cyrilzakka/clinical-trials huggingface dataset:
Human Papilloma Virus Infection in HIV-Positive Indian Men Who Have Sex With Men

RATIONALE: Gathering information about human papilloma virus (HPV) infection in HIV-positive men who have sex with men may help doctors learn more about the disease.

PURPOSE: This clinical trial is studying HPV infection in HIV-positive Indian men who have sex with men.

OBJECTIVES:

* Describe the prevalence of penile, anal, and oral human papilloma virus (HPV) infection in HIV-seropositive Indian men who have sex with men.
* Determine the spectrum of HPV types at these anatomic sites in these patients.
* Determine the distribution of strain variants of HPV 16, 18, and 31 at these anatomic sites in these patients.
* Describe risk factors for penile, anal, and oral HPV infection in these patients.

OUTLINE: This is a multicenter study.

Patients complete interviewer-administered questionnaires on demographics, native place, socioeconomic status, medical history, numbers of sexual partners and sexual practices, circumcision status, and risk factors for oral malignancies and human papilloma virus (HPV), including oral sex, smoking or chewing tobacco, drug use, oral hygiene, and tooth loss.

Patients undergo cell sample collection from the penis, scrotum, anus, and mouth, and saliva sample collection for HPV DNA testing by PCR. Patients also undergo blood sample collection to measure CD4+ count and HIV viral load by FACS and PCR.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* HIV-1 infection, as documented by ELISA and confirmed by a second testing method (e.g., western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA)

  - If prior documentation and confirmation of HIV-1 infection is not available, two licensed rapid HIV tests are allowed
* Must have had receptive or insertive anal intercourse with another man within the past 6 months

PATIENT CHARACTERISTICS:

* Speaks Hindi (in Mumbai) or Tamil (in Vellore)
* No active drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements
* No history of a sex-change operation that would preclude collection of penile or scrotal specimens

PRIOR CONCURRENT THERAPY:

* Not specified
Strengthening Healthy Relationships Among Apsaalooke Youth

This pilot project proposes to build upon these cultural strengths, including the clan system, to test the feasibility of a translational research intervention to promote healthy relationships and prevent dating violence among Apsáalooke youth. Community Advisory Board members identified 5th grade as an important age to establish healthy dating norms. The feasibility study includes a one-group pre/post intervention that includes 10-hour long sessions with youth to promote healthy relationship knowledge, volition, and communication skills. Elders and near-peer (young adults) will assist during these sessions sharing advice and serving as role models for youth. In addition, to promote the connectedness between youth and their community, there are 3 monthly clan feeds.

This project builds upon long-standing community-based participatory research partnerships between Montana State University and the Crow Nation. Through these partnerships, Apsáalooke community members prioritized healthy relationships among youth as a critical area for intervention. Through interviews and focus groups with Apsaalooke community members a strength-based strategy to promote healthy relationships among youth has emerged. This pilot project proposes to build upon these cultural strengths, including the clan system, to test the feasibility of a translational research intervention to promote healthy relationships and prevent dating violence among Apsáalooke youth. Community Advisory Board members identified 5th grade as an important age to establish healthy dating norms. The feasibility study includes a one-group pre/post intervention that includes 10-hour long sessions with youth to promote healthy relationship knowledge, volition, and communication skills. Elders and near-peer (young adults) will assist during these sessions sharing advice and serving as role models for youth. In addition, to promote the connectedness between youth and their community, there are 3 monthly clan feeds. Using a participatory approach, our project will accomplish the following aims:

1. Using a participatory research approach, finish adapting and localizing the curriculum. 2. Test the feasibility of pilot intervention among Apsáalooke youth and their families. 3. Refine pilot intervention and design an appropriate translational intervention (R01) for promoting healthy relationship skills among Apsáalooke youth.

