cyrilzakka/clinical-trials huggingface dataset:
Improving Prognosis in HIV Infection

The primary objective of this study is to assess the safety of probiotics in cART-treated immunologic non-responder (INR) patients with chronic HIV infection.

The secondary objectives are to i) explore the biological effects of probiotics in combined antiretroviral therapy(cART)-treated INR patient with chronic HIV infection, and ii) investigate differences between cART-treated HIV-infected INR and non-INR patients with regards to gut microbial composition and mucosal barrier function.


Eligibility Criteria:
Inclusion Criteria:

* HIV seropositive \>4 years.
* Continuous combined antiretroviral treatment (cART) \>4 years.
* Plasma HIV RNA \<50 copies/mL \>3,5 years.
* Cluster of differentiation(CD)4+ T cell count \<400 cells/µL (OR \>600 cells/µl) \>3.5 years.
* Caucasian
* Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to International Committee on Harmonization (ICH) Good Clinical Practice (GCP), and national/local regulations.

Exclusion Criteria:

* Plasma hepatitis C (HCV) RNA positive.
* Serum hepatitis B surface antigen (HBsAg) positive.
* Comorbidity of inflammatory bowel disease, coeliac disease or malnutrition.
* Concomitant use of non-steroid anti-inflammatory drugs (NSAID), corticosteroids, disease-modifying antirheumatic drugs, or other anti-inflammatory pharmaceutical substances.
* Concomitant use of antithrombotic pharmaceutical substances
* Regular (weekly) use of any probiotic substance within 3 months prior to inclusion.
* Use of antibiotics within 3 months prior to inclusion.
* Deranged liver function (serum albumin \<25 g/L or Child-Pugh ≥10)
* Renal failure (estimated glomerular filtration rate (eGFR) \<30 ml/min)
* Heart failure (NYHA class II-IV)
* Intolerance to milk or phenylalanine
* Any reason why, in the opinion of the investigator, the patient should not participate
Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence

Buprenorphine (BPN) is an approved treatment for opioid dependence, however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low. Probuphine is an implant placed just beneath the skin that contains BPN. It is designed to provide 6 months of stable BPN blood levels. This study will test the safety and efficacy of Probuphine in the treatment of patients with opioid dependence.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily provide written informed consent prior to the conduct of any study related procedures
* Male or female, 18-65 years of age
* Meet DSM-IV criteria for current opioid dependence
* Females of childbearing potential and fertile males must use a reliable means of contraception

Exclusion Criteria:

* Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS)
* Presence of aspartate aminotransferase (AST) levels ≥ 3 X upper limit of normal and/or alanine aminotransferase (ALT) levels ≥ 3 X upper limit of normal and/or total bilirubin ≥ 1.5 X upper limit of normal and/or creatinine ≥ 1.5 X upper limit of normal
* Received treatment for opioid dependence (e.g., methadone, BPN), within the previous 90 days
* Current diagnosis of chronic pain requiring opioids for treatment
* Candidates for only short term opioid treatment or opioid detoxification therapy
* Pregnant or lactating females
* Previous hypersensitivity or allergy to BPN- or EVA-containing substances or naloxone
* Current use of agents metabolized through CYP 3A4 such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), and protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)
* Current anti-coagulant therapy (such as warfarin) or an INR \> 1.2
* Meet DSM-IV criteria for current dependence on any other psychoactive substances other than opioids or nicotine (e.g., alcohol, sedatives)
* Current use of benzodiazepines other than physician prescribed use
* Significant medical or psychiatric symptoms or dementia which in the opinion of the Investigators would preclude compliance with the protocol, patient safety, adequate cooperation in the study, or obtaining informed consent
* Concurrent medical conditions (such as severe respiratory insufficiency) that may prevent the patient from safely participating in study; and/or any pending legal action that could prohibit participation and/or compliance in study
* Participated in a clinical study within the previous 8 weeks
Two Methods of Diagnosing Preterm Labor

Use of modern diagnostic tools e.g. fetal fibronectin and ultrasound measurement of cervical length to diagnose preterm labor can result in improved outcomes compared to traditional diagnosis based on digital examination to measure cervical change.

