cyrilzakka/clinical-trials huggingface dataset:
V501 Safety and Efficacy Study in Japanese Women Aged 16 to 26 Years (V501-110)

This study evaluated the long-term safety of quadrivalent Human Papillomavirus (HPV) types 6, 11, 16, 18 vaccine and its effectiveness in the prevention of cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ, and cervical cancer related to HPV in Japanese women.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese females
* Not pregnant at Screening and agree to use effective contraception through Month 7 of the study
* Lifetime history of 0 to 4 male or female sexual partners
* No oral temperature ≥37.5 centigrade within 24 hours prior to injection

Exclusion Criteria:

* Received a marketed HPV vaccine
* Prior abnormal Papanicolaou smear (PAP) or biopsy showing CIN
* Known history of positive test for HPV
* Known history of genital warts
* Received immune globulin or blood products within 6 months prior to first injection or plan to receive any through Month 7 of the study
* History of splenectomy, known immune disorders, or receiving immunosuppressives
* Immunocompromised or diagnosed as having human immunodeficiency virus (HIV)
The Effect of Liposuction on Menses: a Retrospective Study

The prevalence of obesity nearly tripled from 1975 to 2021, resulting in liposuction, as an effective shaping method, to be performed more frequently. Liposuction is a surgical procedure that uses a specialized instrument to suck fat fragments in the subcutaneous fat layer through a small incision. Analyzing a large sample sizes of patients who had liposuction, we found that some female patients underwent menstrual irregularity after liposuction. In 2004, Carolyn et al. reported several cases in which there was a connection between liposuction and an early onset of menses. Further studies showed that an early onset of menses may be related to the volume of adipose tissue extracted, the amount of anesthesia given, the area of liposuction, and body weight. However, the sample of that study was small, as there were only 17 cases included in the statistical model, and there are few articles in which the impact of liposuction on menses has been studied. To better understand whether menstrual irregularity will occur after liposuction, patients with postmenopausal or preoperative menstrual irregularity were excluded, leaving a sample of 518 female patients to be reviewed. A better understanding of the impact of liposuction on menses may help clinical doctors predict the underlying risk of menstrual irregularity after liposuction and identify individuals at higher risk. The findings may contribute to further understanding of menstrual irregularity.


Eligibility Criteria:
Inclusion Criteria:patients who were in 18-55 and have a regular menses -

Exclusion Criteria:Patients who were younger than 18 years old or older than 55 years old, who were in the perimenopausal or postmenopausal stage or who had menstrual irregularity before plastic surgery were excluded from both groups.

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Situation Awareness Incorporating Multidisciplinary Teams Reduce Arrests In the Pediatric ICU

The goal of this pragmatic prospective Type 1 Hybrid Implementation-Effectiveness Trial study is to learn if The Situation Awareness Incorporating Multidisciplinary Teams Reduce Arrests In (SAMURAI) the PICU Bundle can reduce PICU CPR events. The SAMURAI PICU Bundle includes an automated PICU warning tool, twice daily huddles and mitigation plans. The main questions it aims to answer are:

Is the adapted bundle will be acceptable, feasible, and appropriate to stakeholders prior to implementation?

Will there be at least a 30% relative reduction in PICU CPR events following successful implementation of the bundle?

Each site will:

Adapt and implement SAMURAI PICU Bundle which includes an automated PICU warning tool, twice daily huddles and mitigation plans

As nearly 95% of pediatric IHCAs occur in PICUs, we developed an interventional cardiac arrest prevention bundle targeted to PICU healthcare providers. In a previous single center trial, the use of the SAMURAI PICU bundle improved early identification of high-risk patients, increased shared situation awareness, and supported risk mitigation plans, leading to a \>50% decrease in IHCA events requiring cardiopulmonary resuscitation (CPR). Early identification occurs via the PICU Warning Tool, an automated, electronic medical record clinical decision support tool that provides a non-interruptive notification to care providers of high-risk patients. This prediction tool prompts a bedside huddle to ensure shared situation awareness and development of a mitigation plan. This novel approach of emphasizing shared situation awareness through automated clinical decision support and mitigation of risk has demonstrated reduction in CPR events and mortality within the PICU clinical environment.