Eligibility Criteria:
Inclusion Criteria:

* Youth residing on or near the Crow Reservation 5th grade

Exclusion Criteria:

* Those without parental consent
Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents

We aim to include 60 children and adolescents aged 10 to 19 years who have undergone successful treatment for leukemia or lymphoma. Based on randomization, they will either 1) commence 16 weeks of training with STEEL or 2) commence 16 weeks of circuit training. STEEL training involves exercises for major muscle groups using free weights, body weight, or tailored machines. Circuit training is structured similarly to previous training for the target group and includes exercises using body weight, exercise balls, and rings. The training takes place in local centers either with friends or with other participants in the project. Before starting participation in the project, the child/adolescent and their parents or guardians will receive information about late effects, diet, sleep, and exercise, providing guidance and support regarding the project elements. The effects of the two training modalities will be evaluated based on self-reported quality of life, muscle strength, muscle mass, bone mineral content, fitness, and markers of metabolic syndrome (BMI, waist circumference, blood pressure, and blood analysis).

The trial is designed as a national randomised clinical trial. Participants will be stratified by sex and block randomised (block sizes of 2 to 6) at 1:1 to either STEEL or the circuit training programme. A researcher not involved in the trial will generate the allocation sequence using a random number generator and is the only person who will know the block sizes. The study will be conducted at Aalborg University Hospital, Rigshospitalet, Odense University Hospital, and Aarhus University Hospital and was designed in collaboration with parents of childhood cancer survivors and an adult childhood cancer survivor suffering from late effects. Participants must attend three examinations at their respective hospitals: baseline and after 8 and 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Ten to 19 years of age at the point of inclusion
* A minimum of 12 months since the last chemotherapy with no upper limit
* Ability to understand the physical intervention and general participant advice

Exclusion Criteria:

* Participation in another research study that includes similar treatment
* Pregnancy
* Cardiac arrhythmia during exercise
* Psychological disorders interfering with treatment
* Presence of a clinical condition that needs immediate treatment
* Planned surgeries within the subsequent 12 months that may interfere with performing exercises
* Any contraindications to performing physical exercise as evaluated by the recruiting medical doctor
Analgesic Ear Drops for Children With Acute Otitis Media

This trial aims to investigate whether analgesic ear drops added to usual care provide superior ear pain relief over usual care alone in children presenting to primary care with AOM. Children will be randomly allocated (ratio 1:1) to either 1) lidocaine hydrochloride 5mg/g ear drops (Otalgan) 1-2 drops up to six times daily for a maximum of 7 days in addition to usual care (oral analgesics, with/without antibiotics) or 2) usual care. Parents will complete a symptom diary for 4 weeks as well as generic and disease-specific quality of life questionnaires at baseline and 4 weeks. The primary outcome is the parent-reported ear pain score (0-10) over the first 3 days.

NOTE:

At the time of publication of the study protocol paper, the investigators were unable to make any amendments to the trial registration record in the Netherlands Trial Register (NTR) (NL9500; date of registration: 28 May 2021). The addition of a data sharing plan was required to adhere to the International Committee of Medical Journal Editors (ICMJE) guidelines. The investigators therefore re-registered the trial in ClinicalTrials.gov. This second registration is for modification purposes only and the NTR record (NL9500) should be regarded as the primary trial registration.


Eligibility Criteria:
Inclusion Criteria:

* Age 1 to 6 years
* Parent-reported ear pain in 24 hours prior to enrolment
* GP-diagnosis of (uni- or bilateral) AOM

Exclusion Criteria:

* with (suspected) tympanic membrane perforation or ventilation tubes
* with ear wax obscuring visualisation of the tympanic membrane
* who are systemically very unwell or require hospital admission (e.g. child has signs and symptoms of serious illness and/or complications such as mastoiditis/meningitis)
* who are at high risk of serious complications including children with known immunodeficiency other than partial IgA or IgG2 deficiencies, craniofacial malformation including cleft palate, Down syndrome and previous ear surgery (with the exception of ventilation tubes in the past)
* who have a known allergy or sensitivity to study medication or similar substances (e.g. other amide-type anaesthetics: bupivacaine, mepivacaine, prilocaine, etc)
* who have taken part in any research involving medicines within the last 90 days, or any other AOM-related research within the last 30 days
* who suffer from chronic recurrent pain of another origin than the ear
* who have participated in this trial during prior AOM episode
Main Study: A Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area Sub-study: A Follow-up Study to Evaluate the Analysis of Mammograms Following Treatment for Correction of Wrinkles in Décolletage Area in the Investigational Study 43USRV1906

Main study: Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GAL1906 for the correction of wrinkles in the décolletage area.