Symptomatic preterm labor patients will be randomized to diagnosis of preterm labor by serial digital examination versus an algorithm incorporating transvaginal ultrasound measurement of cervical length and vaginal fetal fibronectin.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic complaints suggestive of preterm labor
* greater than 6 contractions per hour

Exclusion Criteria:

* multiple gestation
* rupture of amniotic membranes
* chorioamnionitis
* congenital malformations
* persistent vaginal bleeding
* abruptio placentae
* placenta previa
* previously diagnosed short cervix \< 2.5 cm
* cervical dilation \> 3 cm
* cervical cerclage
* exposure to tocolytic drugs
* allergy or contraindication to nifedipine
Imaging Study Compare 4DCT Image

The goal of this clinical research study is to learn about ways to possibly reduce scanning errors when using 4-dimensional computed tomography (4D CT) scans to check lung function in patients with esophageal or lung cancer.

Study Procedure:

By using 4D CT scans, researchers can create images that show how air moves through the lungs. This new method to check lung function may make better images than the standard methods. Researchers will compare 4 images of how air moves through your lungs and 1 image while you hold your breath.

Study Groups:

If you are found to be eligible to take part in this study (if the screening test is applicable) and you agree to take part in this study, you will be enrolled in 1 of 2 study groups, depending on when you join the study. There will be up to 18 participants in each group. In the first group, researchers will test several different methods to create images of how air moves through the lungs. Researchers will then select the most successful methods from the first group and try to do them again with the second group.

Study Visits:

You will have up to two visits for this study. At these visits, you will have four 4DCT scans performed (for Group 1) or five scans (for Group 2) using both the 4DCT and spiral CT, while you are breathing normally. You will also have 1 scan while you hold your breath for less than 20 seconds. The CT scans will take about 5 minutes each to complete. If the spiral CT scans for Group 2 cannot be completed on the same day as the 4DCT scans, you will be asked for your willingness to return at a later day to complete these.

The 4D CT scan will cover the entire chest area using the standard dose of radiation. A 2-inch plastic box will be placed on top of your chest to track the motion of your chest while you breathe during each scan. Some parts of your chest will be scanned up to 2 more times based on your breathing.

The entire scanning session will take about 45 minutes to complete.

Length of Participation:

Your active participation on the study will be over when you have completed your study visit.

Follow-Up Phone Call:

Within 7 days after your last study visit, the study staff will call you to ask about any side effects you may be having. This call should last about 2 minutes.

If anything unusual is found in the imaging, your cancer doctor will be told so that you can receive follow-up.

This is an investigational study. The CT scans used in this study are delivered using FDA-approved and commercially available systems. Creating images of how air moves through the lungs from 4D CT scans is considered investigational.

Up to 36 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must sign consent for the study.
2. Patients with pathologic diagnosis of esophagus or lung cancer.
3. Patient who plan to receive radiation therapy treatment at MD Anderson.
4. Patient \>/=18 years of age

Exclusion Criteria:

1. Presence of an implanted electronic device.
2. Women who are pregnant or lactating, due to possible adverse effects on the developing fetus or infant.
Metabolic Effects of Steroids in Obese Men

Subjects will be randomized into 4 study groups: 1. Placebo; 2. Anastrazole and Testosterone; 3. Dutasteride and Testosterone; and 4. Testosterone only. A 2 step euglycemic clamp, body composition by dual X-ray absorptiometry scan, hormone and lipid assays will be performed to monitor metabolic effects of each treatment group. We hypothesize that increasing testosterone levels would increase lean mass, decrease fat mass and improve insulin sensitivity. We further hypothesize that improvements in the metabolic profile would decrease with anastrazole and improve with dutasteride, given in conjunction with T administration.


