cyrilzakka/clinical-trials huggingface dataset:
Antiretroviral Therapy Adherence and Secondary Prevention of Human Immunodeficiency Virus

In this study, investigators propose to randomize 165 human immunodeficiency virus positive patients to one of three 16-week treatment conditions: (1) standard care; (2) standard care + cell phone-based adherence reminders; or (3) standard care + cell phone-based adherence reminders and contingency management. In this latter condition, patients will earn reinforcement for sending in time- and date-stamped self videos of antiretroviral therapy medication ingestion. Primary outcomes will include viral loads and self-report measures of adherence, and effects will be evaluated both during the treatment period and throughout a one-year follow-up. Investigators hypothesize that the cell phone reminder condition will improve adherence relative to standard care, and the cell phone reminder plus contingency management condition will have the best outcomes. Results from this study may have widespread implications for the use of cell phones as a novel technology to improve initial adherence to antiretroviral therapy, thereby reducing the spread of drug resistant human immunodeficiency virus strains to the community.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* initiating or on an antiretroviral therapy regimen and have a viral load \>200 copies/mL in the past 6 months
* one or more risk factors for poor adherence
* English speaking
* willing to use a cell phone to receive reminders and record medication ingestion for up to 16 weeks
* able to read at 5th grade level and pass a brief quiz related to understanding the informed consent form

Exclusion Criteria:

* living in an environment or has a visiting nurse that dispenses antiretroviral therapy medication
* participating in another antiretroviral therapy adherence study
* uncontrolled psychiatric disorders
* significant cognitive impairment
Optimizing Preoperative Disinfection of Eyes

Topical povidone-iodine (PI) is widely used as ocular antiseptic before and after surgery. The standard dose of 5% PI is however, associated with ocular irritation. We therefore want to test if a lower concentration of PI can be similarly efficacious in reducing bacterial growth while reducing ocular irritation.


Eligibility Criteria:
Inclusion Criteria:

* Patients remitted to intravitreal injections at St. Olavs hospital.
* Patients competent to give written consent

Exclusion Criteria:

* Infectious disease
* Known epitheliopathy
* Contact lens wear
* Use of prescription ophthalmic medications
* Diabetes
Efficacy of Deutetrabenazine to Control Symptoms of Dysphagia Associated with HD

To determine the efficacy of deutetrabenazine to control symptoms of dysphagia associated with HD.

The primary endpoint is the change in swallow function/dysphagia from baseline to maintenance therapy.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of HD
* Symptoms of dysphagia
* Must be able to swallow tablets

Exclusion Criteria:

* Other confounding diseases that affect swallowing
* Depression
* Hepatic impairment
* Renal impairment
* Dementia
Comparison Between High-sensitivity Cardiac Troponin T and Standard Tnl Assays in Early Cardiac Ischemia Detection

It is crucial to rapidly identify cardiac ischemia in the care of patients with suspected acute coronary syndrome (ACS). Cardiac troponins are a major factor in the diagnostic of myocardial infarction. New methods have been developed to improve the accuracy of the assay and determine low troponin concentrations. Elecsys® (highly sensible T troponin) TnT-HS assay is supposed to help early detection of myocardial infarction after onset of symptoms. It should therefore shorten the transit time to emergencies by a more rapid intervention or a faster return home. The aim of the study is to compare TnT-HS assay to the standard troponin assay in the detection of early cardiac ischemia in patients with ACS.

Patients with suspected ACS with 2/2 negative results of conventional troponin I assay and 1/3 positive result of highly sensitive troponin assay will have a non invasive cardiac Rb82 PET/CT performed within 24 hours of admission. This exam is recognized by Associations of cardiology for its high sensibility and specificity in coronary disease detection.

