cyrilzakka/clinical-trials huggingface dataset:
A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women

To determine the efficacy and safety of intravaginal fluorouracil administered as prophylaxis in HIV-infected women who have received standard ablative therapy (surgery) for high-grade cervical dysplasia (pre-cancer of the cervix; cervical intraepithelial neoplasia). To correlate time to recurrence of cervical dysplasia with T-cell function.

Women with HIV infection are at greater risk for cervical dysplasia. Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer, there is an urgent need to develop appropriate therapies.

Women with HIV infection are at greater risk for cervical dysplasia. Because of the likelihood that untreated or recurrent cervical dysplasia may progress to invasive cancer, there is an urgent need to develop appropriate therapies.

Patients are randomized to receive either intravaginal fluorouracil or no treatment (observation only). Fluorouracil cream is self-administered via applicator at biweekly intervals for 6 months. Patients are evaluated for recurrent cervical dysplasia by cytology and colposcopy with or without biopsy.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiretrovirals (AZT, ddI, ddC) and immunomodulators (interferon and interleukin).
* Prophylaxis or treatment for opportunistic infections.
* Vaginal antifungal agents or other indicated vaginal medications (although not permitted on day of fluorouracil application).
* Contraceptives.
* Acyclovir (prophylaxis or treatment) in patients with a history of primary or recurrent genital herpes.

Patients must have:

* HIV infection.
* Prior cervical dysplasia (grade II or III cervical intraepithelial neoplasia) successfully treated with an ablative procedure within the past 12 weeks.
* Patients less than 18 years of age must have consent of parent or guardian.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Untreated or persistent vaginal or vulvar dysplasia.
* Colposcopy or biopsy inconclusive or positive for dysplasia.
* Active genital ulcerative disease such as syphilitic chancre or herpes ulcer.
* Adenocarcinoma in situ.

Concurrent Medication:

Excluded:

* Cytotoxic chemotherapy for malignancy.
* High-dose steroids (\> 10 mg/day prednisone or its steroid equivalent).

Patients with the following prior conditions are excluded:

* Malignancy requiring cytotoxic chemotherapy within the 3 months prior to study entry.
* Prior hysterectomy.
* History of allergic reaction or severe hypersensitivity to fluorouracil.

Prior Medication:

Excluded:

* Fluorouracil (systemic or topical) within 3 months prior to study entry.
Spontaneous Evisceration of Infantile Umbilical Hernia

Infantile umbilical hernia is common in children. It has a regressive course in most cases. Conservative management is the standard in most cases before the age of 3 years unless there are complications such as incarceration, rupture with evisceration which are extremely rare and warrants emergency surgery.

We present a rare case of a 6-month-old child with sudden spontaneous evisceration of infantile umbilical hernia.

Infantile umbilical hernia is common in children. It has a regressive course in most cases. Conservative management is the standard in most cases before the age of 3 years unless there are complications such as incarceration, rupture with evisceration which are extremely rare and warrants emergency surgery.

We present a rare case of a 6-month-old child with sudden spontaneous evisceration of infantile umbilical hernia.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric group

Exclusion Criteria:

* Adult group
Ascitic Fluid Microbiome in Liver Cirrhosis

Ascitic fluid microbiome is going to be investigated in this study by using internal transcripted spacer (ITS) and 16S ribosomal RNA (rRNA) polymerase chain reaction (PCR) and sequencing as conventional culture methods are lacking sensitivity regarding diagnosis of spontaneous bacterial peritonitis (SBP).

All patients with routinely performed ascitic fluid puncture and underlying liver cirrhosis are included in this study. Next generation sequencing (NGS) in ascitic fluid, skin swaps from puncture side and stool samples as well as conventional culture methods are performed to investigate the difference in the microbiome between patients with and without SBP.