Sub-study: To evaluate imaging interpretation of mammograms in subjects who were enrolled and treated in the 43USRV1906 main study. The sub-study will determine if hyaluronic acid injections in the décolletage interfere with diagnosis or interpretation of mammogram results.


Eligibility Criteria:
Inclusion Criteria for Main study:

* Subjects willing to comply with the requirements of the study and providing a signed written informed consent.
* Non-pregnant, non-breastfeeding females, over the age of 21.
* Subjects seeking treatment for the décolletage.

Inclusion Criteria for Sub-study:

* Subject is willing to comply with the requirements of the study and provide a signed written informed consent.
* Subject has received treatment with GAL1906 in the main protocol.

Exclusion Criteria for Main study:

* Known/previous allergy or hypersensitivity to any injectable HA gel or to gram positive bacterial proteins.
* History of allergy or hypersensitivity to lidocaine or other amidetype anesthetics, or topical anesthetics or nerve blocking agents (if such products are intended to be used for that subject).

Exclusion Criteria for Sub-study:

• Subject is pregnant or nursing AND has no mammogram taken post GAL1906 treatment.
Impact of a Multidimensional Intervention in Elderly Patients With Pneumonia

The hypothesis of this study is that long-term outcome in elderly patients admitted with the diagnosis of community-acquired pneumonia (CAP) or healthcare-associated pneumonia (HCAP) would improve with a multidimensional intervention including assessment of co-morbidities, nutritional, functional and cognitive status and immunization.

Detailed description published in "Revista Española de Geriatría y Gerontología" (see citation and link)

Eligibility Criteria:
Inclusion Criteria:

* Elderly patients (aged 65 years and over), of either sex, not dependent for basic activities of daily living (Barthel index ≥60 points).
* Diagnosed with community-acquired pneumonia at the Emergency Department or Day Hospitals at "Hospital de la Santa Creu I Santa Pau"
* Admitted to hospital.

Exclusion Criteria:

* Derived from other acute care hospitals.
* Patients with HIV infection.
* Neutrophil counter\<1000/mm3
* Transplanted patients.
* Barthel index\<60 points.
* Terminal disease.
* No signed informed consent.
Comparison of Perineural Catheter Depth for the Continuous Popliteal Nerve Block Using Ultrasound Guidance and Dermabond

The study will investigate the difference in success rate between popliteal peripheral nerve catheters placed at 1 centimeter compared to 5 centimeters past the tip of a Tuohy needle.

Traditionally for the lower extremity, peripheral nerve catheters have been threaded greater than or equal to 5 centimeters past the tip of the Tuohy needle. The major rational for this practice is to reduce dislodgement. However, the greater the distance that a catheter is advanced, the greater the risk of contacting undesired structures, kinking, looping and knotting. For the continuous popliteal nerve block, the catheter is threaded perpendicular to the course of the nerve. This could result in the tip of the catheter being a significant distance from the targeted nerve which may lead to a decrease in the success rate or efficacy of the block.

Greater efficacy may be seen if the needle is closer to its target. This may be quantified by documenting a faster onset of motor and sensory changes and/or a lower catheter infusion rate required to maintain pain control. The study will investigate the difference in success rate between popliteal peripheral nerve catheters placed at 1 centimeter compared to 5 centimeters past the tip of a Tuohy needle.

Eligibility Criteria:
Inclusion Criteria:

* Will be having a popliteal nerve blocks
* Do not meet any of the exclusion criteria listed below.