Eligibility Criteria:
Inclusion Criteria:

* free T level in the lower 25% of the normal range or below
* BMI ≥30kg/m2
* waist circumference ≥100cm

Exclusion Criteria:

* pituitary tumors
* HIV infection
* Klinefelter's syndrome
* Kallman's syndrome
* uncontrolled hypertension
* diabetes
* congestive heart failure
* chronic lung disease
* acute coronary syndrome
* PSA \>4µg/L
* aspartate aminotransferase (AST)\> 3x upper limit of normal
* use of medications that might affect weight loss, muscle or bone metabolism or androgen metabolism, action or clearance.
* involvement in daily resistance training or high endurance exercise
* alcohol or drug dependence
* obstructive sleep apnea
AZD6765 Severe Major Depressive Disorder (MDD) IV

The purpose of this research study is to determine whether AZD6765 has an effect on the patient's depression when taken together with current depression medication. In addition, information will be gathered on how well AZD6765 is tolerated, investigate the levels of AZD6765 and the levels of the current depression medication in the blood. In addition, the research staff will determine if AZD6765 has any mood or calming effects (how you feel).


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent before any study-related procedures start.
* The patient is previously diagnosed with Major Depressive Disorder (MDD) and currently taking an antidepressant for at least 6 weeks.
* Patient has a history of poor response to 1 or more antidepressants (in addition to the antidepressant the patient is taking at enrollment) after exposure at adequate doses or maximum tolerated doses for ≥4 weeks.

Exclusion Criteria:

* Patient has a lifetime history of schizophrenia, bipolar, psychosis or psychotic depression.
* Patient has a lifetime history of failure to ECT therapy.
* Patient is pregnant or breast feeding.
* Length of current episode of depression exceeds ≥2 years.
Anxiety, Depression, and Quality of Life in Patients With Fibromyalgia During the Coronavirus Disease 2019 Pandemic

Fibromyalgia patients and controls living in the same household will be evaluated for levels of resilience, covid-19 related anxiety, coronavirus disease 2019 related obsession, quality of life and pain and comparisons and correlation analyses will be carried out.

Fibromyalgia is a generalized pain condition that is accompanied by sleep disturbances, anxiety, depression and somatic symptoms. During Coronavirus disease 2019 pandemic, fibromyalgia patients as well as the general population have increased anxiety levels. This study was planned to evaluate fibromyalgia patients' levels of coronavirus disease 2019 related resilience, anxiety, obsession levels about coronavirus disease 2019, quality of life and pain levels and compare them with healthy controls living in the same household.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of fibromyalgia according to the American college of rheumatology 2016 classification criteria
* Older than 18 years of age

Exclusion Criteria:

* Illiteracy
* A history of coronavirus disease 2019 infection in the last month
* Change in medication to treat fibromyalgia in the last 3 months
* Living alone (lack of a control subject)
* Severe neurological or psychiatric disorder that might hinder subjects' ability to answer the study questions
Clinical Trial for the Application of Robotic System in Spinal Surgery

This randomized controlled study was designed to evaluate the accuracy, safety and clinical outcomes of the robot assisted spinal surgery.

Robot assisted operation is new for spinal surgery, in this study, we will evaluate the accuracy, safety and clinical outcomes compared with traditional free hand operation and navigation assisted operation.

Eligibility Criteria:
Inclusion Criteria:

* Spinal disease required for screw fixation；signed the inform consent

Exclusion Criteria:

* Patients with severe osteoporosis; patients with old fractures; patients with pedicle deformity; patients with severe systemic diseases; patients with coagulation disorders; patients who are considered unsuitable for this trail by the clinician.
Miscarriage Preventing Herbal Medicines and the Risk of Birth Defects: a Population-based Cohort Study

Using data from a population-based medicine use cohort in Xiamen, China, this retrospective cohort study will investigate whether herbal medicines used to prevent miscarriage are associated with increased risk of birth defects.

