cyrilzakka/clinical-trials huggingface dataset:
Game-Based Intervention to Promote HPV Vaccination

This study will examine the feasibility and acceptability of an innovative game-based intervention designed for families of youth aged 11-14 to promote HPV vaccination; will explore changes in key outcomes and related measures; and will identify factors contributing to or impeding effective implementation in health clinic settings. The intervention and its approach have the potential to reduce health disparities in HPV-associated cancers in youth via low-cost technology and timely intervention.

Guided by Social Cognitive Theory, we propose to

1. examine the feasibility and acceptability of a new HPV preventive intervention, the HPV Detective video game, designed for youth and their parents;
2. explore pre-post, intervention-related change in vaccine intent and uptake as well as change in theoretically posited intervention mediators; and
3. assess the potential for broader intervention implementation. Using a sequential mixed-methods, 2-group (intervention vs usual care), longitudinal design, 64 parent-youth dyads (32/per study condition) will be recruited.

Parent-youth dyads in the intervention will play HPV Detective (tablet format) at the clinic prior to the healthcare provider visits. The control dyads will receive standard clinic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Youth: (1) 11-14 years old; (2) have not received the 1st dose of HPV vaccine; (3) speak and read English
* Parent: (1) are the parent/legal guardian of the participating child; (2) ≥ 18 years old; (3) speak English or Spanish; (4) own a smartphone; (5) agree to participate in the research activities at study sites; (6) agree to receive text messages.
* Healthcare providers: (1) ≥ 20 years old; (2) speak English or Spanish); (3) work at study sites

Exclusion Criteria:

* Individuals are unable to comprehend the consent or assent forms due to cognitive issues
COGNITIVE BEHAVIOURAL THERAPY FOR TREATMENT OF CHRONIC NON-SPECIFIC LOW BACK PAIN

To explore the effect of adding cognitive-behavioral therapy to physical therapy interventions in patients with chronic non-specific back pain.

Studies suggest that patients with LBP benefited when standard rehabilitation approaches were supplemented with graded exercise . There is adequate information to allow clinical implementation of graded exercise by physical therapists, In contrast, there is less information available for physical therapy implementation of graded exposure. LBP rehabilitation based on graded exposure principles Therefore, the purpose of this study is to review the available evidence for graded exposure and to describe physical therapy application of graded exposure for patients enrolled in clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. Patient's age between 25-40 years.
2. Patients have persistent Chronic Non-specific LBP for at least 3 months with or without leg pain. Leg pain won't exceeds mechanical behaviors.
3. Score of 24 fear avoidance questionnaire.
4. Symptoms of hypersensitivity, secondary punctate or pressure hyperalgesia and fear of movement as a central sensitization symptoms

Exclusion Criteria:

* 1-History of previous back surgery. 2- History of previous hip, knee or ankle surgeries. 3- Systemic inflammatory diseases. 4-Tumors. 5-Red flags of back pain 6-Patients with disc pathology and radicular pain 7- spinal fracture or spinal surgery 8- systemic disease or TB of spine widespread constant non-specific pain disorder, pain without a clear mechanical behavior
Self- Versus Conventional-swabbing for COVID-19 Screening (COVISWAB)

Self-swabbing requires less personal protective equipment and could allow to test more people and even to do quick self-diagnosis if antigenic tests are available.

In a preliminary study on 190 medical students, the investigators have shown that self and conventional swabbing were identically well-accepted with equivalent level of pain and discomfort induced by swabbing. In a sub-group of this sample, the investigators have shown that the quality of the 2 sampling methods were equivalent.

The goal of this large study in the general population is to confirm these findings in an adequately powered study. Such results would allow to develop self-swabbing for large screening campaigns and eventually self-diagnosis using antigenic tests.

All consecutive subjects coming to the 2 dedicated centers for COVID-19 screening in Clermont-Ferrand University hospital (one for medical students and one for the general population) will be asked to be included in the present study. They will be randomly assigned to either supervised self-swabbing followed by conventional swabbing led by a healthcare professional or the other way round.

All the subjects will have to complete a brief questionnaire including demographical characteristics (age, sex, height, weight, eye color), potential symptoms (asthenia, fever, anosmia...) anticipated pain and discomfort and previous nasopharyngeal swabbing experience. Pain, discomfort and overall acceptability of the procedure will be completed just after completion of the swabbing.

