cyrilzakka/clinical-trials huggingface dataset:
Dolutegravir Expanded Access Study

ING114916 is an open-label, multi-center, expanded access (EAP) study

ING114916 is an open-label, multi-center EAP to allow access to patients with HIV-1 infection who have documented raltegravir or elvitegravir resistance, have limited treatment options and require dolutegravir to construct a viable anti-retroviral regimen for therapy. Patients must not be eligible for another ongoing dolutegravir clinical trial in order to participate in this EAP.

The duration of patient accrual into the study will extend until dolutegravir receives local (by country) regulatory approval.

Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects greater than 18 years of age 2. Documented HIV-1 RNA \>/= 400 c/mL 3. Documented raltegravir or elvitegravir resistance 4. Inability to construct a viable background ART regimen with commercially available medications.

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Exclusion Criteria:

1. Creatnine clearance \< 30ml/min via Cockcroft-Gault method
2. Females who are pregnant and/or breastfeeding
3. Patients with known integrase allergic reaction
4. ALT \> 5 times the ULN within one month of treatment initiation
5. ALT \> 3 times ULN and total bilirubin \>1.5 times ULN
6. Evidence of severe hepatic impairment
7. Patients eligible for, and have access to, an actively enrolling DTG Phase III clinical study
8. Any condition or any active clinically significant disease during screening, anticipated requirement for any prohibited concomitant medications -
Establishing a Longitudinal Cohort Study of Lung Cancer Using Tissue and Peripheral Blood Metabolomics.

This study will utilize tissue and peripheral blood samples for metabolomics analysis and establish a longitudinal metabolomics cohort at multiple critical treatment time points to comprehensively investigate the role of metabolomics in the diagnosis, prognosis, and therapeutic monitoring of lung cancer. By profiling metabolic alterations, this study aims to identify potential biomarkers for distinguishing benign and malignant lung nodules, predicting therapeutic efficacy, and assessing long-term prognosis. Key time points include initial screening for lung nodules, postoperative evaluation to predict treatment outcomes, and therapeutic monitoring to assess efficacy after medication or other interventions. Through these analyses, the study seeks to uncover underlying metabolic mechanisms and provide valuable insights into personalized lung cancer management.


Eligibility Criteria:
Inclusion Criteria:

1. Signing of the informed consent form;
2. Male or female, aged 18-75 years;
3. Patients with lung nodules confirmed by CT examination;
4. Good preoperative pulmonary function cooperation and complete reporting;
5. Preoperative chest single/dual phase CT scans without significant artefacts and with complete imaging;
6. The interval between preoperative pulmonary function and single/dual phase CT scans does not exceed one month.

Exclusion Criteria:

1. Poor preoperative pulmonary function cooperation or missing reports;
2. Preoperative chest single/dual phase CT scans exhibit significant artefacts or image omission;
3. The interval between preoperative pulmonary function and single/dual phase CT scans exceeds one month;
4. Complication with severe respiratory disorders (such as lung transplantation, pneumothorax, giant bullae, etc.);
5. Coexisting with other severe functional impairments;
6. Patients with obstructive lesions such as airway or esophageal stenosis;

(8) Medication use before pulmonary function testing that does not meet the cessation guidelines; (9) Pulmonary function report quality graded D-F.
Expectation and Satisfaction of Implant Rehab After Jaw Surgery

Objective: The aim of this prospective study was to investigate the patient-reported outcome measures (PROMs) of implant-supported prostheses (ISP) among patients who had excised pathological jaw lesions.

Material and Methods: Patients who met the inclusion/exclusion criteria in a dental teaching hospital were recruited. Data pertaining to sociodemographic factors, conditions requiring surgery, surgical procedures and related complications, and types of ISP were collected. Patients' expectation and satisfaction to the ISP including oral health, self-perceived appearance, speech, chewing ability, oral comfort and ease of cleaning were assessed using the visual analogue scale (VAS, 0-100) and global transitional scale/judgement (Likert scale). Data were analysed using t-test and chi-square tests at the significance level α=0.05.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have received surgical removal of pathological jaw lesions in Queen Mary Hospital
* Subjects who plan to receive implant-supported prostheses in Prince Philip Dental Hospital

Exclusion Criteria:

* Subjects with debilitating illnesses or complicating medical conditions
* Subjects who under age of 18 or unable to give consent
* Subjects with uncontrolled caries and periodontal disease
Drug-drug Interaction Study Between Orally Administered Rifampicin and Vilaprisan