Eligibility Criteria:
Inclusion Criteria:

* chest pain of ≥ 5 minutes during the last 24 hours, or other symptoms suggestive of ACS (unstable angina or NSTEMI) with 2 negative standard troponin values(\<0.09 µg/L)
* age ≥ 18

Exclusion Criteria:

* patients with ST- segment elevation myocardial infarction (STEMI)
* detection of TnI standard values \> 0.09 (limit of positivity) in one of two blood samples (T0 and T6)
* detection of heart disease or extra-cardiac disease that could explain the elevated conventional troponin values
* presence of major organ dysfunction, infection or major underlying medical condition that could compromise the patient's ability to perform a stress test for myocardial ischemia
* cancer with prognosis \< 6 months
Bimatoprost in the Treatment of Eyelash Hypotrichosis

This study will evaluate the safety and efficacy of bimatoprost solution formulation A compared with bimatoprost solution 0.03% (LATISSE®) and vehicle in the treatment of eyelash hypotrichosis (inadequate eyelashes).


Eligibility Criteria:
Inclusion Criteria:

-Male and female adult patients with eyelash hypotrichosis (inadequate eyelash growth).

Exclusion Criteria:

* Damage to eyelid area (scarring) that may prevent growth of eyelashes
* Active eye diseases (glaucoma, uveitis, eye infections, chronic blepharitis or severe dry eye)
* Eye or eyelid surgery (including laser, refractive, intraocular filtering surgery, blepharoplasty) during the 3 months prior to screening
* Current eyelash implants of any kind
* Eyelash tint or dye application within 2 months of baseline
* Eyelash extensions application within 3 months of baseline
* Use of eyelash growth products within 6 months of baseline
* Treatments that may affect hair growth (minoxidil, cancer chemotherapeutic agents, etc) within 6 months prior to baseline.
Efficacy & Safety of 980nm Diode Laser vs. Cryotherapy for Plantar Warts

The goal of this clinical trial is to compare and test the efficacy of two treatments for plantar warts. The main questions it aims to answer are:

Which treatment has a higher cure rate for eliminating plantar warts? Which treatment causes less pain during the procedure?

Participants with plantar warts will:

Be randomly assigned to receive either cryotherapy or laser therapy Undergo 4 treatment sessions at weekly intervals Have their warts assessed for complete clearance after treatment Rate their pain levels during each session

Researchers will compare the cryotherapy and laser therapy groups to see if there are differences in:

Rates of complete wart clearance Pain levels reported during treatment Adverse effects

Background: Plantar warts are a common dermatological condition caused by human papillomavirus infection. They can be painful and negatively impact quality of life. Many treatments exist but there is lack of consensus on the optimal approach.

Objectives:

Primary objective: To compare the efficacy of 980nm diode laser versus liquid nitrogen cryotherapy for clearing plantar warts, as measured by the complete clearance rate at 4 weeks post-treatment.

Secondary objectives: To evaluate and compare pain levels during treatment procedures and adverse events between both groups.

Study design: Randomized, double-blind clinical trial.

Participants: 32 patients aged 18-65 years old with 1-3 plantar warts located on weight-bearing areas of the foot.

Interventions:

Laser group: 980nm diode laser applied to each wart for 5 seconds at 2W power and 1mm spot size. 4 sessions at weekly intervals.

Cryotherapy group: Liquid nitrogen sprayed on each wart using a standardised technique. Freeze-thaw cycle repeated up to 3 times per wart per session. 4 sessions at weekly intervals.

Main outcomes:

Complete clearance rate of plantar warts at 4 weeks treatment session. Assessed by physical examination.

Pain during procedure measured with Visual Analogue Scale (VAS). Adverse events monitored during follow-up.

Randomization and blinding: Subjects will be randomly allocated to each group with a 1:1 ratio. Investigators assessing outcomes will be blinded to group assignment.

Analysis: Intention-to-treat analysis will be performed. Chi-squared test will compare clearance rates. T-test will compare pain scores.

