cyrilzakka/clinical-trials huggingface dataset:
5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa

This is a single arm study on the safety, feasibility, and acceptability of adjuvant, self-administered, intravaginal 5-Fluorouracil (5-FU) following treatment for high-grade cervical precancer (CIN2/3) among women living with human immunodeficiency virus (HIV).


Eligibility Criteria:
Subjects must meet all of the inclusion criteria to participate in this study.

Inclusion Criteria:

1. HIV-positive women
2. Age 18 years - 49 years at enrollment
3. Documentation of a biopsy-confirmed CIN2 or CIN3
4. Within 4-12 weeks after primary treatment for CIN2 or CIN3
5. Negative pregnancy test at screening and agreement to use dual form of contraception (hormonal birth control, intrauterine device, or tubal ligation - plus condoms) during the study duration, if of childbearing age.
6. Agree to use dual contraception if of childbearing age (hormonal method, intrauterine or implant device, or tubal ligation - plus condoms) for duration of study
7. Ability to understand and willingness to sign (or assent when applicable) informed consent

Exclusion Criteria:

1. HIV-negative women
2. Pregnant or planning pregnancy within the next 6 months or breastfeeding
3. Unwilling or unable to use birth control during participation in the study
4. History of invasive cervical cancer
5. Untreated vaginal or vulvar dysplasia
6. Known allergy to 5-Fluorouracil
7. History of total hysterectomy
8. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient
9. Current use of chemotherapeutic medication or high dose steroids (10 mg prednisone per day or more (or equivalent steroids)
Correlation Between Smart Phone Overuse, Craniovertebral Angle, Cervical Muscle Endurance and Temporomandibular Proprioception in Adolescents

The study was done to:

1. Investigate the correlation between smart phone overuse and craniovertebral angle in adolescents.
2. Investigate the correlation between smart phone overuse and cervical muscle endurance in adolescents.
3. Investigate the correlation between smart phone overuse and temporomandibular joint proprioception in adolescents.

This study was aimed to clarify the correlation between prolonged use of spinal traction on cervical curvature, muscle endurance, and temporomandibular joint proprioception in adolescents. It assisted physiotherapists in detecting and treating problems caused by prolonged spinal traction use, providing necessary precautions and treatments to prevent or alleviate this issue.

Eligibility Criteria:
Inclusion Criteria:

1. Both genders will be included.
2. Adolescents with age ranging from 17 to 19 years.
3. Adolescents using smart phone daily for not less than 4 years for 4 years.
4. All participants will be free from any medical disease, visual or hearing problem.
5. No history of temporomandibular joint complaints or disorder.

Exclusion Criteria:

1. Adolescent who cannot understand or follow instructions.
2. Congenital or acquired spinal deformities.
3. Adolescents with obesity.
4. Athlete adolescents.
5. Any neck or upper extremity Injury.
6. Neurological, musculoskeletal, and cardiopulmonary disease.
7. Adolescent with teeth braces during last 4 years
High Supracostal Versus Subcostal Puncture in Adult PCNL

as the supra eleventh puncture PCNL is not well investigated in the literature we will conduct that randomised trial in comparison to the subcostal one

The use of percutaneous nephrolithotomy (PCNL) was first reported by Fernström and Johansson in 1976. Percutaneous nephrolithotomy (PCNL) is the accepted treatment for staghorn stones, large renal stones, and some upper ureteric stones. Achieving suitable access to the appropriate calyx is one of the most important steps during the PCNL procedure. Effective puncture is key for the success of PCNL. An ideal percutaneous nephrolithotomy (PCNL) puncture has been described as one that provides the shortest and straightest access to all calculi, avoids major vessels, bowel and lung, lies along the axis of the calyx and causes minimal parenchymal damage.

Many studies have reported that supracostal access for PCNL is advantageous over infracostal access. By creating a straight path along the kidney's long axis, the upper-pole method guarantees access to the majority of the collecting system and makes it simpler to manipulate the rigid nephroscope and other rigid devices. Therefore, supracostal puncture is perhaps the greatest method for gaining access to the upper pole calyx, where staghorn and big, complicated renal stones are most likely to be located. Although pneumothorax, hydrothorax, and lung damage (1-10%) can result after a supracostal puncture, this injury can now be handled with minimal morbidity thanks to advances in surgical technique and understanding of pleural and diaphragmatic architecture.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* Patients amenable for PCNL with stone burden between 2 cm - 4 cm (guy score 1-2-3)

Exclusion Criteria:

* Ectopic kidney.
* Single middle calyceal stone.
* Skeletal anomalies.
* Bleeding diathesis.
* Active urinary tract infection.
* Patient refusing participation.
* Patients with active pulmonary and pleural disease.
Prevalence of Dissociative Identity Disorder in At-risk Outpatient Groups Reporting Childhood Trauma.