Eligibility Criteria:
Inclusion Criteria:

* Underlying decompensated liver cirrhosis
* routinely performed ascitic fluid puncture
* informed consent

Exclusion Criteria:

-
Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers

The purpose of this study is to explore the possible cognitive effects of oxybutynin tablets and oxybutynin gel.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 60 and over
* English as a primary language
* Given written informed consent by signing and dating an informed consent form prior to study entry

Exclusion Criteria:

* Current diseases in which the use of oxybutynin is contraindicated
* History of narrow-angle glaucoma or urinary or gastric retention
* Current use of drugs known to effect memory and cognition

Other protocol-defined inclusion/exclusion criteria may apply
Effect of Home Exercise on Reducing Falls

This proposed randomized controlled trial aims to study the long-term compliance of the LiFE program and its combined effects with a home safety visit on fall prevention in community-dwelling older fallers.

This will be a single-blinded randomized controlled trial. The subjects will be randomly assigned to the LiFE exercise plus home safety assessment group, or the control group by a computer program operated by an independent researcher. This study conforms to the ethical principles of the World Medical Association Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

* aged 60 or older
* able to ambulate with a Functional Ambulation Category (FAC) score ≥ 3
* able to walk for ≥ 10 meters
* history of falls in the past 12 months
* living in the community
* without MCI or dementia according to the 5-minute Montreal Cognitive assessment
* have a moderate fall risk or above as assessed by the Physiological Profile Assessment
* able to understand Chinese.

Exclusion Criteria:

* blindness
* diagnosis of mental disorders (e.g., severe depression, schizophrenia)
* any contraindications to exercise (e.g. unstable angina).
Brain Morphometry in OA Patients Treated With Duloxetine

This is a two week,single-blind study evaluating pain response and changes in brain imaging upon treatment with placebo in people with knee OA.

In this study, all the participants will be receiving placebo. However this study will be single blinded in that participants will be told that they will be given a pill that may or may not help with their pain. The researcher, however, will know that all participants are receiving placebo

At the initial visit, participants will undergo screening to determine that they meet all inclusion and exclusion criteria. They will sign consent and then complete pain assessment instruments as well as one high resolution anatomical scan (T1) and one functional scan (a resting scar) in a 3 Tesla magnet. A single scanning session comprised of a 10 minute functional scan (a resting scan) will be done two weeks from the first scan and pain assessment instruments will be completed at this visit as well. After finishing this second scan (done two weeks after the initial scan), the participants will have completed the study.

Eligibility Criteria:
Inclusion Criteria:

* Age: 40-85 years
* ACR criteria for OA including Kellgren-Lawrence radiographic OA grades II-IV
* VAS pain score \>5/10 within 48 hrs of the phone screen and visit 1 (Screening)
* Knee OA for a minimum of 12 months
* Need for daily pain medication to manage symptoms of OA

Exclusion Criteria:

* Currently taking MAO inhibitors or any centrally acting drug for analgesia
* Narrow angle glaucoma
* Uncontrolled hypertension
* Co-existing inflammatory arthritis, fibromyalgia or other chronic pain state
* If a female, pregnant, trying to become pregnant, or lactating
* Major depressive disorder
* Substantial alcohol use or history of significant liver disease
* Diabetes, type 1 or type 2
* Condition in which the Investigator believes would interfere with the subject's ability to comply with study instructions, or might confound the interpretation of the study results or put the subject at undue risk
* Standard MRI safety exclusions
IMT in Ventilatory Muscle Metaboreflex in COPD

This research intends to evaluate if inspiratory muscle training (IMT) reduces inspiratory muscle metaboreflex through the decrease of calf vascular resistance and increase of calf blood flow in Chronic Obstructive Pulmonary Disease (COPD).

Patients will be selected from the Hospital de Clinicas de Porto Alegre's COPD ambulatory, by convenience. Afterwards, patients will be submitted to pulmonary function test (spirometry) and cardiopulmonary exercise tests (incremental and submaximal), maximal inspiratory pressure evaluation and induction of the inspiratory muscle metaboreflex through venous occlusion plethysmography. Disease specific health related quality of life questionnaire (Saint George Respiratory Questionnaire) and daily life dyspnea questionnaire (Baseline Dyspnea Index and Transitional Dyspnea Index) will be administered at the first and last visit of each subject. Patients will undergo inspiratory muscle training for 30 minutes per day, 7 times a week, for 8 weeks, with Inspiratory Muscle Trainer device (PowerBreath Inc.). There will be a weekly follow up at the institution's Clinical Research Center, where maximal inspiratory pressure (PImax) and inspiratory training techniques will be reevaluated. After this period, tests of pulmonary function, questionnaires exercise tolerance and induction of the inspiratory muscle metaboreflex will be reevaluated.

