cyrilzakka/clinical-trials huggingface dataset:
Glutathione in Mild Cognitive Impairment

Elderly humans have an increased risk of dementia which begins as mild defects in memory called mild cognitive impairment. Glutathione (GSH), a key endogenous antioxidant has been linked to cognition. This exploratory study will investigate mechanisms linked to GSH for cognitive impairment (and improvement) by studying humans with mild cognitive impairment who will be evaluated 12-weeks after receiving either N-acetylcysteine and glycine (GSH precursors), or receiving alanine, and a further 12-weeks after stopping these supplements.

Subjects with MCI will be recruited by written informed consent using forms approved by the Baylor IRB. Subjects will stop nonvitamin supplements for 4wks before screening labs (blood count, HbA1c, glucose, lipid profile, liver profile, blood urea nitrogen, Creatinine, thyroid stimulating hormone, free T4), and for the entire 24wks duration of the study. 60 fasted subjects will have the following measures before and after 12wks of supplementation with cysteine (as N-acetylcysteine) plus glycine vs alanine: (1) Cognitive function using ADCS-PACC (Alzheimer's Disease Co-operative Study-Preclinical Alzheimer's Cognitive Composite which includes Free and Cued Selective Reminding Test, Immediate and Delayed paragraph recall score, Digit-Symbol Substitution Test, Mini mental state examination; (2) Red-cell concentrations of GSH, cysteine, glycine, glutamic acid; plasma malondialdehyde, F2/F3-isoprostanes, sICAM, sVCAM, E-selectin; endothelial function; (3) Mitochondrial glucose oxidation by calorimetry. Measures will be repeated for washout effects 12-wks after stopping supplements.

Eligibility Criteria:
Inclusion Criteria at study entry: (1) Diagnosis of Mild Cognitive Impairment Exclusion Criteria at study entry: (1) hospitalization within past 3 months; (2) known diabetes; (3) creatinine greater than or equal to 1.5 mg/dL; (4) hemoglobin concentration less than 11 g/dL; (5) known liver disease, or AST/ALT greater than or equal to 2x ULN; (6) history of stroke, brain tumor, or active heart failure; (7) history of psychiatric disorders; (8) untreated depression.
Safety and Effectiveness of Zintevir (AR177) Given to HIV-Infected Patients

The purpose of this study is to see if it is safe and effective to give zintevir (AR177) to asymptomatic (no symptoms) HIV-infected patients.

Zintevir belongs to a new class of anti-HIV drugs, the integrase inhibitors. HIV uses the protein integrase to infect a cell. Integrase inhibitors block integrase and may stop replication of HIV.

Zintevir belongs to a new class of anti-HIV drugs, the integrase inhibitors. The HIV-1 virus uses the protein integrase to incorporate its genetic material into the infected host cell. Integrase inhibitors block integrase and may stop replication of the HIV-1 virus.

In this open-label, Phase I/II study, 3 groups of HIV-positive patients (12 patients total) receive escalating doses of intravenous zintevir for 14 consecutive days.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive, but do not have any symptoms of HIV infection.
* Have a CD4 count greater than 200 cells/mm3.
* Have a viral load (level of HIV in the body) greater than 4,000 copies/ml.
* Are at least 18 years old.

Exclusion Criteria

You will not be eligible for this study if you:

* Tend to have abnormal bleeding or other blood problems.
* Have an active AIDS-defining illness.
* Have a history of serious disease or illness.
* Abuse alcohol or drugs.
* Have received certain medications.
Internet App to Self-Manage Occasional Low Back Pain

Nonspecific low back pain (NLBP) is the diagnosis for 85% of low back pain sufferers with no underlying medical cause (e.g., herniated disc, spinal stenosis) that requires physician care. Treatment, however, is impractical for many physicians to implement during office visits, and there are relatively few providers for NLBP treatment that follow national pain control guidelines. This study evaluated the efficacy of an on-line intervention using desktop computers or mobile technology to help users self treat NLBP occurrences and to engage in activities to decrease future occurences.

