cyrilzakka/clinical-trials huggingface dataset:
Development of a Silica Microparticle Taggant System to Measure ART Adherence

Developing technologies to help measure and provide tools to support medication-taking behaviors (medication adherence) is an important step to ending the human immunodeficiency virus (HIV) epidemic. TruTag Technologies has pioneered the use of a microparticle system that can be incorporated into the coating of medications may help users both identify the medication they are taking and record adherence events. By using a standard smartphone camera, shining light on TruTag-coated medications automatically identifies them to an onboard smartphone app which then indirectly records the adherence event. This study evaluates the real-world usability and feasibility of operating this system among people living with HIV (PLWH).

This is an open-label pilot trial of N=15 PLWH who are prescribed Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy) for antiretroviral therapy (ART). Participants will receive special TruTag-tagged Biktarvy and will be asked to scan their TruTag Biktarvy prior to ingesting it daily over 90 days. A companion smartphone app will record scans as an indirect measure of adherence. Included in the app will be a reminder system to nudge individuals to take their Biktarvy and a two-way text portal that allows participants to communicate securely with the study team. Participants will be screened and enrolled, and will then attend three monthly study visits, where the study team will assess adherence, dispense TruTag Biktarvy, and understand how the TruTag system is operated in the real world. At the final 90-day study visit, the study team will conduct a qualitative interview to explore acceptability and future design iterations of the TruTag system.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Living with HIV
3. Currently prescribed and taking Biktarvy as ART for at least 3 months
4. Undetectable viral load in prior 6 months
5. Owns iPhone model 11 or higher (non-SE only)

Exclusion Criteria:

1. Not English-speaking
2. Unwilling to interact with the TruTag app
Intrathecal Amniotic Fluid Stem Cells for Progressive Multiple Sclerosis

In this clinical trial, researchers are exploring a novel approach to delivering therapy directly into the spinal fluid, which surrounds and nourishes the brain and spinal cord. The study focuses on patients with progressive multiple sclerosis (MS), a form of the disease that leads to worsening disability without the typical relapses seen in other MS subtypes.

This investigational therapy involves the use of stem cells derived from amniotic fluid-the protective liquid surrounding a developing baby in the womb. To the best of the researchers' knowledge, these specific stem cells have never been tested in MS patients before. Amniotic fluid is ethically sourced from routine medical procedures during pregnancy, and similar stem cells can also be obtained from placentas that are typically discarded after childbirth.

Participants in the trial will receive multiple injections of these stem cells into their spinal fluid over the course of a year. Researchers will closely monitor for the safety of this therapy, as well as monitor the participants' walking ability and other neurological functions to assess potential improvements.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-60 years.
* Diagnosed with primary or secondary progressive MS according to the 2017 revised McDonald criteria.
* Expanded Disability Status Scale (EDSS) of 3.0 to 8.0 with at least one functional scale that is not vision or sensory or brainstem or cognitive or bowel/bladder that is scoring 3.0 or greater.
* Clinically stable as determined by their neurologist for the past 6 months.
* On no disease-modifying therapy (DMT) for at least 6 months, or on the same DMT for at least 6 months before study entry.
* Can give informed consent.
* Women of child-bearing age must practice adequate contraception techniques in the eye of the investigator and continue to do so during the study period.
* Must be a good candidate, known for compliance for example, in the opinion of the investigators.

Exclusion Criteria:

* Participation in another clinical trial within the last 30 days.
* Severe allergic reactions to any component of the study treatments.
* Significant comorbidities.
* Active infections or malignancies.
* History of a malignancy within the past two years except for skin cancer that has been excised and controlled with only surgical treatment, not requiring chemotherapy or radiotherapy.
* Any medical condition that the investigator deems as unsuitable with therapy.
* Prior organ, tissue, or stem cell transplant or cell therapy within 3 years of study entry
* A diagnosis of a progressive neurological disorder other than multiple sclerosis.
* Inability to have an MRI scan.
* Inability to have a lumbar puncture, for example severe bleeding diathesis.
* Pregnant or breastfeeding or intention to become pregnant during the study.
* The results of the following laboratory results deemed suitable by the investigators: CBC with diff, CMP, INR, aPTT, Hepatitis C serology, HIV serology, RPR.
Metformin in Patients With PCOS and Predictors of Poor Ovarian Response Ongoing In-vitro Fertilization

Metformin should be administered with caution and could be potentially dangerous in infertile patients with PCOS who show a poor ovarian response and are undergoing gonadotropin-based ovarian stimulation. However, data that address this point are totally lacking.

On the basis of these considerations, the aim of the current clinical trial was to test the hypothesis that metformin reduces the ovarian response in infertile patients with PCOS who have a potentially poor ovarian response and who undergo gonadotropin stimulation for IVF cycles.