Eligibility Criteria:
Inclusion Criteria:

Selection of subjects will be made through the Hospital de Clinicas de Porto Alegre Pneumology Service's COPD ambulatory. The inclusion criteria consist of -patients with COPD with functional confirmation through spirometry as by previously defined criteria.

Those selected must be classified as GOLD II-IV, with moderate to severe expiratory flow obstruction.

Exclusion Criteria:

Patients will be considered ineligible for this study if they

* develop COPD exacerbation 8 weeks prior to recruitment
* if systemic corticosteroids are utilized (in the last three months)
* if there is history of acute myocardial infarction (in the last three months)
* if there is presence of neuromuscular disease
* history of cardiovascular disease or active smoking (in the last 6 months)
* clinical history of peripheral vascular disease and if age is equal or superior to 85 years
Multisite Study: Parental Training Using Video Modelling to Develop Social Skills in Children With Autism

This is a Brazilian multisite study to test the efficacy of an Applied Behavior Analysis (ABA) parent training using video modeling to teach parents of children with Autism techniques to apply to their children in order to improve eye contact and joint attention behaviors.

Our hypothesis is that children with Autism whose parents will be trained by videomodeling will have better eye contact and joint attention behaviors compared to children with Autism whose parents will not be trained.

Applied Behavior Analysis (ABA) is an intervention with proven efficacy in treating impairments on social functioning and daily-life activities of individuals with Autism Spectrum Disorder (ASD). In Brazil we have a limited number of qualified professionals and an increasing demand of families non-served in the public health system.

Our main objective is to standardize and test the efficacy of a model for parent training using video modeling for teaching eye contact and joint attention behaviors in children with ASD. These two behaviors are essential to develop adequate social interaction, the core impaired domain in ASD. It is a multisite study to be carried out at the Universidade Federal de São Paulo, Universidade de São Paulo and Universidade Presbiteriana Mackenzie. The sample will be composed of 70 children divided in control and intervention groups that will be randomly chosen. The intervention should be carried out in 21 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of Autism Spectrum Disorders
* Diagnosis of Autism Spectrum Disorders by means of ADI
* IQ equal or lower than 70 by means of SON
* Main caregiver's level of education \> primary education

Exclusion Criteria:

* IQ lower than 50 by means of SON
* Child who is receiving ABA therapy at least 10 hours per week
* Main caregiver diagnosed with Autism Spectrum Disorders
Hypertonic Lactate After Cardiac Arrest

The study is intended to test the hypothesis that sodium lactate infusion after resuscitation from a cardiac arrest will decrease the magnitude of brain damage, as measured by the serum biomarker concentration of NSE.

Background: In resuscitated patients after cardiac arrest, ischemic brain injury and cardiac depression due to the reperfusion injury are accountable for high mortality rate and poor outcome. Hypertonic sodium lactate (HSL) solutions have been proven to be safe in healthy volunteers and they have shown some benefits in patients with traumatic brain injury and those with myocardial ischemia and could decrease the burden of hypoxic lesions in these organs. The aim of this phase II study is to investigate whether HSL administration could reduce organ damage related biomarkers in serum and if the administrations of these solutions is safe and feasible in resuscitated patients after cardiac arrest.

Design: an investigator initiated, randomized, controlled, open label phase II clinical trial to test the safety and efficacy of the infusion of HSL in resuscitated patients after cardiac arrest admitted to the hospital. After resuscitation from CA, comatose patients will be screened for eligibility and randomized to receive either study treatment as HSL 1M infusion for 24h or standard of care.

