclusion Criteria:

* Previous antipsychotic treatment, mental retardation, organic brain damage, and for the controls a psychiatric diagnosis or first-degree relatives with a psychiatric diagnosis
Randomized Trial With Dendritic Cells in Patients With Metastatic Colorectal Cancer

The different alternatives used since 1996 to treat metastatic colorectal cancer (MCRC) have increased the mean survival of these patients. This outstanding advance is due to the extended indications for resection of hepatic metastases and to the use of new chemotherapeutic drugs (fluoropyrimidine, irinotecan and oxaliplatin) and monoclonal antibodies (bevacizumab, cetuximab and panitumumab). However, none of these treatments is curative and the majority of patients are overwhelmed by the illness. The first line of treatment for MCRC is FOLFOX and the second, irinotecan plus cetuximab for patients with wild type KRAS gene (60%) with a 30% responses, and bevacizumab plus irinotecan with a 5-10% of responses, in patients with mutated KRAS (40%). A treatment with autologous dendritic cells (DCs) pulsed with autologous tumour antigens is proposed as a third line of therapy. A randomized phase II trial would be performed, by selecting two groups of patients, one of them would be treated with the best supportive treatment and the other with DCs plus the best supportive treatment. The aim of the study would be to analyze the outcome after 4 months of treatment. In patients treated with DCs, IFN-γ spot forming cells and proliferative responses would be determined pre and post treatment in lymphocytes stimulated with autologous DCs pulsed with autologous tumour antigens. Pre and post treatment serum levels of IFN-γ, TNF-α, TGF-β e IL-12, would also be measured.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years.
* Capacity of understanding and signing the informed consent and to undergo the study procedures.
* Previously treated with 2 lines of chemotherapy.
* ECOG \<= 2.
* Adequate renal, hepatic and bone marrow function
* Confirmed diagnosis of colorectal cancer with hepatic metastasis, suitable for biopsy.
* Availability of tumor tissue, for maturing dendritic cells
* RECIST.1 criteria

Exclusion Criteria:

* Clinically relevant diseases or infections (HBV, HCV, HIV).
* Pregnant or breast feeding women.
* Immunosuppressant treatment.
* Concurrent cancer, with the exceptions allowed by the principal investigator (PI).
Using Honest Placebos to Improve Pain Management in Hand Surgery Patients

America is in the midst of an opioid epidemic. One of the reasons opioid addiction and overdose deaths have recently increased is that doctors are frequently prescribing opioid medication as a treatment for pain. If it is possible to develop new ways of increasing the pain-relief patients experience from a set amount of opioids, then doctors might ultimately be able to prescribe fewer opioid medications, which could help curb the opioid crisis.

Although "placebos," a medication whose benefit derives solely from positive psychological factors rather than pharmacological factors, are often disparaged in medicine, research suggests that placebos can actually help reduce pain. In fact, there is reason to think that placebos are effective even when a patient knows they are taking a placebo.

The goal of the proposed study is to examine the feasibility of using an honest placebo to relieve pain for up to 20 real patients. People who are undergoing hand or wrist surgery or enrolled for upper extremity trauma in the Emergency Department and agree to participate will be asked to take placebo pills in addition to their standard course of opioid pills, given as part of standard care. Patients will also answer a few short questions over the phone once per day for seven days, and be invited to participate in an exit questionnaire at the end of the study. The investigators hypothesize that: 1) At least 50% of eligible participants will agree to enroll, 2) At least 80% of participants who are enrolled will be retained, and 3) Participants who are enrolled will take a placebo at least 50% of the time they also take an opioid pill


Eligibility Criteria:
Inclusion Criteria, University Orthopedics \& Department of Plastic \& Reconstructive Surgery:

* 18 years or older
* English Speaking
* Have a working phone
* Scheduled for hand or wrist surgery
* Able to provide informed consent Inclusion Criteria, Miriam Hospital Emergency Department
* 18 years or older
* English Speaking
* Have a working phone
* Able to provide informed consent
* Present for upper extremity trauma
* Are expected to be prescribed opioids at discharge
* Are expected to be discharged from the Emergency Department

Exclusion Criteria, University Orthopedics \& Department of Plastic \& Reconstructive Surgery::

* Known history of Substance Use Disorder
* Chronic pain
* Chronic opioid use
* The prescribing physician deems opioid medication not appropriate as part of standard care for any reason Exclusion Criteria, Miriam Hospital Emergency Department
* Known history of Substance Use Disorder
* Chronic pain
* Chronic opioid use
* Unlikely to follow-up (discretion of investigator and treating provider)
* Likely to receive surgical repair of the indicated injury
Role of Light Tracking Intervention in Children With Spastic Hemiplegia

The study aims to investigate the effect of visual light tracking on gait, selective motor control and sensory processing in children with spastic hemiplegic cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

* Age ranged from (4-7 years).
* They will be able to walk independently.
* They will have intact auditory pathways.
* They will have intact visual pathways.
* They will have a mild degree of spasticity graded from 1 to 1+ according to the modified Ashworth scale
* They will be mentally stable.

Exclusion Criteria:

* Any other neuromuscular disorders.
* Convulsion.
* Botox injection
* Fixed deformities of lower limbs and spine.
* Selective dorsal rhizotomy (SDR).
* Children with spasticity more than 1+ according to the modified Ashworth scale.
* Children with visual disorders such as squint myopia.
* children with auditory problems.