Methods. A total of 606 adults, 18 years of age and older were recruited, screened, and consented online. They were assessed on-line at baseline, at two months weeks, and at four months After the baseline assessments, participants were randomized into NLBP treatment (TX), alternative website control (AWC), and no-contact control groups. The TX and AWC groups received 8 weekly emails prompt to visit their respective experimental websites.

Add Details here.

Eligibility Criteria:
Inclusion Criteria:

* suffered low back pain in previous 3 months
* employed or family of employee

Exclusion Criteria:

* on-going medical care for low back pain
* positive response to questions about symptoms which medically disqualify potential participant
Alberta Clinical Trial in Optimizing Hypertension

The purpose of this study is to evaluate the effect of enhanced pharmacist care (patient identification, assessment, education, prescribing/titration of antihypertensive medications and close follow-up) on systolic blood pressure (BP) reduction in patients with poorly controlled hypertension in the community setting.

The study is a randomized, controlled trial of enhanced pharmacist care, with the unit of randomization as the patient. Participants will be randomized to enhanced pharmacist care (patient identification, assessment, education, close follow-up and prescribing/titration of antihypertensive medications or usual care. Participants will be patients in Alberta with undiagnosed or uncontrolled BP as defined by the Canadian Hypertension Education Program. The primary intervention will be enhanced pharmacist care. Pharmacists will assess patients with regards to cardiovascular risk reduction including reviewing BP control, treatment goals and determining lifestyle modifications for the patient to undertake to help manage their BP. The primary outcome will be a comparison of difference in change in systolic BP between enhanced care and usual care at 24 weeks follow-up. Secondary outcomes include the number of patients at their BP target at 24 weeks, number of new antihypertensive medication starts, number of antihypertensive dosage changes, number of antihypertensive medication changes and number of new prescriptions for ASA and cholesterol medications.

Eligibility Criteria:
Inclusion Criteria:

1. Overall average (after 2 visits) systolic ≥180 OR diastolic ≥110 mmHg in undiagnosed patients without macrovascular target organ damage, diabetes or chronic kidney disease
2. Overall average (after 2 visits) systolic ≥140 OR diastolic ≥90 for patients with undiagnosed hypertension with macrovascular target organ damage (coronary artery disease, cerebrovascular disease, DM)
3. In patients with diagnosed hypertension, systolic ≥140 (≥ 130 with DM or CKD) OR diastolic ≥90, (≥ 80 with DM or CKD)
4. Overall average (after 5 visits, for those without macrovascular target organ damage, DM, or CKD and without an existing hypertension diagnosis) systolic ≥140 OR diastolic ≥90 mmHg
5. Overall average (after 7 days of twice-daily home blood pressure monitoring , for those without macrovascular target organ damage, DM, or CKD and without an existing hypertension diagnosis) systolic ≥135 OR diastolic ≥85

Exclusion Criteria:

* Patients with hypertensive urgency or emergency:

  * Urgency: SBP ≥ 180 mm Hg or DBP ≥ 120 mm Hg with no acute signs of end-organ damage
* Unwilling to participate/sign consent form
* Pregnancy
SIRT or TACE Plus Lenvatinib and PD-(L)1 Inhibitor in High Burden HCC

This multicenter retrospective study evaluated the efficacy and safety of selective internal radiation therapy (SIRT) combined with lenvatinib and PD-(L)1 inhibitors (SIRT-L-P) versus transarterial chemoembolization (TACE) combined with lenvatinib and PD-(L)1 inhibitors (TACE-L-P) in patients with HCC beyond up-to-seven criteria or with portal vein tumor thrombus (PVTT). Tumor response, progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were compared between the two groups.

Consecutive patients with HCC beyond up-to-seven criteria or with PVTT treated with SIRT-L-P or TACE-L-P from June 2022 to October 2024 were screened. Tumor response was evaluated according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) and Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Clinical outcomes, including tumor response, PFS, OS, and AEs were compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* histologically or clinically confirmed diagnosis of HCC at BCLC stage B or C (extrahepatic metastases were allowed)
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
* Child-Pugh class A or B7
* unresectable HCC with intrahepatic tumor beyond up-to-seven criteria and/or with PVTT.