This study employs a user-centered design model to adapt, implement, and assess the feasibility and effectiveness of SAMURAI PICU at other pediatric institutions. The hypothesis is that identification of PICU patients at high risk for IHCA through the use of the PICU Warning Tool and integration of this high-risk status in daily safety huddles will lead to improved shared situation awareness and subsequent reduction in CPR events at participating institutions. This approach will utilize a five-center pragmatic prospective Hybrid Type 1 effectiveness-implementation study leveraging the existing infrastructure of Pediatric Resuscitation Quality Collaborative (pediRES-Q).

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the five PICUs in pediRES-Q during the study period

Exclusion Criteria:

* None
Cognitive Motor Interference Rehabilitation in Persons With Multiple Sclerosis

This study examines the effect of balance and walking exercise on cognition and mobility in people with Multiple Sclerosis.

Walking and cognitive impairments are common in persons with multiple sclerosis (MS). Approximately 85% of persons with MS report walking as a major limitation, whereas 65% experience cognitive dysfunction. Traditionally, walking and cognition have been viewed as unrelated, but there is evidence of cognitive-motor interference (CMI). CMI is believed to stem from damage to common neural tracts. Recent evidence supports cognitive-motor interference in persons with MS. For example, there is evidence that walking performance declines when performed in conjunction with a simultaneous cognitive task (i.e., dual task cost \[DTC\] of walking) and this decline in walking performance is greater in persons with MS compared to healthy controls. This elevated cognitive-motor interference during walking is mainly associated with walking performance in persons with MS although cognitive function does play a role. Cognitive-motor interference during mobility tasks is of practical and clinical importance because it has been linked to decreased community mobility and a greater risk of falls in other clinical populations. Despite the adverse consequences of elevated CMI there is ambiguity concerning prevention and rehabilitation strategies for cognitive-motor interference in individuals with MS.

This study seeks to examine whether single and/or targeted dual task rehabilitation has a beneficial effect on CMI in individuals with MS. The results of this investigation will provide the foundation for future rehabilitation-based randomized control trials seeking to improve walking and cognitive function in persons with MS.

Eligibility Criteria:
Inclusion Criteria:Physician diagnosed MS, relapse free for 30 days, self reporting problems with multitasking -

Exclusion Criteria:We will exclude all individuals with risk factors contra-indicative for undertaking strenuous exercise. Participants will verbally respond to a health history questionnaire. Those individuals who are asymptomatic and meet no more than one risk factor threshold including family history of coronary heart disease, cigarette smoking, hypertension, high cholesterol, diabetes, obesity, and sedentary lifestyle will be considered at low risk and included for participation.

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Between Geriatric Syndrome and Chronic Disease Association and Prevalence Among Nonagenarians

OBJECTİVE The world population is getting older. The most common condition in the aging population is comorbidity, which is a combination of more than one chronic disease or condition. Contrary to the traditional view that specific symptoms are characteristic of a single disease, the coexistence of multiple diseases and other age-related conditions in elderly individuals leads to what is defined as geriatric syndromes. Geriatric syndromes are quite common in the elderly population and are associated with poor quality of life, adverse health status, and increased cost. Physicians who more frequently care and manage patients with comorbid diseases and geriatric syndrome can cope better with these conditions when faced with them. It is known that the frequency of comorbidity and geriatric syndrome increases especially in the elderly. However, in the oldest age group, which is showing the fastest increase in population, these rates are not clearly known. The aim of this study is to shed light on the management of elderly patients by identifying geriatric syndromes and comorbidity prevalence, as well as chronic diseases and common geriatric syndromes, in patients 90 years of age and older who applied to the geriatric outpatient clinic.