This study will be conducted in a single center, open-label study with a single group fixed sequence design to evaluate the effect of repeated oral administration of 600 mg RIF(Rifampicin) given once daily over 11 days on the single oral dose pharmacokinetics of VPR(Vilaprisan) and on MDZ(Midazolam) as a reference (probe) substance.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female postmenopausal subjects
* Age: 45 to 65 years (inclusive)
* Body mass index (BMI) : ≥20 and ≤32 kg/m²
* Race: White

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Relevant diseases within the last 4 weeks prior to the first drug administration
* Existing chronic diseases requiring medication
* Known or suspected malignant tumors (including history of malignant tumors, with a status after treatment), known or suspected benign tumors of the liver and pituitary (including after treatment)
* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Regular use of medicines
* Repeated use of drugs during 1 week before first study drug administration which might affect absorption (e.g. laxatives, loperamide, metoclopramide, antacids, H2-receptor antagonists)
Cannabis and Thought Disorder in Schizophrenia

Recent studies have suggested a strong relationship between cannabis use and the level of thought disorder in subjects with schizophrenia. Moreover, the level of thought disorder has been associated with an increased functional connectivity between the temporal lobe and the Putamen. However, the brain mechanisms underlying these two relationships are still poorly known. Better understanding these mechanisms is important to improve patients' care, in particular among treatment-resistant patients.

The objective of the CANDI study consists of assessing whether the level of cannabis use in patients with schizophrenia modulates the level of thought disorder via a modulation of the functional connectivity between the temporal lobe and the Putamen. Analyses will be controlled for the composition of cannabis, in particular the tetrahydrocannabinol / cannabidiol ratio.

25 subjects with schizophrenia and current cannabis use will be recruited in the experimental group. The control group will consist of 25 subjects with schizophrenia but with no cannabis use.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 65
* Meeting the DSM-5 criteria for schizophrenia
* "Cannabis user" group: - Smoking at least two days per week during the previous months
* Displaying positive urine screen for cannabis
* "Non-cannabis user" group: - No episode of cannabis smoking during the previous month
* Negative urine screen for cannabis + no lifetime criteria for cannabis use disorder (assessment by an addiction specialist).

Exclusion Criteria:

* Current criteria for axis-1 psychiatric disorder other than schizophrenia
* Current criteria for any other substance use disorder except for nicotine use disorder
* Any contraindication for MRI
* Tutorship or curatorship
* Pregnant or lactating woman
Patient Perception and Clinical Efficacy of a Collagen Matrix for the Treatment of Peri-implantitis

This is a multi-centre, randomized clinical trial which evaluates the efficiency of the collagen xenograft (Muco-Graft®) in comparison to the autologous connective tissue graft for the augmentation of keratinized mucosa and gaining hygienic access to the implants diagnosed with peri-implantitis.

Nowadays, there is not enough evidence that evaluates the patient's perception of utilizing the soft tissue substitutes in comparison to the autologous connective tissue graft for the augmentation of the keratinized mucosa and gain of hygienic access to the implants with infectious pathology and with minimum or absent keratinized mucosa.

Therefore, the aim of the study is to evaluate the change of clinical parameters of peri-implant health and the patient perception of the procedure for augmentation of the keratinized tissues around dental implants with peri-implantitis.

The hypothesis is that collagen matrix of porcine origin is associated with lower patient morbidity, in comparison with autologous connective-tissue graft, when used for the augmentation of the keratinized tissues around endosseous dental implants with infectious pathology and with minimum or absent KT mucosa.

A sample 48 patients will be recruited basing upon the diagnosis of peri-implantitis and absent or insufficient peri- implant mucosa. 1 month after the non-surgical treatment, surgical procedure will be performed.

Peri-implant clinical and radiographic parameters, as well as patient perception of the therapy provided, will be evaluated before and at various stages (up to 52 weeks) after the surgical intervention. Also, change of vestibulum depth will be analyzed, as well as the time spent for the procedure measured.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent after the detailed information on the study.
* Adults aged at least 18 years old.
* Candidates for receiving augmentation of the peri-implant keratinized mucosa.
* Presence of the implant diagnosed with peri-implantitis (radiographic bone loss \> 2 mm, with a probing depth \> 5 mm, bleeding and/or suppuration (Lang et al., 2011)).
* Absent or insufficient keratinized peri-implant mucosa (\<2 mm).

Exclusion Criteria:

* General contraindications for the dental/surgical treatment;
* Inflammatory or autoimmune disease of the oral cavity;
* Implant with radiographic intraosseous defects more than 3 mm;
* Smokers \> 10 cig/day;
* Allergy to collagen or analgesics/anti-inflammatory non-steroid drugs;
* History of cancer in various parts of the body which required radiotherapy or chemotherapy during the last 5 years;
* Radiotherapy of the head or neck in the last 5 years;
* Actual medication with immunosuppressors, bisphosphonates or high doses of corticosteroids;
* Pregnant or lactating women;
* Women in fertile age, who do not use effective methods of contraception;
* Participants of other studies of biomedical investigation during the last 24 weeks before initiation of the study.
Use of a Share Decision Making Tool in the Care of Acute Cystitis Without Risk of Complication in Primary Care

the aim of this trial is to demonstrate that when caring women with symptoms of acute cystitis without any risk of complication, general practitioner may use share decision making tool to help patients better understand the stakes of taking antibiotics.

