cyrilzakka/clinical-trials huggingface dataset:
The Effect of Acupuncture on Anxiety and Working Memory

This study endeavors to examine the relationship between acupuncture, anxiety, and performance on a test of working memory. In the study, all participants will complete the State-Trait Anxiety Inventory (STAI) survey to determine how anxious they are at the moment and how anxious they tend to be in general. Then ½ of subjects will receive acupuncture for 20 minutes and ½ will rest quietly for 20 minutes. After this period, all subjects will again complete the STAI survey. Then all subjects will complete the Automated Operations Span Task (AOSPAN) which is a computerized test of working memory. Statistical analysis will be performed to determine if acupuncture had any effect on State-level anxiety and on performance on the AOSPAN.


Eligibility Criteria:
Inclusion Criteria:

* Undergraduate University student
* Fluent in English
* Willing to receive acupuncture
* Aged 18-30
* In good health
* Not pregnant
* Not breastfeeding

Exclusion Criteria:

* Not an Undergraduate University student
* Not fluent in English
* Unwilling to receive acupuncture
* Under 18 years of age or older than 30 years of age
* Chronic disease
* Pregnant
* Breastfeeding
CD19-BAFF CAR-T Cells Therapy for Patients With Autoimmune Diseases

Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for Autoimmune Diseases.

In this study, 45 patients with Autoimmune Diseases include Systemic Lupus Erythematosus、Systemic sclerosis、Dermatomyositis、Immune nephritis and Neuromyelitis optica were proposed to undergo CD19-BAFF CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19-BAFF CAR-T cell therapy for Autoimmune Diseases; At the same time, on the basis of expanding the sample size, more safety data on CD19-BAFF CAR-T cell treatment for Autoimmune Diseases were accumulated, including rare and delayed complications.

Eligibility Criteria:
Inclusion Criteria:

* 1. Gender unlimited，18\<Age;
* 2. Diagnosed as Autoimmune Diseases（Systemic Lupus Erythematosus，Immune nephritis, Systemic sclerosis，Dermatomyositis，Neuromyelitis optica）and after routine treatment (using more than 2 types drugs, such as hormones and Immunosuppressants，Immunomodulator or Biological agents) are ineffective for more than 6 months or reappear with disease activity and/or no effective treatment after disease remission
* 3. Estimated life expectancy of minimum of 12 weeks;
* 4. The blood routine meets the following standards:

  1. Lymphocyte count\>0.3×10e9/L;
  2. Neutrophils ≥0.5×10e9/L;
  3. Hemoglobin ≥60g/L;
  4. Platelet ≥30×10e9/L
* 5. Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
* 6.Those who voluntarily participated in this trial and provided informed consent;

Exclusion Criteria:

* 1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
* 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
* 3.Pregnant or lactating women (the safety of this therapy for unborn children is still unknown)
* 4. Patients with HIV infection
* 5. Active infection of hepatitis B virus or hepatitis C virus;
* 6. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
* 7. Creatinine\>176.8 umol/L, or ALT / AST \> 3 times of normal amounts, or bilirubin\>51 umol/L;
* 8. Any unsuitable to participate in this trial judged by the investigator;
* 9. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 3 months;
* 10. Received immunosuppressive therapy within one week prior to mononuclear cell collection；
* 11. ndividuals who have used systemic steroid drugs exceeding 20mg/d of prednisone or equivalent doses within one week prior to treatment (excluding those who have recently or are currently using inhaled steroids)；
* 12. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.
COHORT Trial in Clinical Pelivc Lymph Node Metastatic Prostate Cancer

In local advanced prostate cancer patients with clinically positive metastatic regional lymph node, the optimal treatment is still unanswered. For these patients, radiotherapy combined with hormonal therapy or hormonal therapy alone are recommended. Recently, the reports from NCCB and SEER data showed that radiotherapy combined with hormonal therapy have better survivals than hormonal therapy alone.