The investigators will study the prevalence of dissociative identity disorder (DID) in three populations at risk in cases of childhood psychotrauma : patients with a diagnosis of borderline personality, patients with a diagnosis of functional dissociative crises (FDC) and patients with early psychosis.

The investigators will also study the prevalence of other dissociative disorders and the frequency of complex post-traumatic stress disorder.

The investigators will also look for correlations between the type of maltreatment in childhood, the age of onset of trauma and the type of diagnosis of dissociative disorders.

The investigators hope to include 150 borderline patients, 150 FDC patients and 50 early psychosis patients.

Data collection will be done via a psychometric administration of 7 self-completion questionnaires as well as the completion of the SCID-D semi-structured interview.


Eligibility Criteria:
I - Inclusion Criteria:

I-1: For all groups:

* Male or female
* Age \> or = 18
* Enrolled in or benefiting from a social security scheme
* Patient fluent in French
* Patient willing to undergo a psychological evaluation between 1h30 and 3h30
* Patient with a known history of psychotrauma in childhood before the age of 18 (sexual abuse, mistreatment, school harassment, natural disasters, attacks, etc.).
* Patient having received and understood complete information on the organization of the research and having given written free and informed consent prior to participation in the study.

I-2 : Patients in the borderline group

* Patients with main diagnosis of emotionally labile personality
* Patients with at least one psychiatric hospitalization in the last 3 years

I-3 : Patients in the early psychosis group

Patient with a diagnosis of mental state at risk of psychosis according to the criteria defined by CAARMS (Comprehensive Assessment of At Risk Mental State) OR Patients diagnosed with a first psychotic episode on an outpatient basis or following a hospital stay

I-4 : Patients in the functional dissociative crises group

Patients diagnosed with functional dissociative crises by a specialized epileptologist

II- Non-inclusion criteria

* Impairment of the subject making it difficult or not impossible to participate in the trial or to understand the information provided to him/her
* Patients with specific difficulties in understanding SCID-D questions
* Psychiatric condition requiring hospitalization
* Patients with symptoms of recent toxic consumption (alcohol, cannabis, other ...) disrupting assessment responses
* Patient taking part in a pharmacological study involving a pro-dissociative molecule of the psychedelic type
* Pregnant, parturient or nursing mothers
* Person deprived of liberty by judicial or administrative decision
* Person in a life-threatening emergency
* An adult under legal protection (guardianship, curatorship, safeguard of justice)
* Person unable to give consent and not subject to a legal protection measure
Computerised Decision-Support Tool for Childhood Obesity Management

The objective of the present study was to examine the effectiveness of a computerised decision-support tool, developed to assist paediatric clinicians in delivering personalised nutrition and lifestyle optimization advice to children and their families, as a means of childhood obesity management.

The objective of the present study was to examine the effectiveness of a computerised decision-support tool, developed to assist paediatric clinicians in delivering personalised nutrition and lifestyle optimization advice to children and their families, as a means of childhood obesity management.

The effectiveness of the decision support tool was assessed through a pilot randomized controlled intervention trial (RCT). The RCT was initiated on May 2018 and was conducted in the Endocrinology Department of the "P. A. Kyriakou" Children's Hospital and in the Division of Endocrinology, Metabolism, and Diabetes of the "Aghia Sophia" Children's Hospital in Athens, Greece.

Sixty-five overweight or obese children that were eligible to participate in the RCT, were randomly and equally allocated to two study groups. Those children that were randomly allocated to the intervention group (IG), were examined by health professionals (i.e. paediatricians, paediatric endocrinologists and a dietitian) who were trained in the use of the decision support tool. The latter assisted the medical professionals to assess children's weight status, to set appropriate weight management goals and provide personalised meal plans and/or recommendations to children and their families. On the contrary, those children that were randomly allocated to the control group (CG) received the usual care advice that is routinely provided to children in the two hospitals and includes child visits and follow-up appointments for weight checks with their primary care provider or dietitian.

The effectiveness of the intervention was evaluated through the collection of data at baseline and at a follow-up examination after 3 months.