Each year, more than 2.000.000 patients visit their general practitioners for a acute cystitis. The scientific literature shows that acute cystitis without risk of complication cause complications, such as pyelonephritis, in a very rare cases. However, French guidelines systematically request an antibiotic therapy as soon as the diagnostic is confirmed with the only goal to lowering symptomatology.

Recent studies show that some informed women would like not to take antibiotics and pain-killers could be as effective as antibiotics. Canadian studies assessing share decision making tools in patients with acute respiratory infection have shown that matching antibiotic treatment with the patient values lower such prescription without any impact on clinical outcomes .

Investigators aim to assess a similar strategy in patients with acute cystitis. This study will compare a group following French guidelines versus one using a share decision making tool to determine if, after being informed of the benefice and risk of this treatment, patient still want an antibiotic. Targeting instead of systematic prescription will reduce antibiotic consumption.

After diagnostic of acute cystitis to a woman between 18 and 65 years, investigators check if they filing all study criteria and ask for authorization to add them to the study. Then they'll act following their group instruction, and get information (antibiotic prescription or not, score to the Activity Impairment Assessment (AIA) scale, Score to satisfaction scale). Then patients will be followed by phone contact on day 5, day 14 and day 90 after inclusion to get information on antibiotic use, AIA and satisfaction scores and clinical outcomes, such urinary infection. Data on antibiotics delivery by pharmacy will be obtained through National assurance database.

Eligibility Criteria:
Inclusion Criteria:

* woman
* between 18 and 65 years
* symptom of acute cystitis without risk of complication
* affiliated to the French public welfare system
* with signed consent

Exclusion Criteria:

* anomaly of the urinary canal
* pregnancy
* more than 3 cystitis during the last year
* cancer, immunosuppression
* hemopathy, fever
* back-pain
* severe renal failure
* refuse to give consent and previously participate to the study
* under guardianship
Relationships Between Macular Pigment Optical Density and Lacquer Cracks in High Myopic Patients.

Lutein ans zeaxanthin, carotenoids provided by dietary intake are mainly located in the macular area.

Its absorption peak at 460 nm may reduce photic damages. The macular pigment density can be evaluated by its optical density.

Reduced macular pigment level is a significant risk factor for age-macular degeneration. The nutritional intake can minimise the risk of age-macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years-old
* High axial myopia \< -6 dioptries
* Presence or not of lacquer cracks in Bruch's membrane in one or both eyes
* Patients with social security coverage

Exclusion Criteria:

* Age \<18 years-old
* Amblyopia in the studied eye
* Prior ocular surgery
* Corneal disease or severe dry eye syndrome
* Other retinal disease: diabetic retinopathy, age-related macular degeneration, macular hole, epiretinal membrane central
* Extensive chorioretinal atrophy
* Allergy to tropicamide
* Pregnancy
Integrating ESAGE with EHR Data Using Machine Learning for the Early Detection and Monitoring of Cognitive Impairment in Individuals

The goal of this observational trial is to leverage the electronic Self-Administered Gerocognitive Examination (eSAGE), a variety of metadata (a set of data that describes and gives information about other data) collected during eSAGE testing, electronic health records (EHR) information, and advanced machine learning (ML) techniques to develop a new tool that can aid in early-stage prediction of individuals with cognitive impairments.

This is a retrospective and prospective record review trial for patients who are followed at the Center for Cognitive and Memory Disorders.

eSAGE assessment data (including cognitive data, behavioral data, timing data and other metadata) as well as varying amount of electronic health records (EHR) data will be collected on all eligible subjects. Machine learning techniques with feature selection will identify important EHR variables to determine what may be useful for the prediction of cognitive impairment.

Based on the EHR analysis additional questions will be added to the eSAGE to make an enhanced eSAGE version (eSAGE+). The goal of the eSAGE+ is to facilitate the identification of cognition impairment, and ultimately have a translational impact on Alzheimer's disease (AD) identification and management.

Eligibility Criteria:
Inclusion Criteria:

* 1. Males and females 50 years of age and over who complete the eSAGE as part of their office visit at the Center for Cognitive and Memory Disorders.