Eligibility Criteria:
Inclusion Criteria:

* Any subject coming for nasopharyngeal swabbing for SARS-CoV-2 screening
* Fluent in French (both oral and written)
* Able to give an eclaired consent

Exclusion Criteria:

* Contra-indication to nasopharyngeal swabbing
* Refusal to participate
* Pregnant women
The Effect of Different Dosages of Solute Clearance on Outcome in Twice Weekly Hemodialysis Patients

Adequacy of solute clearance makes a profound impact on clinical outcome in maintenance hemodialysis patients. Thus far, guidelines on the target of solute clearance (Kt/V or URR) are based on patients with three dialysis sessions per week. However, quite a few patients have their dialysis sessions twice per week in China. The dialysis target of solute clearance in this population remains to be elucidated. The aim of this study was to explore the optimum target solute clearance (Kt/V or URR) in maintenance hemodialysis patients with two dialysis sessions per week. Two groups of hemodialysis patients with different Kt/V (1.2 ≤ Kt/V \< 1.7 versus Kt/V ≥ 1.7) will be followed until 96 weeks in this prospective, randomized, multi-center, interventional study.

This is a prospective, randomized, multi-center intervention study. 400 maintenance hemodialysis patients with twice dialysis sessions per week will be enrolled into the study. All the patients have their baseline Kt/V between 1.2 and 1.7 (1.2 ≤ Kt/V \< 1.7). After treatment intervention, the patients will be randomized to two groups according to their different Kt/V (1.2 ≤ Kt/V \< 1.7 vs. Kt/V ≥ 1.7), then the patients will be regularly followed up at baseline, 12 weeks, 24 weeks, 48 weeks, 72 weeks and 96 weeks. Clinical outcomes such as mortality, complications and life quality between the two groups will be investigated.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing maintenance hemodialysis for more than 12 weeks were included in the study.
2. The patients have their dialysis sessions twice weekly and have baseline Kt/V between 1.2 and 1.7 (1.2 ≤ Kt/V \< 1.7).
3. Age from 18 to 80, male or female.
4. Patients have long term vascular access.

Exclusion Criteria:

1. Patients with an expected survival less than 12 months.
2. Without informed consent.
3. Unstable organ disease such as uncurable cancer,active inflammation disease and mental disease.
4. Patients with an expected follow up less than 48 weeks,such as planned kidney transplant.
5. Other conditions regarded as unsuitability by investigator, such as pregnancy, alcohol or drug indulgence. A dry weight more than 90 kg is also excluded in the study.
Trait Anxiety and Defensive Networks

to examine the association between trait and defensive network connectivity and the modulatory effect of oxytocin on it

Individuals with high trait anxiety show stable anxiety proneness even in the absence of real threat, which could be a result of intrinsic hyper-connectivity in the defensive systems. In the present study, healthy subjects' trait anxiety levels will be assessed by the sub-trait inventory of the State-Trait Anxiety Inventory. Then two experiments using resting-state fMRI technique will be conducted to first map how hubs in the defensive systems organized in high anxious individuals in a stimuli-free situation (Experiment 1) and then we will examine the modulatory effect of the intranasal administration of oxytocin on functional connectivity in these independently defined defensive networks (Experiment 2).

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* females should not be pregnant or during menstruation.
A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )

To determine the clinically safe and effective dose of intravitreal ISIS 2922 alone and as an additive antiviral therapy to ganciclovir in AIDS patients with cytomegalovirus (CMV) retinitis.

In Stage 1 of the study, 20 patients receive one of two doses of ISIS 2922 on days 1, 8, and 15 (Induction) then every 14 days (maintenance), with ganciclovir given daily during both Induction and Maintenance. Escalation to the second dose does not occur until all patients at the first dose level have reached their first maintenance dose (day 29). In Stage 2 of the study, 174 patients are randomized to receive either a) ISIS 2922 at the dose established in Stage 1 on days 1, 8, and 15 and then every 14 days, with ganciclovir given daily during both Induction and Maintenance, or b) ganciclovir daily for 14 consecutive days and then a lower dose as maintenance. Patients may continue to receive ISIS 2922 biweekly if the dose is safe and their CMV retinitis is clinically controlled. Per 2/8/96 amendment, patients are now in Stage 2 at 150 mcg.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* AIDS.
* CMV retinitis that is not adequately controlled (previously diagnosed patients with smoldering CMV retinitis or those with active CMV retinitis borders on indirect ophthalmoscopy).
* No more than one previous progression of CMV retinitis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions in the eye to be treated are excluded:

* External ocular infection.
* Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other disease of the fundus.
* Ocular condition that will obstruct visualization of the posterior ocular structures.
* Retinal detachment.
* Silicone oil in eye.

Patients with the following other symptoms or conditions are excluded:

* Known or suspected allergy to phosphorothioate oligonucleotides.
* Syphilis.
* Retinal pigment epithelial stippling not associated with CMV retinitis.
* Pseudoretinitis pigmentosa.
* Chronic diarrhea that would impair absorption of oral ganciclovir.
* Intolerance to ganciclovir.