METHOD Data of patients 90 years and older who applied to the geriatric outpatient clinic between November 2016 and January 2020 were retrospectively analyzed. The drugs used by the patients with their demographic characteristics such as age, gender, chronic diseases and geriatric syndromes were gathered. The drugs used were also obtained from the hospital-registered files and through the E-Pulse health system. Diabetes mellitus (DM), hypertension (HT), cardiovascular diseases (CVD), cerebrovascular occlusion (CVO), chronic obstructive pulmonary disease (COPD), chronic kidney disease (CKD) were recorded as chronic diseases. Mild cognitive impairment (MCI), dementia, delirium, depression, fall, incontinence, malnutrition, sleep disorders, polypharmacy, and fall were recorded as geriatric syndrome. The modified Charlson comorbidity index was used to calculate the comorbidity index.


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling individuals aged 90 and over

Exclusion Criteria:

* Patients with missing data were excluded from the study
Effect and Safety of Smart Bra (PUMCH)

This is a multicenter, prospective clinical study was conducted to evaluate the safety and effectiveness of Xiehe smart bra for breast disease screening in outpatients with breast surgery. According to the patients' wishes and written informed consent, they were randomly assigned to the study group. A total of 2000 patients were expected to be enrolled. The training group: validation group = 1:1.

This study is a randomized, open, multicenter clinical study. It will be conducted in Peking Union Medical College Hospital, Shanxi Provincial People's Hospital, Beijing Third Hospital, Zhalantun ZhongMeng hospital, Chongqing Medical University affiliated university town hospital, Shenzhen People's Hospital and other national hospitals. A total of 2000 subjects are expected to participate. The patients in the group wore the device for about 3 minutes, and took photos of 5 breast sites. After that, the artificial intelligence learning was carried out on the photos of the training group. For the photos of the verification group, the algorithm obtained by the training group was compared with the existing artificial intelligence algorithms of ultrasound and molybdenum target. During the follow-up, the safety of the product was evaluated. According to the basic principles of safety and performance of who international general GHTF (sg1-n020r5) medical devices.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are going to receive breast ultrasound and molybdenum target in breast surgery clinic;
2. Female patients (18-80 years old);
3. Signed written informed consent approved by the relevant institutional review board (IRB) or independent ethics committee (IEC)

Exclusion Criteria:

1. The subjects were pregnant or lactating;
2. Patients with nipple discharge;
3. Known allergy to bra materials;
4. The patients who had received breast surgery or breast puncture within half a year;
5. Patients with skin diseases.
Healing Effect of Ziziphus Honey on Extracted Tooth Socket in Humans by Evaluating the Levels of BMP-2 and OPN

Ziziphus honey can improve bone healing at extracted tooth sockets in humans by increasing salivary levels of bone markers, OPN and BMP-2.

objectives of study: To study the effects of ziziphus honey on bone healing of extracted tooth socket in humans by comparing 1) Levels of BMP-2 and OPN in experimental and control groups at different intervals and 2) By radiographically measuring RBD of extraction sockets in experimental and control groups.

Aim of study: Post extraction ridge resorption is a major concern for future tooth prosthesis or implant placement. Honey can possibly help to improve bone healing and minimize ridge resorption after extractions.

Materials and Methods: Randomized controlled trial with simple random sampling of healthy individuals will be done. Total number of 30 participants will be equally divided into experimental group and control group. After tooth extractions in both groups, ziziphus honey will be injected into extracted sockets of experimental group while control group will be left as it is. Levels of BMP-2 and OPN will be tested in saliva through ELISA technique at day 0, 3 and 7 of tooth extraction and RBD will be measured on periapical radiographs at day 3, 21 and 40 in both groups.

Keywords: Bone morphogenetic protein-2 (BMP-2), Osteopontin (OPN), Relative bone density (RBD), Enzyme linked immunosorbent assay (ELISA).