Exclusion Criteria:

* \< 18 years old
* BMI \> 35
* Pregnant patients
* Diabetes mellitus or patients with known neuropathy
* Amputations \& polytrauma patients
* Patients allergic to local anesthetics
* Chronic Pain patients
* Patients in whom communication is a problem
A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% 2 Times Daily (BID) and Bromfenac 0.09% 2 Times Daily (BID)

Approximately 50 patients undergoing cataract surgery will be randomized in an even allocation (1:1) into two treatment groups, either ketorolac 0.45% BID or bromfenac 0.09% BID. Patients will be instructed to begin dosing study medication in the operative eye the day before surgery and continue dosing until day 14. KOWA flare measurements will be performed at postoperative day one and postoperative day 14. The amount of anterior chamber inflammation (flare) will be objectively measured.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 18 years of age or older
* Scheduled for cataract surgery by phacoemulsification
* Subject must be willing to comply with all study requirements and be willing to give informed consent

Exclusion Criteria:

* Any subject that has a history of uveitis or active iritis
* Subject can have no previous intraocular surgery with the exception of refractive surgery. but not within 6 months
* No ocular use of prostaglandins within 2 weeks of surgery
* Use of oral, injectable or topical steroids,nonsteroidal anti-inflammatory drugs (NSAIDs) or immunosuppressants within 14 days prior to surgery
* Contraindications to NSAIDs
* Active ocular infection
Imaging of Vitreous Opacities in Human Eyes

Vitreous opacities (VOs), commonly known as floaters, are dark spots that appear in, and may float across your vision. Presently, there is a lack of available data in the literature regarding VOs. This study aims to obtain imaging data of VOs in the population to build an imaging database of VOs to learn more about them.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* SVO-related symptoms in vision
* Clear ocular media, to allow a clear view of the vitreous for the SVO-ID

Exclusion Criteria:

* Presence of vitreous hemorrhage
* Cataract Grade 3 and above
* Opacification of lens, cornea, or vitreous
* Diagnosis of narrow-angle glaucoma
* Refractive error is outside the range of -6D to +3D
* Astigmatism is outside the range of +/- 2D of cylinder
Follow-up of the Cardiomyopathy Cohort SFB/TR19

Follow-up of a cohort of inflammatory cardiomyopathy patients (suspected or validated inflammatory cardiomyopathy) recruited at baseline by the SFB-TR19 project. Standardized protocols will be used for the assessment of medical history and examinations, laboratory biomarkers, and the collection of various biomaterials for biobanking purposes.

Periodical follow-up of a cohort of inflammatory cardiomyopathy patients (suspected or validated inflammatory cardiomyopathy) recruited at baseline by the SFB/TR19 project. Participants will be followed up at least every year - or more frequently based on clinical need. Standardized protocols will be used for the assessment of medical history and examinations, laboratory biomarkers, and the collection of various biomaterials for biobanking purposes.

Eligibility Criteria:
Inclusion Criteria:

* Participation in baseline examination of SFB/TR19

Exclusion Criteria:

* none
Reirradiation With Concomitant Chemotherapy After Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area

Interest of a reirradiation with concomitant chemotherapy after salvage surgery for recurrence of head and cancer in irradiated area : a multicentric Phase III randomized trial


Eligibility Criteria:
Inclusion Criteria:

* head and neck squamous cancer
* both sexes
* \>=18 years
* recurrence treated by surgery and initially treated by radiotherapy
* with written informed consent at entry time

Exclusion Criteria:

-
Evaluation of Post Infectious Inflammatory Reaction (PIIR) Concerning Children After Streptococcus Pneumoniae, Streptococcus Pyogenes and Neisseria Meningococcus Invasive Infection

As Covid 19 manifestations that have been recently described, inflammatory manifestation have major impact in infectious disease lesions. Some of them are delayed and provide Post infectious inflammatory reaction (PIIR), they are challenging for diagnosis and for management. Clinician have to avoid unnecessary antibiotic thearapy and in if necessary have to give immunosuppressive therapy. Except for rheumatic disease for group A streptococcus (GAS) infections there are not stanrdized diagnostic criteria and therapeutic protocol, and PIIR have probably a suboptimal management. In this context the investigators aim to explore PIIR in the 3 most frequent bacterial invasive infection in France, by a retrospective monocentric study. The investigators include all children betwwen 2012 and 2018 hospitalized for infections by Streptococcus pneumoniae (SP), Neisseria meningitidis (NM), and GAS invasive infections.