Concurrent Medication:

Excluded:

* Foscarnet or other anti-CMV agents other than ganciclovir.
* Mellaril.
* Stelazine.
* Thorazine.
* Clofazimine.
* Ethambutol/fluconazole combination.
* Investigational medications for CMV retinitis.

Concurrent Treatment:

Excluded:

* Investigational procedures for CMV retinitis.

Patients with the following prior conditions are excluded:

* History of surgery to correct retinal detachment in eye to be treated.
* History of intolerance to ISIS 2922.

Prior Medication:

Excluded:

* Prior ganciclovir implant for CMV retinitis.
* More than 4 months of prior ganciclovir.
Critical View of Safety in Laparoscopic Cholecystectomy

This prospective cohort study aims to assess feasibility and safety of the approach of critical view of safety during laparoscopic cholecystectomy

Since the introduction and routine use of laparoscopic cholecystectomy in the 1990s, the reported incidence of biliary injuries has doubled to 0.4%.

Many factors have been shown to influence the risk of biliary injury including patient factors (obesity, older age, male gender and adhesions), local factors (severe gallbladder inflammation/infection, aberrant anatomy and haemorrhage) as well as surgeon experience.

Identifying the common bile duct as the cystic duct is the commonest cause of major bile duct injury Active identification of cystic structures within Calot's triangle is the key to a reduction in biliary injury. Strasberg first coined the term 'critical view of safety' (CVS) in 1958 and this approach of identification of cystic structures has been adopted by many surgeons as the standard of operative technique to reduce the incidence of biliary injury.

To fulfil the criteria for a CVS requires Calot's triangle to be cleared free of fat and fibrous tissue ('fat cleared'), for the lowest part of the gallbladder to be dissected free from the cystic plate ('liver visible') and for there to be only two structures entering the gallbladder ('2 structures').

The published rate of bile duct injury with this approach is very low However more studies are needed to assess risk benefit rate of this approach.

Eligibility Criteria:
Inclusion Criteria:

* include all patients who will have laparoscopic cholecystectomy

Exclusion Criteria :-

* Emergency laparoscopic cholecystectomy
* Liver cirrhosis
* HCV \& HBV
Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema

The objective of the study is to assess the effect of a new Armsleeve, worn during the night during maintenance phase of upper limb lymphoedema treatment in combination with Day-time usual lymphology hosiery.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral secondary upper limb lymphoedema of stage II or III, following breast cancer
* Patients hospitalized for an intensive phase of decongestive lymphoedema therapy (DLT) for whom a decrease of lymphoedema volume has been achieved during hospitalization
* Lymphoedema with evident pitting sign (assessed as ++ or +++)
* Requiring compression therapy for, at least, the next 3 months.
* Affected arm that fits with one of the 6 standard sizes of the Auto-Adjustable MOBIDERM® armsleeve provided.
* Signed informed consent prior to any study-mandated procedure.
* Not under any administrative or legal supervision.
* Covered by a health insurance system

Exclusion Criteria:

* Stage I lymphoedema
* Active cellulitis
* Lymphoedema associated with active cancer needing acute chemotherapy
* Motor and sensitive neurological deficiency
* Post-operative oedema (i.e acute oedema following breast cancer-related surgery)
* Patient participating in any other clinical study
* Unlikely to be followed up to 3 months with clinical assessment
How Body Awareness Promotes Mental Health During Yoga and Physical Exercise

The integrity of interoceptive networks is linked to resilience against depressive symptoms, whereas degradation of these networks is linked to apathy and deficits in emotion processing. The goal of this study is to compare two major styles of yoga and cardiovascular exercise through a 10-week training program to promote interoceptive awareness. The researchers hypothesize that improvement in affective symptomatology will be correlated with better interoceptive development. Changes in mood related symptoms and interoception will be assessed at baseline, week 12 and week 14, in a cohort of adults aged 18-55.

A recent annual survey of U.S. college freshman has found consistently declining levels of emotional health over the past 25 years. Exposure to such stress can have profound longitudinal effects on well being, influencing risk for disease later in life. Physical exercise is linked to benefits across a variety of physical and psychological domains. While the affective and physiological consequences of exercise are well-documented, how they work to improve subjective well-being is unclear. It has been suggested that exercise promotes well-being by increasing interoception. The integrity of interoceptive networks is linked to resilience against depressive symptoms, whereas degradation of these networks is linked to apathy and deficits in emotion processing. The goal of this study is to compare two major styles of yoga and cardiovascular exercise through a 10-week training program to promote interoceptive awareness. The researchers hypothesize that improvement in affective symptomatology will be correlated with better interoceptive development. Changes in mood related symptoms and interoception will be assessed at baseline, week 12 and week 14, in a cohort of adults aged 18-55.