Primary infertile patients with PCOS older than 35 years and/or with a basal follicle-stimulating hormone (FSH) level higher than 10 IU/L who were scheduled for IVF cycles were enrolled in the study protocol.

Eligibility Criteria:
Inclusion Criteria:

* PCOS
* Prognosis for poor response
* Infertility

Exclusion Criteria:

* Male factor infertility
* Tubal infertility
DP-R212 Pharmacokinetic Study Phase I

An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R212

An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R212, a fixed dose combination compared with coadministration of separate constituents in healthy adult volunteers

Eligibility Criteria:
Inclusion Criteria:

* BMI 17.5\~30.5
* signed the informed consent form prior to the study participation

Exclusion Criteria:

* Clinically significant disease
* Previously donate whole blood within 60 days or component blood within 30 days
* Clinically significant allergic disease
* Taken IP in other trial within 90 days
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result
Lung Function in Post-COVID-19 Nursing Home Residents

The coronavirus disease 2019 (COVID-19) took a toll in institutionalised older adults, who represent a vulnerable population in European countries.

The aim of this study is to identify the predictive factors that worsens lung function in post-COVID nursing home (NH) residents.

This is a multicenter case-control study in nursing homes of Osona (Catalonia), where individuals with worsened (cases) and normal (controls) lung function will be studied. The inclusion criteria are: female and male from 65 to 95 years old, preserved cognitive capacity and positive diagnosis of COVID-19 at least 3 months prior.

We will assess sociodemographic variables, lung function \[spirometry\], fatigue \[Chalder Fatigue Scale\], frailty \[Clinical Frailty Scale\], and activities of daily living (ADL) \[modified Barthel index\].


Eligibility Criteria:
Inclusion Criteria:

* male and female
* preserved cognitive function
* previous positive diagnosis of COVID-19 at a minimum of 3 months to the day of data collection
* individuals living permanently in a nursing home

Exclusion Criteria:

* individuals in coma or palliative care
* any contraindication to perform spirometry (severe hypertension, myocardial infarction in the past week, non compensated heart failure, etc).
Increasing Engagement in PTSD Treatment Through Patient Education and Patient Choice

The purpose of this program is to compare two different methods of matching a Veteran to a PTSD treatment.

Posttraumatic Stress Disorder (PTSD) is a serious disorder that affects many Veterans who have had a traumatic experience. The VA offers several different types of treatment for PTSD. We are researching different ways to match a Veteran to a type of treatment. Participants in this study will will be randomly assigned to either a 40-minute session in which they will learn about PTSD treatments and select a preferred treatment or to a 40-minute assessment interview. Those participants assigned to the assessment interview will have the opportunity to work with their Trauma Recovery Program provider to determine a plan for their PTSD treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of combat-related PTSD
* Newly enrolled in Trauma Recovery Program (TRP) at the Michael E. DeBakey VA medical center
* TRP provider approval

Exclusion Criteria:

* Previous participation in TRP treatment for PTSD
Assessment of Oral Health Knowledge, Attitude and Behavior of Adult Patients in Egypt

Oral health is a significant contributor to public health and is classified by the World Health Organization (WHO) as a major global health concern. Notably, one in two adults suffer from dental decay ,with oral diseases ranking among the most prevalent non-communicable disease (NCDs) . Thus, public health programs focus on modifying lifestyle factors for prevention rather than treatment. In developed countries , public health programs have successfully improved oral health through dietary and lifestyle modifications, as well as fluoride use .

Furthermore, oral health professionals have a crucial in role in influencing the behaviors of their patients and preventing oral diseases .Therefore, enhancing oral health knowledge is essential for positive health behaviors and hence better oral health outcomes .


Eligibility Criteria:
Inclusion criteria:

* Adult patients attending the diagnostic center in Newgiza University
* 18 years or older Exclusion criteria
* Patients who refuse to consent to participate in the survey
Retrospective Data Collection Study in Patients Receiving Two or More OZURDEX® Injections for Macular Oedema Secondary to Retinal Vein Occlusion

The purpose of this study is to use retrospective data to evaluate the efficacy, safety and re-injection interval of OZURDEX® in the treatment of macular oedema due to retinal vein occlusion (RVO) in patients who received OZURDEX® as part of the Belgium Medical Needs Program.


Eligibility Criteria:
Inclusion Criteria:

* Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
* Received at least two OZURDEX® injections in the study eye as part of the Belgium Medical Needs Program

Exclusion Criteria:

* None
Effect of Mitomycin C on Urethral Stricture Recurrence After Internal Urethrotomy

The aim of this study is to evaluate the efficacy of local injected mitomycin C at the time of internal urethrotomy in order to prevent the recurrence of urethral strictures.