Exclusion Criteria:

* receipt of other loco-regional therapies, including hepatic arterial infusion chemotherapy, external radiation therapy, or radioactive seed implantation
* Prior systemic therapy
* History of other malignancies
* incomplete medical records
The Pharmacokinetics and Effectiveness of Local LevoBupivacaine Injection on Primary Total Joint Replacement Model.

Total joint replacement is an ideal procedure to treat end stage joint disease. Good post-op pain relief could accelerate patient recovery and rehabilitation, and decrease admission days and medical cost. Local injection of LevoBupivacaine is an effective method in post-operative pain control. The effectiveness of local analgesia was noticed clinically. However, thorough studies about the pharmacokinetics of LevoBupivacaine, maintenance of effect, influence of post-operative rehabilitation are not well studied in different way of injection. The purpose of this study is to evaluate and analyze the pharmacokinetics and effect of local Levobupivacaine injection in different ways, the amount of post-operative fentanyl requirement after local injection, time to first fentanyl request, pain score, immediate post-operative function, side effect of analgesic agents, and medical cost, and to improve the quality of total joint replacement post-operative care.

Single large dose of LevoBupivacaine had been proved good analgesic effect in total joint replacement surgery. However, the safety was not well studied. For better understanding the effect and safety of local analgesic agent, we choose LevoBupivacaine with different injection way to find out. We divide patient to three groups, for comparing the effectiveness of LevoBupivacaine, and safety of LevoBupivacaine by checking intra-blood concentration. The pre-emptive analgesics and post-operative analgesics were the same as routine protocol in other total joint replacement.

Eligibility Criteria:
Inclusion Criteria:

1. Primary total joint replacement, no previous open surgery on the same joint
2. Age 50\~80 y/o, Pre-operative diagnosis: degenerative osteoarthritis
3. Pre-operative deformity: varus \<15°, valgus \<15°, flexion contracture \<15°.
4. Patients with normal heart function
5. Willing to receive post-operative questionnaire and outpatient clinic follow-up

Exclusion Criteria:

1. Allergy to Patient-Controlled Analgesia or LevoBupivacaine
2. Mental or cognitive illness that couldn't well response to questionnaire
3. American Society Anesthesiologist more than III degree
4. Liver cirrhosis, chronic renal insufficiency, heart disease or arrhythmia, insulin-dependent diabetes mellitus, and previous narcotic abuse history.
5. Not suitable for using patient-controlled analgesia pump by evaluation of anesthesiologist
Effect of Posture on Left Ventricular (LV) Transvenous Lead Capture Thresholds (EXPECT)

The purpose of this study is to determine whether changes in a patient's position affect LV capture thresholds in a clinically significant way.

Traditionally clinicians program the safety margins for the right atrial, right ventricular, and left ventricular leads two-times the capture thresholds. This safety margin is necessary for the right atrial and right ventricular outputs to prevent asystole during fluctuation of capture thresholds. This two-times safety margin may not be necessary for the left ventricular lead output and may be causing shorter device battery longevity. Newly implemented LV capture threshold management algorithms may help maintain a proper balance of safety margin and battery longevity. However, recent research conducted on automatic left ventricular capture measurement (LVCM) shows as much as 3.5 V daily variability in capture thresholds. In this same study, 18% of patients had \>1.5 V LV threshold variability. A possible explanation for the variability of LV thresholds is lead stability. Small movements of the lead electrodes associated with movement of patient posture may account for daily fluctuation of capture thresholds. As heart failure patient care and therapies improve, CRT patients may survive longer than the projected longevities of their device. In order to minimize patient risks associated with device change-outs, care must be taken to maximize battery longevity while maintaining CRT pacing. Examining patient posture changes as a possible cause of threshold variability may guide clinicians to program more appropriate LV outputs with patient safety and device longevity in mind.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years of age and able to provide informed consent
* Planned placement of a Medtronic LV pacing lead and a Medtronic ICD generator with LVCM technology
* Geographically stable and able to follow-up for a period of at least six months post-procedure at The Heart Hospital Baylor Plano
* Willingness to comply with the requirements of the protocol

Exclusion Criteria:

* Life expectancy of less than six months
* Plans for or significant possibility of pregnancy during the required follow-up window
* Significant cardiovascular surgery planned within six months following ICD implant
Applicability of Video Games and Vibrational Therapy in Reducing Pain Secondary to Breast Cancer

To evaluate the influence of virtual reality and vibrational therapy in reducing pain intensity secondary to breast cancer before and after application of treatment protocols, through biomedical instrumentation.