Eligibility Criteria:
Inclusion Criteria:

1. Healthy patients of either gender with adult age
2. No known hypersensitivity to honey.
3. Permanent maxillary or mandibular molars (first or second molars)

Exclusion Criteria:

1. History of radiotherapy or chemotherapy
2. Diabetic and hypertensive patients.
3. Pregnant and lactating females.
4. Smoking or consumption of alcohol
5. Bone conditions like osteoporosis etc.
6. Patients on oral contraceptives or steroid therapy
7. Subjects taking antibiotics or NSAIDS within one week.
Intensity-modulated Radiation Therapy From 70Gy to 80Gy in Localized Prostate Cancer

The objective is to report outcomes,including grade ≥2 overall late rectal and urinary toxicity and biochemical control rates in patients treated with IMRT (70 gy, 74 Gy and 80 Gy)


Eligibility Criteria:
Inclusion Criteria:

Consecutive patients from June 2000 to December 2010 with

* untreated histologically confirmed adenocarcinoma of the prostate
* stage T1c-T4 N0 M0 according to the 1992 American Joint Committee on Cancer staging system

Exclusion Criteria:

* Patients with positive pelvic lymphadenectomy or radiological positives nodes
Representation of Congenital Birthmarks

This descriptive cross-sectional single center study will be conducted at Angers Maternity Unit.

It pertains to the ways in which healthcare professionals represent congenital birthmarks found in newborns.

It is our assumption that health professionals may have a tendency to engage in inappropriate behavior when dealing with congenital birthmarks due to lack of knowledge. We make the presumption that insufficient knowledge causes difficulties in managing these birthmarks.

Data as to representation of birthmarks in newborns by health professionals will be collected using a semi-quantitative questionnaire.

This study constitutes preliminary research work, with a view to creating a professional development plan if necessary.

This descriptive cross-sectional observational study will take place at a single center: Angers Hospital Maternity Unit.

Our aim is to assess how healthcare professionals represent congenital birthmarks in newborn infants.

We intend to use an optional anonymous questionnaire that will be placed strategically in Angers Maternity Unit workspaces . Each health professional from Angers Maternity Unit will be asked to complete this questionnaire.

In this five-minute questionnaire, they will be asked questions regarding their representation of congenital birthmarks, their feelings and their knowledge.

We make the hypothesis that some health professionals lack knowledge and are uncomfortable with managing these birthmarks and providing explanations to the parents of newborn infants. We also show them some examples of birthmarks, prompting them to express any feelings they may have.

This questionnaire was co-written by Pauline VABRES, a psychologist with experience in the field of self-representation.

The questionnaire will remain accessible for 45 days, ensuring that every Maternity Unit health professional has the opportunity to participate (approximately 140 people, excluding non-health professionals working in the Maternity Unit and students).

On completion of the questionnaire, the healthcare professionals will seal their answers in envelopes to guarantee anonymity.

At the end of the 45-day period, the answers will be collected and analyzed.

If required, the second phase of this work will focus on developing educational interventions for health professionals to enhance their knowledge of congenital birthmarks. We also hope to improve management of these lesions and enhance the quality of the explanations provided to parents of newborns.

Previous studies have already addressed the feelings of parents confronted with congenital birthmarks. To our knowledge, this is the first study of its kind to evaluate the perspective of health professionals

Eligibility Criteria:
Inclusion Criteria

All health professionnals working at Angers Maternity Unit:

* Midwives
* Nursing auxiliaries
* Childcare assistants
* Gynecologists
* Residents
* Pediatricians

Exclusion Criteria:

* Refusal to participate
* Non-health professionals working at Angers Maternity Unit (hospital cleaners, hospital food workers)
* Students (trainee pediatricians, trainee gynecologists, trainee midwives)
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with advanced-stage idiopathic Parkinson's disease

This is the open-label extension to the randomized, double-blind, placebo-and active controlled SP515 (NCT00244387) trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease that were not well-controlled on levodopa

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed four months of maintenance treatment in the SP515 (NCT00244387) double-blind trial

Exclusion Criteria:

* Subjects who had an ongoing serious adverse event from SP515 (NCT00244387) double-blind trial that was assessed as related to study medication
Feasibility and Impact of Online HIV/STI Screening Addressed to PrEP Users in Spain

Non-blinded randomized controlled non-inferiority trial to evaluate the feasibility, acceptability and impact of an innovative internet-accessed HIV and STIs screening intervention (TÉSTATE PrEP) addressed to gays, bisexuals and other men who have sex with men (GBMSM) and transgender women users of PrEP in Spain as part of PrEP follow up.