Herbal medicines have a long history of use for pregnant women both in China and around the world. However, the safety of herbal medicines used at the early gestation is often questioned regarding their impact on offspring. Therefore, the aim of this study is to investigate whether miscarriage preventing herbal medicines associated with increased risk of birth defects.

A large medication use cohort will be developed by linking a population-based pregnancy registry (i.e., REPRESENT) and a population-based pharmacy database, which documented all prescriptions at both outpatients and inpatients from conception to delivery. This cohort will include herbal medicines formula which were granted approval by the Chinese National Medical Products Administration.

Using data from this cohort, the investigators will investigate the prevalence of the use of herbal medicine formulas and prescription patterns at the first trimester. This study will then investigate the association between miscarriage preventing herbal medicines and the risk of birth defects. A propensity score matching (PSM) based Poisson regression will be used to estimate the relative risk. To ensure the robustness of the results investigators will perform several sensitivity analyses and negative control analyses, such as restricting the population to women with singleton pregnancies, excluding individuals who had undergone in vitro fertilization (IVF), and considering those women who were prescribed herbal medicines during the middle and late stages of pregnancy as the negative exposure control group.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancies registered at REPRESENT and underwent live births between January 2013 and December 2018 were included.

Exclusion Criteria:

* (1) those with the first antenatal visit occurring after 20 gestational weeks, (2) those without timing records of the last menstrual period or delivery dates, (3) those with known factors related to birth defects (e.g.,syphilis positive, epilepsy), (4) those prescribed known medications associated with birth defects (e.g.,dezocine, diazepam).
Integrating Design Thinking Into Undergraduate Nursing Education

Previous studies have demonstrated that design thinking workshops can indeed produce these effects in healthcare education settings. However, its effectiveness in nursing curriculum is inconclusive. This research project aims to introduce and integrate design thinking principles into the undergraduate nursing program at the Chinese University of Hong Kong (CUHK), the Nethersole School of Nursing. By implementing a comprehensive study encompassing desktop research, a 3-hour introductory workshop, and pre- and post-evaluations over a 9-month period, the investigators seek to enhance nursing students' problem-solving skills, empathy, creativity, collaboration, and patient-centered care attitude.

Subjects A group of 50 second-year undergraduate nursing students at CUHK Nethersole School of Nursing who volunteer to participate in the research. Participants will be randomly assigned to either: i) Intervention group (n=25): Receives the design thinking workshop; ii) Control group (n=25): Receives no intervention (continues with regular curriculum). According to Hertzog (2008), a minimum of 25 subjects per group would be considered sufficient for the purposes of pilot testing. Students who have prior experience in joining design thinking workshop will be excluded.

Methodology This study employs a pilot randomized controlled design to evaluate the impact of a design thinking workshop on undergraduate nursing students' problem-solving abilities and related skills. The methodology encompasses a comprehensive literature review, pre- and post-workshop assessments, and a 3-hour introductory workshop on design thinking principles applied to healthcare challenges.

1. Systematic review and preparation of material A systematic review will be conducted to examine existing applications of design thinking in healthcare education, particularly in nursing, informing workshop curriculum development in terms of content, delivery method and evaluation approach.
2. Pre-Workshop Evaluation An online survey one month before the workshop will be conducted to assess participants' baseline skills and attitudes using validated instruments. These instruments measure problem-solving abilities, empathy, creativity, collaboration, and patient-centered care attitudes.
3. Design Thinking Workshop A 3-hour introductory workshop will cover the five stages of design thinking: Empathize, Define, Ideate, Prototype, and Test. Students will work on scenario of real-world healthcare challenges, and apply design thinking principles to develop innovative solutions.
4. Post-Workshop Evaluation Immediately after the workshop, participants will complete a post-workshop survey using the same instruments as the pre-workshop evaluation, allowing for comparison of scores.