All data were uploaded to the decision-support tool, which analysed them and extracted a report with the child's assessment, as well as with personalised diet and lifestyle optimization recommendations. More specifically, the decision support tool proposed personalised weekly meal plans adjusted to the estimated energy requirements calculated for each child, as well as personalised diet and lifestyle optimization advice recommendations for the child and/or the entire family. Lastly, the decision support tool suggested a periodic re-evaluation every 3 or 6 months depending on the child's current weight status, the presence of obesity-related comorbidity in children and the presence of obesity in at least one or both parents.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6-12 years old
* Overweight status or obesity (i.e. BMI-for-age \> 85th percentile)

Exclusion Criteria:

* Age range not within the inclusion criteria
An Open Study to Assess the Robustness of the CRC749 Inhaler

To confirm the robustness of the CRC749 inhaler.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females at least 12 years of age.
2. A clinical diagnosis for at least 12 weeks prior to screening of asthma or COPD and stable treatment.
3. Spirometry following salbutamol showing FEV1 ≥40% of predicted normal and FEV1/FVC ratio \<0.7 for COPD subjects.
4. Spirometry without salbutamol showing FEV1 ≥50% of predicted normal for asthma subjects.
5. Ability to use the CRC749 inhaler.

Exclusion Criteria:

1. Other chronic or active respiratory disorder or symptoms of, or treatment for a COPD or asthma exacerbation during the 28 days preceding screening.
2. History of long QT syndrome or screening ECG with QTcF greater than 480 milliseconds.
3. Current evidence of, or history within the 6 months prior to screening of unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, or myocardial infarction.
4. Subjects in whom Advair(R) Diskus(R) / Seretide(R) Accuhaler(R) are contra-indicated.
Stoma Hernia Intraperitoneal Full-Thickness Skin

This is a prospective randomized study to compare surgical methods for the repair of parastomal hernia.

Parastomal hernia is a common complication to a stoma which can cause considerable suffering for the patient. The conventional methods of repair available today have disappointing results with high recurrence rates and serious complications. Some of the complications can be related to the introduction of foreign material into the abdominal wall. The investigators hypothesis is that the use of autologous full-thickness skin graft as reinforcement material can offer an alternative with fewer complications and recurrences.

Patients with symptomatic parastomal hernia will be included in a prospective randomized multicenter study comparing reinforcement with conventional synthetic mesh (with the best available technique today), to full thickness skin grafts placed in an intraperitoneal position. The intervention will be blinded to the participants, nursing staff and the follow-up staff. The participants will be followed up at 3, 12 and 36 months monitoring complications, recurrences, quality of life, strength of the abdomino-lumbar girdle and calculations will be done on the health economics.

Eligibility Criteria:
Inclusion Criteria:

* Colo-, ileo- or urostomy
* Parastomal hernia diagnosed with intrastomal ultrasound and/or CT
* Symptoms from the parastomal hernia requiring surgical intervention
* Informed consent
* \>18 years of age
* Sufficient knowledge in the Swedish language so that questionnaires can be answered

Exclusion Criteria:

* Cognitive impairment unabling compliance to post-operative prescriptions and/or answering questionnaires
* Insufficient amount of good quality skin suitable for transplantation
* Expected high donor-site morbidity
* Fistula/e adjacent to stoma
* Mb Crohn
Prospective Clinical Observational Cohort Study to Evaluate the Use of a Tissue Separating Mesh (Proceed®) in Laparoscopic Ventral Hernia Repair

1. General: antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery
2. Laparoscopic surgery

   * at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm)
   * with or without anchoring transparietal sutures or double crown technique


Eligibility Criteria:
Inclusion Criteria:

* written informed consent from the patient or his/her legal representative
* ventral hernia requiring elective surgical repair

Exclusion Criteria:

* no written informed consent
* 'hostile' abdomen; open abdomen treatment
* contraindication to pneumoperitoneum
* emergency surgery (incarcerated hernia)
* parastomal hernia
Effectiveness of Relaxation Methods in Total Knee Arthroplasty Patients

In this study, the effectiveness of a comprehensive training program consisting of pain management, relaxation, breathing, massage and falling components will be investigated in patients with total knee arthroplasty. In this randomized controlled study, the trainings will be offered face-to-face after the initial evaluation and within the scope of telemedicine with prepared videos. The first evaluation will be performed on the first postoperative day and the last evaluation will be performed 3 months postoperatively. The aim of this study is to evaluate the effectiveness of a comprehensive education program consisting of pain management, relaxation, respiration, massage and fall components in patients with total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged 50 and over
* Participants indicated for unilateral or bilateral total knee arthoplasty
* Individuals to be followed after surgery

Exclusion Criteria:

* Other surgeries
* Individuals with neurological and orthopedic diagnoses
* Individuals with cognitive, hearing, speech and psychiatric problems that prevent them from communicating
* Illiterate individuals
* Presence of malignancy
* Not signing the consent form
A PMS of Jakavi® in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea

This study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of Jakavi® (ruxolitinib) in the real-world clinical setting in Korean Graft-versus-Host disease (GvHD) patients

The dosage and duration of treatment may be considered and decided by the investigator in accordance with prescribing information of Jakavi®. All participants who receive at least one dose of the drug and are in the follow-up assessment or early discontinuation (withdrawal) will be the safety population. This study will enroll patients who are newly starting Jakavi® and patients who have been taking Jakavi® prior to study participation. Considering the current clinical practice, a 24 weeks follow-up period of ruxolitinib treatment is needed to assess the safety and the durable effectiveness of the treatment. Mandatory additional safety monitoring will be conducted following the last dose of the treatment for further AE assessments.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who diagnosed with GvHD and currently receiving or going to receive Jakavi® treatment according to locally approved label
2. Patients who are willing to provide written informed consent prior to study enrollment

Exclusion Criteria:

1. Patients under 12 years old
2. Patients with contraindication according to locally approved label of Jakavi®
3. Patients who receive or are going to receive any investigational medicine during the observation period.
Feasibility Study of Resistance Training Intervention in Untrained Adolescents

Adolescents may have limited time to engage in physical activity during the school day prompting investigations of before and after-school times along with time efficient programming. High-resistance circuit training has been used as a time effective protocol, however adolescents have yet to be studied. The primary aim was to assess feasibility (recruitment, sample size, consent rate, retention rate, fidelity, attendance, adverse events, and participant experience) of a high-resistance circuit training or strength training intervention, conducted before or after-school. The second aim was to explore changes in body composition, strength, and aerobic fitness.

Researchers compared feasibility outcomes as well as participant experience between time frames and treatment group.


Eligibility Criteria:
Inclusion Criteria:

* Untrained
* Male and female
* Student at site
* Available to workout before or after-school

Exclusion Criteria:

* Recent injuries or medical conditions that may influence high-intensity performance
* Currently enrolled in another training program including resistance, cardiovascular, or sports-based program
* Uninsured participants
* Drastically altering diet
* Use of performance-enhancing substances (i.e., creatine, pre-workout, post-workout supplements).
An Observational Clinical Study on the Construction of an Artificial Neural Network Model for ICU Pneumonia

To achieve rapid, intelligent and accurate microbiological diagnosis and treatment for ICU pneumonia, an artificial neural network model for microbiological diagnosis is established, which depends on many clinical cases and machine deep learning from clinical experts' judgements according to species-specific rapid detection of pathogenic bacteria and other clinical parameter variables of patients.

This study is a prospective single-centre observational study, 600 ICU pneumonia patients are expected to be selected as the observation object, and the lower respiratory secretions of patients on d1, d3 and d7 after enrollment are collected for species-specific rapid detection and microbial culture, while the general information of the patients and the clinical information of the corresponding time points on d1, d3 and d7 are collected. Two experienced senior physicians were organized to determine whether the microbial results were colonized or infected, and an artificial neural network model for rapid and intelligent diagnosis of pathogenic microorganisms in ICU pneumonia will be established and validated through multi-dimensional machine learning.

Eligibility Criteria:
Inclusion Criteria:

1. aged ≥18 years;
2. agreed to obtain lower respiratory specimens for rapid testing of pathogenic bacteria;
3. all were enrolled by an experienced physician who dynamically determined that the microorganisms were in a colonised or infected state;
4. signed an informed consent form.

Exclusion Criteria:

1. pregnant women;
2. lactating women;
3. patients who could not obtain lower respiratory specimens;
Healthy Living Programme for Older Adults

Malnutrition, risk of falls and medication incidents are commonly faced by the older adults. This study aimed to provide health education to community-dwelling older adults and to assess the effectiveness of a Healthy Living Program (HLP) to older adults in terms of fall prevention, drug management and healthy eating habits.

This was a single group pre-post trial. Participants aged 60 or above were recruited from the community elderly centres. A 6-week HLP, which included one 45 minutes weekly session, was offered to the participants.

122 participants were recruited. This study shows that the 6-week HLP has a potential to improve the physical well-being of the participants, and to increase their knowledge in diet, drug management and fall prevention.

Eligibility Criteria:
Inclusion Criteria:

* able to communicate and understand Cantonese
* \> 1 in frailty score
* members of the Pentecostal Church of Hong Kong

Exclusion Criteria:

* nil