The objectives of the study are 1) To design and implement an e-HIV/STI testing pilot intervention (TÉSTATE PrEP) to offer self-sampling kits to detect HIV, Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Treponema pallidum (TP) among gays, bisexuals and other men who have sex with men (GBMSM) and transgender women users of pre-exposure prophylaxis (PrEP) as part of PrEP follow up. 2) To evaluate if the pilot does not cause a reduction of the retention to PrEP follow up among the target population. 3) To analyze the capacity of the intervention to reduce the healthcare burden of the PrEP service. 4) To evaluate the acceptability of the intervention among PrEP users and healthcare workers of the PrEP services; and 5) To validate dried blood samples (DBS) for confirmation of TP infection and performing RPR to determine stage and activity of infection comparing with blood drawn by venous puncture. Investigators will perform a non-blinded randomized controlled non-inferiority trial among PrEP users on follow up in one of the main PrEP services of Spain. Participants on the control arm will follow the usual follow up protocol with quarterly face-to-face visits where they will be tested for HIV and STIs. Participants in the experimental arm will alternate face-to-face meetings with online screening of HIV and STIs. This project is based on the TÉSTATE project (PI17 00355). The website https://testate.org/ will include a module for online follow-up visits of participants on PrEP. Participants of the experimental arm will register in the website and will receive self-sampling kits to their home to get tested for HIV, CT, NG and TP. Participants will send the samples to the reference laboratory and check their results online. The investigators will compare the retention to follow up among PrEP users in the control and experimental arm and the healthcare burden in each group. The acceptability of the intervention among the PrEP users and healthcare workers will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* GBMSM or transgender women
* PrEP users with more than 1 year of follow up in the collaborating center (The Centre for International Health and Infectious Diseases Drassanes Vall d'Hebron (Barcelona))
* Not having altered renal function
* Resident in Spain

Exclusion Criteria:

* Not able to read in Spanish
* Not able to give their consent
Evaluating Thermal Ablation in the Treatment of Cervical Neoplasia

Longitudinal study in Burundi to evaluate the effectiveness, the acceptability and safety of thermal ablation in the treatment of cervical neoplasia.

The study population consisted of women with an abnormal VIA test or an abnormal colposcopy examination. A total of 86 women with lesions eligible to ablative treatment were counselled and treated by thermal ablation. Informed consent was signed by each participant. Just after treatment, they were inquired about the level of pain during the procedure, and their level of satisfaction with the treatment. They were followed-up at 6 weeks for any complication and re-assessed by VIA and colposcopy at 12 months for any persistent or recurrent lesion and for any adverse event.

Eligibility Criteria:
Inclusion Criteria:

* Women residing in Burundi and referred to the tertiary hospital after a positive VIA test

Exclusion Criteria:

* Lesion occupying the 4 quadrants of the cervix
* Not visible squamous columnar junction (not Type 1 TZ)
* Vaginal or endocervical lesion
* Lesion subjective of cervical cancer
Register for Pediatric Patients With Antiphospholipid Syndrome (APS): European Project Extended Internationally Study

The purpose of this study is to gather information about causes and treatment of Antiphospholipid Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or younger at the onset of disease
* Presence of Vascular Thrombosis
* UC Davis patient
* Presence of at least one Laboratory criteria including: Anticardiolipin antibody, Anti-B glycoprotein-I antibody or Lupus anticoagulant in plasma

Exclusion Criteria:

* Infants born to mothers with APS
* Infants with congenital thrombophilia