After physiotherapy assessment individuals will be randomly divided into three groups: Group Virtual Reality - Cinesioterapia (G1), Group Vibration Therapy - Cinesioterapia (G2) and Control Group (G3), which will be submitted to the respective treatment protocols. Group Virtual Reality Cinesioterapia (G1) participate in this group 20 women will be treated through the games Xbox 360 ®, attributed to this, customized applications using virtual and augmented reality to be developed. Vibration Therapy Group - Cinesioterapia (G2) - will participate in this group 20 women who will undergo 15 minutes of continuous vibration through the blanket vibrating members higher, with frequency 40 Hz, 3 function and intensity tolerable, keeping the limb supported and elevated to 120 º. At the end held muscle stretching exercises, dissociation of shoulder girdle and upper limb exercises assets. Control group (G3) - participate in this group 20 women who are treated with conventional cinesioterapia through muscle stretching exercises for flexors, extensors, adductors and abductors shoulder for 20 seconds each; dissociation girdle; financial assets and Active assisted for groups flexors, extensors, abductors and adductors of the upper limbs, which will be performed three sets of 10 repetitions for each exercise. Implementation of treatment protocols for the groups G1, G2 and G3 will run for two weeks, being Monday through Friday feira.totalizando 10 consecutive treatment sessions lasting 30 minutes each session. You will be prompted to patients groups G1, G2 and G3 to respond individually and without any aid the visual numeric scale of pain, 10 minutes pre-therapy, 15 minutes after the start and 10 minutes after the end of therapy. Patients will undergo the assessment of pain, electromyographic activity of muscles, muscle strength, range of motion analysis and perimetry in the first day of treatment, and after completing all the sessions patients were reassessed.

Eligibility Criteria:
Inclusion Criteria:

* Women who underwent surgery for unilateral mastectomy and axillary lymphadenectomy modified in a period exceeding one year;
* Submit medical referral;
* Which are not performing radiotherapy or chemotherapy;
* Age 40-70 years;
* Reporting pain, intermittent, prolonged duration and intensity that limits the ADL;
* Lymphedema in the ipsilateral upper limb surgery;
* To agree and sign the Statement of Consent

Exclusion Criteria:

* Individuals who fail to provide medical referral;
* Be a carrier of other types of cancer;
* Have undergone other types of surgery removal of breast cancer; - be doing chemotherapy or radiotherapy;
* Do not complain of pain symptoms and lymphedema;
* Presenting severe joint lock.
Turmeric and Curcumin on Sebum Production

A noticeably increasing number of patients are asking for naturally based extracts and ingredients as supplementary dermatologic remedies. Patients are seeking natural and cost-effective skin care alternatives in place of prescription medications and procedures. Our study will evaluate the effects of oral curcumin and turmeric on sebum production in healthy subjects.

Turmeric extracts and curcumin have been shown to be safe, even at high doses without significant side-effects. Previous clinical studies in other inflammatory skin diseases have shown that a dosage of curcumin at 6,000 mg daily was effective while lower doses were not. In a human phase I clinical trial examining the effects of high dose curcumin in preventing premalignant lesions, even curcumin doses as high as 8,000 mg/day resulted in no toxic effects after 3 months. This study will involve participant ingestion of 6,000 mg/day of turmeric or curcumin to assess how this affects their sebum production.

The investigators will also be collecting stool from the study subjects, and examining how the curcumin and turmeric may modulate their gut microbiome. The investigators will specifically be looking to see if curcumin or turmeric have any changes on the gut flora towards bacteria that produce more short chain fatty acids. Certain bacteria that make up the microbiome produce short chain fatty acids, such as butyrate and propionate, which have demonstrated anti-inflammatory properties. Thus, it would be interesting to see if turmeric or curcumin exert any of its anti-inflammatory effects via modulation of the microbiome.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 50 years of age, and
2. Subject must be able to read and comprehend study procedures and consent forms.