Eligibility Criteria:
Inclusion Criteria:

* 18-55 years of age
* Have negative mood symptoms (depression, anxiety, stress)
* Is healthy and independent enough in daily life to attend study classes

Exclusion Criteria:

* Pregnant women or women who are planning to become pregnant during the study period
* History of structural brain disease, mass lesion, stroke, epilepsy
* History of addictive disorder or significant substance abuse
* Neurological disorders or reversible causes of dementia
* Suicidality or history of psychosis
* Currently attending regular yoga or aerobic exercise practice, or participated in more than 6 formal meditation, aerobic, or yoga classes in the past 12 months
* Self-reported cognitive impairment and other disorders which may preclude safe participation in the program including acute major depression, bipolar or severe personality disorder
Multicenter Clinical Study on the Optimal Treatment Protocol and Outcome of Cough Variant Asthma With Chinese and Western Medicine

To explore the disease outcome prognosis of cough variant asthma by observing the outcomes of cough variant asthma and the effects of Chinese and Western medicine interventions, and to provide a scientific basis for optimizing the treatment protocol of combined traditional and Western medicine for cough variant asthma. This is a multi-center, non-randomized, prospective cohort study. This study started in March 2022 and is going on now. On an informed consent basis, a cohort of 164 patients with diagnosis of CVA are engaged. All patients will receive 8-week treatment (ICS/LABA plus Chinese herbal medicine for trial group while ICS/LABA only for control group) and be observed in next 24 weeks. Patients will be followed up every 2 weeks during treatment period and every 4 weeks in observation.The feasibility and correctness of the study will be supervised by two supervisors. To ensure that participants adhere to their follow-up plans, we remind them of their fixed visiting by phone or message. Additionally, incentives are used to appreciate participants for their cooperation.


Eligibility Criteria:
Inclusion Criteria:

1. conform to diagnosis of CVA;
2. 18 years≤age≤65 years;
3. agree to participant in this trial.

Exclusion Criteria:

1. comorbidity of respiratory and pulmonary infections;
2. history of mental illness;
3. comorbidity of heart and cardiovascular, liver, kidney and hematopoietic function and other severe diseases;
4. participants of other clinical trials who may make a difference in our trial;
5. treatment with other Chinese herb.
Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis

Participants who meet the eligibility criteria and who consent to participation or whose parents/legal guardian consent to their participation, will be enrolled in the study for a period of up to 14 days. Enrolment visit (Day 1) assessments for all participants will include the collection of throat swabs, testing by staff at the site using the ellume·lab Group A Strep Test and testing for Group A Streptococcus by a central laboratory using bacterial culture and polymerase chain reaction (PCR). All participants will be followed up with a phone assessment of adverse events between Days 2-14.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants aged 3 years of age or older
* Must currently be presenting with symptoms characteristic of pharyngitis, possibly Group A Strep, including:

  * Acute onset of sore throat;
  * Fever ≥ 37.8° C (100° F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8° C or feeling feverish within 24 hours of presentation and;
  * At least one of the following:

    * Red and swollen/inflamed tonsils (or fossae);
    * Pharyngeal or tonsillar exudate; o Cervical lymphadenopathy
* ≤ 14 days from onset of signs and symptoms of pharyngitis
* Parent/legal guardian of Participants \< 18 years of age capable and willing to give informed consent
* Participants ≥18 years of age capable and willing to give informed consent

Exclusion Criteria:

* Participants \< 3 years of age
* Participants undergoing treatment with antibiotics, or those who have undergone treatment with antibiotics for current episode of pharyngitis
* Currently enrolled in another clinical trial or used any investigational device within 30 days preceding informed consent
* Participants 18 years of age or older unable to understand English and consent to participation
* Parent/legal guardian of Participants \< 18 years of age unable to understand English and consent to participation of child
* Prior enrollment in this clinical validation study
Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)

Portal hypertension (PH) is one of the key drivers of clinical deteoration in patients with liver cirrhosis. It has been demonstrated that antiviral therapy in patients with chronic hepatitis C infection leads to a decrease of PH and is associated with an improved outcome. Recently, Bulevirtide was approved for the treatment of patients coinfected with hepatitis B (HBV) and chronic hepatitis delta (HDV) infection, which helps to achieve viral supression in these patients. This study investigates the potential effects of viral supression on PH in patients with chronic HBV/HDV infection and liver cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Chronic HBV/HDV Coinfection
* suspected or diagnosed liver cirrhosis, indication for hepatovenous pressure gradient (HVPG) measurement or liver cirrhosis and HVPG measurement conducted in the past 12 months (conducted prior to antiviral treatment)
* indication for antiviral treatment with Bulevirtide
* age \>18years
* Must be willing to participate in the study and provide written informed consent

Exclusion Criteria:

* patient rejects study participation
* no conducted or no indication for HVPG measurement
* age \<18years