Eligibility Criteria:
Inclusion Criteria:

* Patients with recalcitrant, mosaic and simple HPV

Exclusion Criteria:

* Diabetic, ischaemic and immunosuppressed patients
* Patients with cold intolerance
* Patients with any of the following conditions (blood dyscrasias of unknown origin, cryoglobulinaemia, cryofibrinogenemia, collagen or autoimmune disease)
* Patients who do not sign the informed consent form.
Mixed Reality Gaming for Chronic Low Back Pain

Mixed Reality Gaming for Chronic Low Back Pain

The company, From the Future and University of Alabama at Birmingham (UAB) team aimed to develop a virtual reality (VR) game that integrated with the features of a specialized self-driven treadmill to provide accessible and progressive walking challenges for individuals with chronic low back pain (LBP). The game was designed to go beyond typical VR research efforts and provide a truly immersive and engaging experience that would motivate individuals with high pain-related fear to keep moving.

Eligibility Criteria:
Inclusion Criteria:

History of chronic low back pain

Exclusion Criteria:

No major neurological, cardiac, pulmonary, or other orthopedic injuries
Assessing Insulin Sensitivity and Diabetes Risk in Childhood Cancer Survivors Treated With Abdominal Irradiation

The purpose of this study is to better understand the risk factors and causes of diabetes in people who received radiation to the abdomen as children. The investigators hope this information will allow them to improve how they screen people at risk for diabetes and how they treat patients in the future.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of childhood cancer between 0-21 years of age
* Prior treatment with abdominal radiation at MSKCC
* Two or more years from completion of therapy
* Records of cancer diagnosis and treatment (including radiation records) available

Exclusion Criteria:

* Known diagnosis of diabetes
* Previous treatment with any radiation impacting the brain (cranial radiation, craniospinal radiation, total body irradiation)
* Neurocognitive deficits that impair ability to give informed consent or assent
* Patients predicted to have difficult intravenous access, who will likely require multiple venipuncture attempts
Thyroid Hormones in Critically Ill Children

Thyroid hormones are substances naturally made by the body and are important to many of your body's basic functions such as breathing and brain function. We are investigating whether or not these hormones are at lower levels in critically ill children which could lead to further health problems. We hope to get a better understanding of hormone levels and their effects on critically ill children to better help other children in the future.

We hypothesize that critically ill children that require vasoactive infusions and/or invasive mechanical ventilation have thyroid hormone alterations. We will measure TSH, tT3, fT3, rT3, tT4, fT4, adn tyrosine concentrations in critically ill children with hypotension and/or respiratory failure and correlate thyroid hormone alterations to severity of illness, intensity of therapeutic interventions, and associated morbidity and mortality by using clinical outcomes parameters.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Age of less than 12 months and less than or equal to 18
* Patient must weigh greater than 10 kgs.
* Patients must require vasoactive infusions and/or mechanical ventilation.
* Patients must be enrolled within 24 hours of meeting eligibility.

Exclusion Criteria:

* Patient with known or presumed pre-existing thyroid disease will be excluded
* Patients who receive thyroid supplementation will be excluded
* Patients with known or presumed hypothalamic and/or pituitary dysfunction that have thyroid hormone concentration abnormalities not related to an acute illness.
* Patients who are intubated for airway protection only.
* Patients intubated for neuromuscular disease
* Pregnant patients.
* Patients receiving amiodarone supplementation
* Patients who received blood product transfusions equaling more than 1/2 of their blood volume.
Clinical Prognosis and Progression of Myasthenia Gravis Patients

This study collects the clinical data of myasthenia gravis (MG) patients, assesses outcomes and adverse effects of different treatment regimens, and searches for risk factors of conversion to generalized MG.

This is a multicenter, observational cohort trial in the real-world clinical setting recruiting MG patients from Neurology Departments of 6 hospitals in different regions of China. Clinical manifestations, laboratory test results, chest imaging and history of thymectomy are recorded. Patients will be classified by clinical manifestation as well as antibody status, and treatment regimens are determined according to the physician's judgment and preferences of the patients. Patients are followed up prospectively on regular to assess the outcomes of treatments and monitor any side effects. Peripheral blood samples are collected annually. Patients' clinical records are uploaded to an online database. The investigators plan to recruit a final sample of 2000 patients for analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>14.
2. Clinical Diagnosis of MG with supporting evidence:

   1. unequivocal clinical response to pyridostigmine
   2. positive antibody testing
   3. decrement \>10% in repetitive nerve stimulations study (RNS) .
3. Willingness to sample collection, imaging study and other disease-related examinations and assessments.
4. Patients with informed consent.