Exclusion Criteria:

1. Subject should be generally healthy and have no smoking history in the past one year, and must have no history of diabetes, metabolic syndrome, known cardiovascular disease, malignancy, kidney disease, or chronic steroid use.
2. Those who used topical medications in the past two weeks or systemic antibiotics or oral probiotics within one month of starting the study.
3. Subjects who are postmenopausal
4. Those who are pregnant or breastfeeding.
5. Those that are prisoners or cognitively impaired.
6. Those who have a known allergy to black pepper should not participate in this clinical trial, since one of the treatments consists of tablets containing a small amount (1.25mg/tablet) of black pepper.
7. Those that are taking angiotensin converting enzyme inhibitor medications or angiotensin receptor blocker medications for any reason.
School Inner City Air Study

The goal of this randomized clinical trial is to test the efficacy of high efficiency particulate air (HEPA) cleaners in reducing respiratory viral exposure and infections in elementary school classrooms. Classrooms will be randomized to active vs. sham HEPA cleaners. The main questions it aims to answer are:

* Do classroom HEPA cleaners reduce exposure to viruses?
* Do classroom HEPA cleaners reduce student and teacher infections?
* Do classroom HEPA cleaners reduce infections in family members?

Classrooms from participating schools will be randomized to active vs. sham HEPA cleaners. From enrolled classrooms, we will enroll students, teachers, and members of the household. We will collect the following:

* longitudinal classroom air samples
* longitudinal upper respiratory samples
* longitudinal symptom surveys using the Wisconsin Upper Respiratory Symptom Survey (WURSS) Viral testing on collected air and respiratory samples will be performed using digital polymerase chain reaction (dPCR).

Eligibility Criteria:
Inclusion Criteria:

Children

* Grades K-5 (age 6-12 years)
* Attend one of the schools that the study team has permission to obtain classroom/school environmental samples
* Have no plans to move schools within the upcoming 12 months
* Subject and/or parent guardian must be able to understand and provide informed consent and also willing to participate in the study

Adults

* Adult (age 21 or older) parent, caretaker, or household member of child participating in this study, or teacher in classroom participating in study
* Able to understand and provide informed consent

Exclusion Criteria:

Children

* Contraindication to or inability to participate in home self-collection of nasal swab samples
* Severe chronic diseases (e.g. cancer, genetic or congenital disorders interfering with mobility)
* Severe neurobehavioral, neurodevelopmental or psychiatric disorders requiring special assistance
* Families who do not speak English or Spanish well enough to complete the survey questions, as validated versions in other languages are not available for all of the measures

Adults

* Contraindication to or inability to participate in home self-collection of nasal swab samples
* Severe chronic diseases (e.g. cancer, genetic or congenital disorders interfering with mobility)
* Severe neurobehavioral, neurodevelopmental or psychiatric disorders requiring special assistance
* Families who do not speak English or Spanish well enough to complete the survey questions, as validated versions in other languages are not available for all of the measures
Serum and Peritoneal Fluid Bank for Endometriosis Markers

The purpose of this study is to investigate differences in protein expression profiles of blood and peritoneal fluid samples obtained from patients who do, and those who do not, have endometriosis seen during laparoscopic surgery. These profiles may include both known and novel markers for diagnosing endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing laparoscopic surgery for one of the following indications:

  1. infertility
  2. pain
  3. tubal sterilization
* For cases, visualization of endometriosis
* For controls, absence of endometriosis

Exclusion Criteria:

* None
Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease

The use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn's disease. However, due to limited clinical data, this multicentre, nationwide study aimed to assess its clinical efficacy in closing complex anal fistula.

Fifteen applications in 14 patients (3 male, 11 female) with complex anal fistulas treated in three tertiary hospitals in Austria were included between October 2018 and April 2021. Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells (Cx601 - Darvadstrocel, Alofisel®) was performed in each patient. Closure of the external fistula opening without secretion by finger compression was defined as success.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 and older who had a non-active or mildly active luminal CD with complex fistula with a maximum of two internal and three external fistulas

Exclusion Criteria:

* rectovaginal fistulas
* rectal and/or anal stenosis
* active proctitis
* diverting stomas
* an abscess (\<2cm) that was not drained at the fistula preperation visit