Exclusion Criteria:

* None
mGluR5 Imaging in ALS Using PET

In ALS models, it was shown that receptors, that bind an important messenger substance (glutamate) in the brain, are increased. In this research project, the investigators want to use a specific radioactive substance to find out whether these receptors are more detectable in people with ALS than in healthy people and increase over the course of the disease.

With this study, the investigators want to examine whether receptors (docking points on the surface of a nerve cell) that bind an important messenger substance in the brain (glutamate) are increased in patients with amyotrophic lateral sclerosis (ALS) as the disease progresses. Based on observations from ALS models, the investigators suspect that this increase in receptors contributes to the damage to the nerve cells in ALS.

To image these receptors, the investigators use a specific radioactive substance and imaging combining positron emission tomography (PET), magnetic resonance spectroscopy (MRS) and magnetic resonance imaging (MRI) of the brain and spinal cord.

The investigators will examine healthy people and ALS patients. The reason is that little is known about the receptor, even in healthy people. The investigators also do not know if and when the receptor is increasingly detectable in the course of the ALS disease. Only by comparing diseased and healthy people it can be determined if and when the receptor is built up in ALS patients. The investigators also hope to gain more information, e.g. about the distribution of receptors in the brain of healthy people compared to patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinically probable, probable laboratory supported, or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria (EEC) (45)
* Disease duration ≤18 months
* Pre-study ALSFRS-R progression between disease onset and screening of - 0.4 points/month or worse (calculated by ALSFRS -R total score decline form 48 divided by the months since onset of ALS symptoms)
* Upright slow vital capacity (sVC) ≥65 % of normal (best of three measurements)

Exclusion Criteria :

* Previous participation in another clinical study involving trial medication within the preceding 12 weeks
* History or presence of significant psychiatric disease, such as depression, evaluated with the ALS depression questionnaire (ADI-12) ≥ 23 (43) since depression has an impact on mGluR5 expression (44)
* Use of tobacco, including cigarettes, smokeless tobacco, cigars, and pipes; Ex- smoker having quit smoking ≥ 2 years
Brief Writing Programs for Sexual Minority Young Adults in Alabama

Sexual minority (SM; e.g., gay, lesbian, bisexual, pansexual, queer) young adults are at elevated risk for eating disorders (EDs). Researchers have used minority stress theory to understand how increased risk is due, in part, to stigma and discrimination from being part of a marginalized group. Despite this glaring inequity, limited programs exist to prevent EDs in SM populations. Critically, many SM young people live in rural regions with high anti-LGBTQ+ stigma and limited access to SM-specific resources. The proposed project will address this gap by adapting and evaluating two brief online interventions to reduce ED risk. N = 120 SM young adults in rural regions of Alabama with high LGBTQ+ stigma and low SM-specific resources will be randomized into one three brief online writing interventions: 1) expressive writing (n = 40), 2) self-affirmation (n = 40), or 3) control (n = 40). Participants will complete assessments pre-intervention, post-intervention, and 1-month post-intervention. Aim 1 will assess intervention feasibility and acceptability. Aim 2 will compare the brief online writing interventions to control in improving body image and ED symptoms. Finally, an exploratory aim will examine posited intervention mechanisms and whether the level of SM stigma and discrimination participants experience pre-intervention impacts intervention efficacy. This research will help support and benefit underserved SM young adults by filling a critical need for brief, scalable interventions that can be delivered online to help reduce ED risk. Data from this project will serve as pilot data for a subsequent R-series grant application from NIH.


Eligibility Criteria:
Inclusion Criteria:

* ages 18-30
* identify as SM (gay, lesbian, bisexual, pansexual, or queer)
* endorse body dissatisfaction
* currently living in one of the following AL counties: Lee, Dallas, Lowndes, Autauga, Coosa, Elmore, Tallapoosa, Macon, or Russell
* have internet access (either via computer/tablet, mobile phone, or community center\[e.g., library\])

Exclusion Criteria:

* meet criteria for an ED, based on self-report screener
* non-English speaking
* Lack of internet access
* Not living in one of the following AL counties: Lee, Dallas, Lowndes, Autauga, Coosa, Elmore, Tallapoosa, Macon, or Russell
* Younger than 18, older than 30
Airway IgA: Respiratory Tract IgA Levels in Anesthetized Patients Undergoing Elective Surgical Procedures

The purpose of the study is to determine the variability of airway IgA levels in anesthetized, well-nourished and malnourished patients undergoing elective general surgical procedures and the effect of gender and race on this baseline variable. The hypothesis is that airway IgA levels are lower in malnourished than in well-nourished patients.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing surgery via general anesthesia

Exclusion Criteria:

* Patients with a history of asthma or documented airway irritability
* Patients who have undergone previous pulmonary resection
* Patients receiving cardiac medications for arrhythmias.