Exclusion Criteria:

1. History of chronic degenerative, psychiatric, or neurologic disorder other than MG that can produce weakness or fatigue.
2. Age ≤14 years.
3. Severe anxiety, depression or schizophrenia.
4. Cognitive impairment or mini-mental state examination (MMSE) score ≤24.
5. Severe systemic illness with life-expectancy less than 4 years.
6. Unwillingness to consent for collection of biological samples.
7. Inability to provide informed consent.
Integrating PrEP Decision Making Into Contraceptive Counseling in Family Planning Clinics

This study addresses the need for HIV prevention to be integrated into contraceptive counseling visits at family planning clinics.

The purpose of this study is to expand and enhance a PrEP decision aid to include the full array of available formulation options and then integrate its delivery into sexual and reproductive health (SRH) settings during contraceptive counseling visits, where PrEP can be provided to all women who are interested. Rooted in the Health Equity Implementation Framework, this study evaluates health equity and implementation determinants simultaneously along: 1) innovation characteristics; 2) clinical encounter; 3) recipients; and 4) context.

In Aim 1, patients (n=15-20), clinicians (n=10), and staff (n=10) at SRH clinics across Greater New Haven, CT will be engaged for semi-structured interviews to expand and enhance an existing PrEP decision aid to include all available formulations and optimize its integration into SRH clinics. Qualitative interviews will inform infrastructure development to support PrEP delivery in SRH clinics.

In Aim 2 (a hybrid Type 2 effectiveness-implementation study), patients will be randomized (n=50) to receive either the PrEP decision aid or generic PrEP information prior to a clinician visit. In follow-up interviews immediately post-visit, and at Months 3 and 6, primary outcomes are clinical efficacy (PrEP initiation) and implementation (using Proctor definitions for feasibility, acceptability, penetration, and adoption) that are important for future planned scale-up.

Eligibility Criteria:
Patients (inclusion):

* Cis-women
* Aged 18 years or older
* Have a uterus
* Do not have HIV (by self-report)
* Not currently on PrEP
* Comfortable conversing in English or Spanish
* Able to participate in informed consent procedures

Patients (exclusion):

* People who cannot become pregnant (i.e., have had a hysterectomy or tubal ligation)
* People who wish to become pregnant (will not qualify for contraceptive counseling)
* Have a scheduled visit with a member of the investigative team (to minimize risk of potential ascertainment bias)
* Participants of Aim 1 cannot participate in Aim 2.

Sexual and Reproductive Health (SRH) clinicians will be included if they provide SRH patient care at any of the participating sites. SRH clinic staff will be included if they work at any of the participating sites and have patient-facing or non-patient-facing roles
99mTc-HFAPI SPECT/CT in Pulmonary Fibrosis

This prospective study will investigate the potential usefulness of 99mTc labeled FAPI SPECT/CT in the diagnosis, treatment response assessment, and follow-up of pulmonary fibrosis.

Idiopathic pulmonary fibrosis refers to a specific form of chronic fibrous interstitial pneumonia that occurs spontaneously, limited to the lung, and shows features of usual interstitial pneumonia on high resolution computed tomography and histological examination. Radionuclide labeled FAPI has been developed as a new tracer for tumor and inflammatory lesions imaging. Recent studies have shown that FAPI PET/CT imaging is a promising new imaging method for pulmonary fibrosis. HFAPI is obtained by conjugating 99mTc-chelator moiety (6-hydrazinonicotinamide, HYNIC) with FAP targeting moiety. The aim of this study is to investigate the location and extent of 99mTc labeled FAPI tracer (99mTc-HFAPI) in normal and fibrotic lung tissue of patients with pulmonary fibrosis, and to explore the clinical significance of 99mTc-HFAPI SPECT/CT in the diagnosis, treatment response evaluation and follow-up of pulmonary fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* suspected or confirmed pulmonary fibrosis patients;
* signed written consent.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* known allergy against FAPI
* any medical conditions that are considered by the investigator to be likely to seriously interfere with study compliance
Correlation Between Pressure Differences and Micro-vascularization Changes in Bedridden Paraplegic Patient