Eligibility Criteria:
Inclusion Criteria:

* Male urethral stricture suitable for internal urethrotomy
* Stricture length less than 10 mm

Exclusion Criteria:

* Stricture length over 10 mm
* Benign prostate enlargement
Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease

o study population pharmacokinetics in Benznidazole-treated adult patients with Chronic Chagas Disease to get information to optimize drug doses.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with Chronic Chagas Disease diagnosed by 2 different and positive serological tests.
* Patients with Chronic Chagas Disease who are going to start treatment with Benznidazole.
* Any gender.
* All the participants must agree to participate in the study and must sign the informed consent.

Exclusion Criteria:

* Patients younger than 18.
* Patients with previous hypersensitivity to Benznidazole.
* Immunocompromised patients as AIDS, cancer, chemotherapy, longterm corticoids need, primary immunodeficiency, or any other.
* Hepatic dysfunction
* Renal dysfunction: serum creatinin higher than 3 mg/dl.
* Pregnancy or lactation.
* Low adhesion to treatment or check-up.
* Impossibility of follow-up.
* Severe adverse reaction to Benznidazole.
* Any other situation that could be risky for the patient.
Metabolism of the Insecticide Permethrin

Military personnel are exposed to the insecticide permethrin when using the DOD Insect Repellent System. A urinary metabolite of permethrin that is in high abundance and is relatively stable may be an ideal biomarker of exposure to this pesticide. Monitoring such a biomarker can prevent over-exposure. The objectives are to identify the most abundant human urinary metabolite following dermal exposure; to utilize this information to develop rapid laboratory-based and field portable methods to monitor the degree of an individual's exposure to permethrin.

Permethrin is applied to the forearm of the subject and remains for 8 hours. The exposed area is then washed with soap and water several times. 24 hour urine samples are collected at daily intervals for 192 hours. Blood and saliva samples are taken at pre-dose, 1, 3, 6, 9 12, 24, 48, 72, 96, 120, 144, 168 and 192 hours. Subjects must return to the clinic daily to drop off urine collections and have blood and saliva samples taken.

Eligibility Criteria:
Inclusion Criteria:

* self-report healthy adult men and premenopausal women

Exclusion Criteria:

* unusual alcohol, drug, cigarette use for last 3 years
* unusual exercise program for last 3 years
* under the care of a physician for a disease
* participated in any radioactive drug study
* pregnant
* lactating
* people who rely more on their arm due to illness or injury
* people with neurological or musculoskeletal diseases
* use of permethrin in the last 6 months
* people who apply pesticides as their primary occupation
Development and Evaluation of a CBT-based Transdiagnostic Transcultural Web App for Mental Health Problems

This study aims to (1) develop a CBT-based transcultural, transdiagnostic interactive web app and (2) assess the feasibility, acceptability, and preliminary efficacy of this intervention.

Three-quarters of the global burden of mental disorders, including depression and anxiety, lies in low and middle-income countries (LMICs) (WHO, 2017). However, the treatment gap for common mental disorders in LMICs is significant, with an estimated 90% of people in these settings unable to access appropriate mental health care (Vos et al., 2015).

Despite the strong evidence supporting effectiveness in several disorders, cognitive behaviour therapy (CBT) remains underutilized internationally due to the limited availability of comprehensive training programmes and qualified CBT-trained staff. (Myhr \& Payne, 2006). However, self-help and GSH can be delivered online and have been found to be effective and feasible for individuals with depression and anxiety (Andrews et al., 2018). Furthermore, leveraging the unprecedented increase in cell phone users and internet technologies, as well as the decline in prices of handheld mobile devices, may overcome barriers to care and address the substantial mental health treatment gap in these settings (Lambert \& Littlefield, 2009; Lewis et al., 2012; UN Foundation-Vodafone Foundation Partnership, 2020; WHO, 2011). We, therefore, propose the development and evaluation of a CBT-based transcultural, transdiagnostic interactive web app to address symptoms of depression, anxiety and stress.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 to 65 years
* At least 5 years of education
* Computer literate
* Owning a smartphone or a personal computer with a reliable internet connection
* Score of 8 or higher on Hospital Anxiety and Depression Scale-Depression or Anxiety scales as measured by their primary care clinician.

Exclusion Criteria:

* Substance use disorder according to DSM-5 criteria
* Significant cognitive impairment (for example, profound learning disability or dementia)
* Active psychosis as determined by their primary care clinician
Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues

Long-term (up to 3 years) clinical and hormonal outcomes in acromegalic patients with treated surgery with or without long acting somatostatin analogues.

Patients who are diagnosed with acromegaly with a GH-secreting pituitary adenoma receiving TSA at the Asan Medical Center (Seoul, Korea) from Aug 2013 to Aug 2015 will be recruited.