Expected outcomes: This controlled trial will assess the safety and efficacy of the 1M HSL infusion in a cohort of comatose resuscitated patients after cardiac arrest. The results of this trial may provide useful information for a larger phase III clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Sustained (\> 20 minutes) return of spontaneous circulation (ROSC)
* Comatose (GCS \< 9)
* Time to ROSC \> 15'

Exclusion Criteria:

* Protected categories (Pregnant women)
* Anticipated withdrawal of support within 24 hours
* Traumatic cause of cardiac arrest
* Body weight at admission \> 120Kg
Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction

The investigators hypothesize that the dry eye caused by SS may include the evaporative type, resulting from the MGD. Furthermore, the investigators hypothesize that both pSS and sSS are associated with MGD.To test our hypothesis, we conducted a prospective clinical study in patients with SS (both pSS and sSS) and MGD, and the normal population All subjects were matched for both age and gender and assessed for tear function and ocular surface signs and symptoms.


Eligibility Criteria:
Inclusion Criteria:

* All the subjects are female and age between 50-60 years
* Patients with primary SS fulfilled the criteria established by the European Study Group
* Patients with SLE and RA met the criteria set by the American College of Rheumatology

Exclusion Criteria:

* The control history of autoimmune disease
Real World COVID-19 Antiviral Effectiveness Research

This study is a prospective observational cohort study to evaluate the benefit of oral antivirals (nirmatrelvir plus ritonavir or molnupiravir) in Ministry of Health institutions. In this study, we will observe the progress of COVID-19 study participants seen in the health clinic up to 90 days from their initial visit to the health clinic.

This protocol is a prospective, multi-center, observational cohort study to evaluate the benefit of oral antivirals (nirmatrelvir plus ritonavir or molnupiravir) in Ministry of Health institutions in preventing progression of COVID-19 to severe COVID-19.

In this study, we will observe the clinical outcomes (COVID-19 symptoms, hospitalization admission, mortality, long term COVID-19 symptoms) of COVID-19 study participants seen in the health clinic up to 90 days from their initial visit to the health clinic . The hypothesis is that oral antiviral is beneficial in preventing disease progression and reducing long term COVID-19 symptoms.

Eligibility Criteria:
Inclusion Criteria:

* All SARS-CoV-2 positive individuals who are eligible for oral antiviral treatment based on current Ministry of Health Malaysia guidelines.

Exclusion Criteria:

* Individual who received oral antiviral (either nirmatrelvir plus ritonavir or monupiravir) more than 5 days following their positive SARS-CoV-2 test date
Epidemiology of Gonococcal Arthritis (EpGAr)

The aim of this retrospective observational study was to describe the epidemiology of Neisseria gonorrhoeae septic arthritis over the last 10 years at Brest and Rennes university hospitals. The main question is whether there are any risk factors based on the epidemiological and clinical data on these cases. The second objective is to characterize the gonococcal strains isolated in order to determine whether there is a common clone, a virulence factor or specific resistance genes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a Neisseria gonorrhoeae-positive joint sample (from an enrichment vial or a native sample) between 2014 and 2024.

Exclusion Criteria:

* Patients with Neisseria gonorrhoeae-negative joint sample (from enrichment vial or native sample).
* Patients who have expressed opposition to inclusion in the study.
* Patients under legal protection (guardianship, curatorship, etc.).
Prialt (Ziconotide) In Severe Chronic Pain

The purpose of this study is to understand the effects of intrathecal ziconotide (an experimental pain medication) when the dose is slowly increased over a 3-week period in patients with severe chronic pain. During the weaning phase, the study will also gather information about switching from other intrathecal or IT medication (slowly pumped directly into the space around the spine) to other systemic pain medication (by mouth or through the skin using a patch). After being weaned off current IT medication, patients will be placed on IT ziconotide or placebo (non-active substance) as well as being allowed a stable dose of systemic pain medications.

Patients who complete this study may be eligible for long-term ziconotide therapy via extension protocol ELN92045-352.