Eligibility Criteria:
Inclusion Criteria:

- Undergraduate nursing students at CUHK Nethersole School of Nursing who volunteer to participate in the research.

Exclusion Criteria:

* Nil
Effectiveness of a Neoprene CMC Joint Orthosis

Patients will be gathered via convenience sample from a hand therapy clinic. They will be provided with a neoprene commercially available orthosis free of charge. Baseline pain and function will be assessed using the VAS and Functional Index of Hand Arthropathies. Four weeks later, pain, function, and patient satisfaction with the device will be gathered using the Quebec User Evaluation of Assistive Technology questionnaire.

Patients with the diagnosis of carpometacarpal osteoarthritis that are receiving hand therapy will be recruited for the study. Baseline measurements will include usual pain over the past week, current pain, and worst pain experienced over the past week using the VAS pain scale. Hand function will be assessed using the Functional Index of Hand Arthropathies measure. The patients will be provided with a free neoprene hand orthosis (Hely and Weber CMC controller). They will be instructed to wear the device as needed for pain. After 1 month, the investigators will call the patient to assess pain, function, and satisfaction with the device using the Quebec User Evaluation of Assistive Technology Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* CMC OA of either thumb with pain

Exclusion Criteria:

* CMC arthroplasty
* recent surgery
* dementia
* no pain at CMC joint
Molecular Mechanisms Characteristics in Systemic Lupus Erythematous Autoimmune Disease

It is well known that the deregulation of immune responses plays a major role in many autoimmune diseases, such as Systemic Lupus Erythematosus (SLE). The main objective of this protocol is to determine whether the expression and/or function of specific molecules are deregulated in the immune cells of patients with SLE. By examining IRF4, IRF5, IBP/Def6, SWAP-70, Rock1, Rock2, and specific signaling molecules involved in the responsiveness to sex hormones, the investigators hypothesize that the deregulation in the expression and function of these molecules will result in abnormalities in the functioning of the immune cells, which is a key factor in autoimmunity.

Peripheral blood lymphocytes from healthy controls and patients with SLE will be collected and compared in order to determine if specific immune cells (IL-17 and IL-21) are deregulated in patients with SLE and if this deregulation affects their functioning. Specifically, immune cells will be isolated from the blood and then subject to scientific testing (QPCR, Western blotting, immunofluorescence assays, ELISA and FACS analysis) to see if the expression and function of these cells is related to the mechanism behind SLE. This will be a case control study, where cases of SLE will be compared to controls of healthy volunteers to assess risk factors. As these healthy volunteers are providing samples solely for research purposes, there is no standard of care for these volunteers, with the exception of a positive HIV result during screening. The Department of Genetic Medicine will enroll healthy controls and the Hospital for Special Surgery will enroll subjects with Systemic Lupus Erythematosus (SLE) for a comparative analysis of the two cohorts. Laboratory testing on all blood samples will be done at the Hospital for Special Surgery.

This will be a case control study, where cases of SLE will be compared to controls of healthy volunteers to assess risk factors. As these healthy volunteers are providing samples solely for research purposes, there is no standard of care for these volunteers, with the exception of a positive HIV result during screening. The Department of Genetic Medicine will enroll healthy controls and the Hospital for Special Surgery will enroll subjects with Systemic Lupus Erythematosus (SLE) for a comparative analysis of the two cohorts (Table I). Laboratory testing on all blood samples will be done at the Hospital for Special Surgery.

Table I. Site Recruitment1

WCMC Healthy Subjects 20 HSS Subjects with SLE 20 Total 40

Eligibility Criteria:
Inclusion Criteria:

* Must provide informed consent
* Males and females, age 18 years and older
* Healthy Nonsmokers

Exclusion Criteria:

If the subject has

* Rheumatic disease
* Diabetes
* SLE or lupus
* Autoimmune disease
* Active infection or pregnancy
* HIV infection