The eligible patient population will consist of 30 adult, male and female patient with Age 18 or older.

* Number of patients by treatment group: Surgical treatment only = 15, Surgery with medical treatment = 15
* Number of Centers: 1 (single center)

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older.
2. Patients diagnosed with acromegaly with GH-secreting pituitary adenoma on sellar MRI, meeting the biochemical criteria outlined above (refer to 1. Diagnosis of acromegaly) and with typical acromegalic features.
3. No prior use of somatostatin analogues.
4. Adequate hepatic and renal function
5. Provision of a signed written informed consent

Exclusion Criteria:

1. Severe co-morbid illness such as untreatable other malignancy and/or active infections.
2. Pregnant or lactating women
3. Hypersensitivity to Sandostatin or any component of the formulation.
Human Chorionic Gonadotropin (hCG) Test: A Novel Method to Evaluate the Ovarian Reserve

In an era of delayed fertility plans, there is an increasing need for a reliable method to predict ovarian reserve and responsiveness. The current tests include serum FSH, Inhibin B, Mullerian inhibiting factor (MIF) and ultrasonographic measures such as ovarian volume and number of antral follicles are non-specific and with questionable reliability. The biochemical tests represent the function of production of androgens, as a predictor of ovarian reserve, has not been tested yet.

Working hypothesis and aims: testing the prognostic capability of hCG stimulating test of theca cells for estimating the ovarian reserve, and by that to calculate better the chance for IVF cycle success

20 women \>40 years old and 20 women \<35 years old, attended to our IVF unit were included in the study. Another 20 other young women (\<35 years) with poor response in previous IVF cycles will be participate. All participants received a single hCG 10000 IU injection on cycle day 2-4. Hormone levels of LH, FSH, E2, P, Testosterone, Androstendione and 17-OHP were taken prior to the injection and on days 1, 3 and 7 afterwards. hCG induced hormone levels will be compared with IVF results

Eligibility Criteria:
Inclusion Criteria:

* All women on IVF cycle

Exclusion Criteria:

* Any allergy to injection of human chorionic gonadotropin before
An Efficacy and Safety Study of CNTO 1275 Compared to Etanercept in Patients With Plaque Psoriasis

The purpose of this study is to compare the efficacy and safety of CNTO 1275 to etanercept in patients with moderate to severe plaque psoriasis.

This is a multicenter, randomized (study medication assigned by chance), active-controlled, parallel, 3-arm study. Patients will be randomly (allocation to treatments available by chance) assigned in 3:5:5 ratio to receive one of three treatments groups. The three treatment groups are: Group 1 - CNTO 1275 45 mg dosing at weeks 0 and 4, Group 2 - CNTO 1275 90 mg dosing at weeks 0 and 4, Group 3 - Etanercept 50 mg two times per week through week 12. The total duration for each participant will be up to 64 weeks (approximately 16 months). The active-controlled portion of the study is from Week 0 to Week 12 during which the efficacy and safety of etanercept and 2 dose levels of CNTO 1275 will be evaluated. Treatment after Week 12 is dependent on Physician's Global Assessment (PGA) response at Week 12 and initial treatment assignment. Patients will receive 2 subcutaneous injections of CNTO 1275 (either 45 or 90 mg doses) or twice weekly injections of etanercept during the first twelve weeks of the study. Patients may receive two additional doses of CNTO 1275 (either 45 or 90 mg doses) up to week 44.

Eligibility Criteria:
Inclusion Criteria:

* Have had a diagnosis of plaque-type psoriasis at least 6 months prior to the study
* Have plaque-type psoriasis covering at least 10 percentage of total body surface area
* Have a Psoriasis Area and Severity Index (PASI) score of 12 or greater and a Physician's Global Assessment (PGA) score of 3 or greater at the time of the first administration of study drug
* Must be suitable for phototherapy or systemic treatment for psoriasis
* Have failed to respond to or have condition which prevents use of cyclosporine, methotrexate (MTX) or psoralen plus ultraviolet light A (PUVA)

Exclusion Criteria:

* Currently have nonplaque forms of psoriasis
* Have current drug-induced psoriasis
* Have used any therapeutic agent targeted at reducing interleukin-12 (IL-12) or IL-23 (Interleukins are the substance produced by body in immunological disease like psoriasis)
* Have received phototherapy or any systemic medications/treatments that could affect psoriasis or PASI evaluation (including, but not limited to, oral or injectable corticosteroids, retinoids, 1,25 dihydroxy vitamin D3 and analogues, psoralens, sulfasalazine, hydroxyurea, or fumaric acid derivatives) within 4 weeks of the first administration of study agent
* Have used a biologic within the previous 3 months