Eligibility Criteria:
Inclusion Criteria:

* Patient is able to read, understand, and voluntarily sign the Institutional Review Board (IRB) approved, written informed consent document prior to the performance of any study-specific procedures;
* Patient must be male or female at least 18 years of age;
* Patient must have severe chronic pain for whom IT therapy is warranted;
* Patient must be willing and able to comply with the protocol, and able to maintain the Patient Daily Diary for Opioid Consumption;
* Patient must have an implanted programmable SynchroMed® Infusion System in place for the treatment of chronic pain;
* Female patients of childbearing age agree to use adequate, appropriate contraceptive methods.

Males and their partner(s) of childbearing age must use adequate, appropriate contraceptive methods.

Exclusion Criteria:

* Patient is pregnant or lactating;
* Patient has been on an investigational drug other than ziconotide or device within 30 days prior to the initiation of the study drug;
* Patients with a known hypersensitivity (allergy) to ziconotide or any of the excipients (other compounds) in the formulation;
* Patient has a condition that would contraindicate the use of IT analgesia, including the presence of infection at the microinfusion injection site (where the needle is inserted in your abdomen to fill the pump with medication), uncontrolled bleeding diathesis (tendency for bleeding) and spinal canal obstruction that impairs circulation of Cerebral Spinal Fluid.
Occlusion Balloon vs. 5FR Ureteral Catheter

Occlusion Balloon catheter provides the ability to occlude the exit of the kidney pelvis during percutaneous nephrolithotomy (PCNL) and potentially prevents the migration of stone fragments into the ureter. The necessity for it might be questioned during supine PCNL due to the upward oblique position of the kidney. The objective of the study is to compare the presence of ureteral stone fragments upon completion of supine PCNL with and without using an occlusion balloon catheter (OBC).


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and older.
* Diagnosed with kidney stones and scheduled for PCNL.
* Able and willing to provide informed consent.

Exclusion Criteria:

* Pregnant women
* Urinary tract anomalies such as urinary diversion, previous ureteral reconstruction surgeries, horseshoe kidney, solitary kidney, duplicated system, urinary stricture disease, ureteropelvic junction obstruction, pelvic kidney, stone in calyceal diverticulum.
* Prone procedure
TachoSil® Versus Standard Haemostatic Treatment of Haemorrhage in Cardiovascular Surgery (TC-023-IM)

To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery


Eligibility Criteria:
Inclusion Criteria:

All inclusion criteria must be answered "yes" for a subject to participate in the trial.

At Screening:

1. Has the subject given informed consent according to local requirements before any trial related activities? A trial related activity is any procedure that would not have been performed during the routine management of the subject. In this trial the screening is the first trial related activity.
2. For female subjects of childbearing potential: Is the pregnancy test at screening negative?
3. Does the female subject of childbearing potential use adequate contraception (contraceptive pill, contraceptive injection, contraceptive implant or intrauterine device)?
4. Is the subject ≥ 18 years of age?
5. Is the following planned: An elective surgery on the heart, the ascending aorta or arch, requiring cardiopulmonary bypass procedure?

   Intra operative (after primary haemostatic treatment):
6. Is bleeding from the heart muscle, the pericardium, a major vessel or a vascular bed that requires supportive haemostatic treatment present?
7. Has the area with the most problematic haemorrhage (target area) been identified? (please note that this must be done before randomisation).
8. Is it possible to compress the randomised treatment (TachoSil® or control fleece material) for 3 minutes?

Exclusion Criteria:

All exclusion criteria must be answered "no" for a subject to participate in the trial.

At Screening:

1. Has the subject participated in any other trial with an investigational drug or device within 30 days before inclusion in this trial?
2. Does the subject participate in a clinical trial concomitantly with the present trial?
3. Is the subject undergoing an emergency operation?
4. Has the subject a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
5. Is the subject suffering from known coagulopathy?
6. Is the subject currently participating or has the subject previously participated in the TC-023-IM trial?
7. Is the female subject pregnant or breast feeding?

   Intra operative (after primary haemostatic treatment):
8. Has liquid fibrin sealant/glue or TachoSil® been applied?
9. Has the following occurred: Disseminated intravascular coagulation (DIC), i.e. micro vascular bleeding?