Paraplegic patients have defective wound healing for sore below the level of spinal lesion. Defect of vascularization of the healing zone certainly participate to this effect. Therefore, this study want to measure, in a clinical settings, the interface pressure (e.g. the pressure between the patient body and the surface he/she is lying on) to assess the correlation between mechanical stress in term of pressure applied over time and tissue oxygenation which represent micro-vascular function. The aim of this clinical trial is to correlate the variations of pressure intensities and changes in micro-vascularization. The measure are recorded when paraplegic patient came into the hospital for pressure ulcer related surgery. The patient is laying on his/her mattress on top of a flexible pressure mapping device. The micro-vascularization parameters are measured at the area displaying the peak pressure a few minutes after the beginning of the pressure interface recording and one hour later at the same area. The data generated during this monocentric study will help to achieve a better understanding of the relation between pressure and micro-vascularization. In the mid term, it will provide a better and more patient adapted pressure ulcer prevention.


Eligibility Criteria:
Inclusion Criteria:

* Educated consent signed,
* Older than 18,
* Paraplegia for at least 6 months,
* Surgery planned for pressure ulcer resection,

Exclusion Criteria:

* Dementia,
* Stade IV arteritis non-revascularisable,
* Patient with no health insurance,
* Pregnant women or breast-feeding, patient unable to give his or her educated consent, ward of the state (art. L.1121-6, L.1121-7, L.1211-8, L.1211-9),
* Patient taking part in another study which could impact the local micro-vascularization.
Predicting Bispectral Index Values by Estimated Effect-site Concentration of Propofol and Remifentanil Displayed on the Target-centered Infusion Pump

The BIS is influenced by multiple parameters, such as age,gender, body weight, height, muscle relaxants, hepatic function, co-administered drugs, surgical stimulation, but is thought to be influenced mainly by propofol and remifentanil infusion dose. As such, the investigators postulate that the BIS value could be predicted by the estimated effects-site concentration of propofol and remifentanil, and try to establish a multiple linear regression model for predicting BIS value.

Total intravenous anesthesia is commonly performed with propofol and remifentanil now-a-days. The combination of these two drugs can achieve the rapid loss of consciousness and analgesia,as the onset and recovery time of these two drugs are very fast within one to three minutes. However, the problem of intraoperative awareness necessitate the monitoring of anesthetic depth, which is commonly performed with Bispectral index (BIS). BIS is a display of number from zero to one hundred which quantify the degree of sedation and hypnosis by anesthetics by analyzing the electroencephalogram. However, it is limited in neurosurgery in which the surgical field is near the forehead where the BIS probe is attached. Furthermore, it is also limited in surgery with prone position. The BIS is influenced by multiple parameters, such as age,gender, body weight, height, muscle relaxants, hepatic function, co-administered drugs, surgical stimulation, but is thought to be influenced mainly by propofol and remifentanil infusion dose. As such, we postulate that the BIS value could be predicted by the estimated effects-site concentration of propofol and remifentanil, and try to establish a multiple linear regression model for predicting BIS value.

Eligibility Criteria:
Inclusion Criteria:

* Those undergoing gynecologic or urologic surgery with general anesthesia with total intravenous anesthesia
* Adult patients with more than 20 yrs.
* American Society of Anesthesiologists Class I or II.

Exclusion Criteria:

* Those with unstable hemodynamics
* Those who can not undergo Bispectral index monitoring
* Those with previous history of stroke