Eligibility Criteria:
Inclusion criteria:

* Less than 18 years of age
* Fever associated with GAS, NM, or SP invasive infection

Exclusion criteria:

* age \> 18 years
* Impossibility to obtain the consent of parents / legal representatives.
Dexmedetomidine for LISA Procedure in Preterm Infants

The investigators aim to evaluate: the effectiveness of dexmedetomidine for analgesia and sedation during LISA procedure, without compromising the respiratory drive; the safety of this drug on the preterm infant in a pilot study.

Information will be given to parents of preterm babies \<36 wGA upon their admission to the NICU (neonatal intensive care unit), and informed consent will be obtained as soon as possible. Eligible babies for LISA procedure (dyspneic and FiO2 \> 0.30 on CPAP pressure of at least 6 cmH2O) undergo sedation with dexmedetomidine 1 mcg/kg, administered slowly iv in 10 minutes, together with non pharmacological techniques. After the step of sedation LISA is performed. Before/during and after the procedure pain will be assessed by the NIPS scale and the quality of intubation will be evaluated; then other events related to the procedure will be strictly collected for the first 24 hours. Babies will then be managed in usual NICU way and clinical data will be unregistered on respiratory, neurological and hemodynamic outcomes during the hospital stay, and especially at discharge.

Eligibility Criteria:
Inclusion Criteria:

1. Preterm newborns between 26+0 and 36+6 weeks of gestation stratified in two groups: VLBWI 26-31+6and LBWI 32-36+6.
2. Respiratory distress syndrome requiring surfactant therapy

Exclusion Criteria:

1. Need for emergency intubation in the delivery room
2. Major congenital malformations (such as cardiopathies)
3. Chromosomic abnormalities
4. Fetal Hydrops
5. Hypercapnia: CO2 \> 65 mmHg
6. Pneumothorax
7. Hemodynamic compromise
Does Disinfection of the Subcutaneous Tissue Reduce Contamination of the Operating Field With P. Acnes?

Propionibacterium acnes is a pathogen commonly identified in postoperative shoulder infections. A recent study has shown that P. acnes is likely to be disseminated in the operating field from the subcutaneous layer by the manipulation of soft tissues by the surgeon and the instruments. Disinfection of the subcutaneous tissue seems to significantly reduce contamination of the operating field during primary shoulder surgery. This study seeks to assess the efficacy of disinfection of the subcutaneous tissue compared to dissection with an electrosurgical unit on P. acnes contamination during primary shoulder surgery.

The investigators are going to study the efficacy of disinfecting the subcutaneous tissue with Betadine standard solution during primary shoulder surgery compared to electrosurgical dissection. They will randomize 105 patients on two arms. The control group receiving no disinfection of the subcutaneous tissue but a dissection with an electric cautery(A) and intervention group receiving a disinfection of the subcutaneous tissue (B). They believe that the duration of 4 years is sufficient to recruit the number of patients necessary for this study.

All patients 18 years of age or older admitted to Valais Hospital for primary shoulder surgery and having signed the consent of the study will be eligible.

The use of disinfection of the subcutaneous tissue during primary shoulder surgery could reduce contamination of the operating field and theoretically the post-operative infection rate after primary shoulder surgery.

The study focuses on disinfection with Betadine solution of the subcutaneous tissue during primary shoulder surgery. This action could decrease contamination of the operating field and the infection rate after primary shoulder surgery.

This solution is already widely used for disinfecting the skin and traumatic or surgical wounds.

The investigators will use it according to the recommendations made in the Swiss Compendium of Medicines.

No evidence has been brought to a decrease in this contamination if the dissection is carried out with an electric cautery. Scalpel dissection is used as standard in orthopedic surgery as well as in other surgical disciplines.

Eligibility Criteria:
Inclusion Criteria:

1. = or\> 18 years old
2. treated at the Valais Hospital for primary shoulder surgery.
3. have signed the consent

Exclusion Criteria:

1. \<18 years old
2. History of shoulder surgery
3. History of shoulder infection
4. Antibiotic therapy in the 2 weeks preceding the intervention
5. Cortisone infiltration in the 6 months preceding the intervention
6. Allergy to iodinated contrast agent or Cefuroxime
7. Allergy to povidone iodine complex or other contraadication to Betadine
8. Refusal of study terms