This randomized phase III trial compare hormonal therapy alone with combined hormone with radiotherapy in clinically pelvic lymph node metastatic prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* pathologically confirmed prostate cancer within 6 months for study enrollment
* Clincally enlarged pelvic lymph node ((short axis 0.5 cm ≤) in imaging studies (CT, MRI, PET-CT) at diagnosis and partial response or complete remission of enlarged lymph nodes according to RECIST v1.1 after hormonal therapy for 2-3 months 3. age 20 ≤ 4. ECOG performance status 0-1 5. Optimal hematologic profiles within 6 months for study enrollment
* Absolute neutrophil count (ANC) ≥ 1500 cells/mm3
* Platelets ≥ 50,000 cells/mm3
* Hemoglobin ≥ 8.0 g/dl 6. Optimal kidney function within 6 months for study enrollment
* Creatinine \< 2.0 ng/dL 7. Optimal liver functions within 6 months for study enrollment
* total bilirubin \< 1.5 X maximum normal value
* alanine aminotransferase or aspartate aminotransferase \< 2.5 X maximum normal value

Exclusion Criteria:

1. combined with distant metastasis (retroperitoneal lymph node, bone,...)
2. previous history of antiandrogen therapy within 6 months of study enrollment
3. previous history of definitive prostate cancer treatment such as prostatectomy
4. previous history of pelvic radiotherapy
5. previous history of other cancer treatment except for skin cancer and theroid cancer
Registry for Advanced Endoscopy

Observational registry including endoscopic diagnostic and therapeutic interventions in the gastrointestinal tract


Eligibility Criteria:
Inclusion Criteria:

* Clinical indication for endoscopic intervention/procedure

Exclusion Criteria:

* No informed consent
* Age \<18 years
Effectiveness of a Web-based Intervention on Parental Psychological Flexibility and Emotion Regulation

This project aims to validate a web-based clinical intervention for families with children suffering neurodevelopmental or behavioral disorders to promote psychological flexibility and emotion regulation strategies in parents.

Family context, and specifically parents' educational styles (PE) can act as a protective or risk factor for the maintenance and development of various disorders in childhood. When the child is diagnosed of a disease, disorder or difficulty, parents can develop a series of beliefs that will mediate their PEs, their barriers and their emotional repertoire. It can worsen the family climate, lead to maladaptive behaviors, and finally, lead to difficulties in adherence to treatment due to possible avoidance patterns. Several studies indicate that these patterns are mediated by a regulation of dysfunctional emotions in parents by not tolerating the discomfort caused by the suffering of their children.

This project aims to validate a web-based clinical intervention for families with children suffering neurodevelopmental or behavioral disorders to promote psychological flexibility and emotion regulation strategies in parents. Clinical intervention is focused in improving emotion regulation and positive parenting strategies using third-wave/contextual therapies. The intervention consist in 6 sessions with a duration of 1.5 hours. This study compare a a face-to-face parenting intervention group with a web-based parenting intervention. The first hypothesis is that both parental interventions will improve the educational styles, emotional competencies and well-being of parents in pos-test and 3-month follow up assessment. Second, web-based intervention will be more efficient in comparison with face-to-face intervention.

Eligibility Criteria:
Inclusion Criteria:

A. Be a parent/guardian of a child between 0 and 12 years old. B. Be a parent/guardian of a child who obtains a limit score on any of the scales of the Difficulties and Capabilities Questionnaire (SDQ).

C. Obtain a high score in parental inflexibility / emotional distress through the Parental Acceptance Questionnaire in any of its subscales.

D. Parents/guardians have a device that provides access to the web-based intervention.

E. They agree to participate in the study by signing the informed consent

Exclusion Criteria:

A. The parent/guardian is in a process of separation or negligent parenting, this aspect will be assessed from a clinical trial in the initial interview.

B. The parent/guardian has serious psychological or substance use problems or disorders that may hinder their participation in the study.

C. The parent/guardian presents Spanish comprehension barriers.
Immunoadsorption vs. Plasmapheresis in the Escalation Therapy of Relapse in Multiple Sclerosis

This observational study investigates the efficacy and safety of immunoadsorption versus plasmapheresis in 60 patients with relapse in Multiple Sclerosis and Clinically isolated syndrome who do not fully recover after a high doses of intravenous corticosteroids.


Eligibility Criteria:
Inclusion Criteria:

* relapse of Multiple Sclerosis or Clinically Isolated Syndrome (without complete remission after high dose steroid therapy)
* informed consent
* age ≥ 12 years old

Exclusion Criteria:

* clinical or laboratory signs of infection
* intake of Angiotensin Converting Enzyme Inhibitor within 1 week prior to first treatment
The Effect of Pre-washing the Insemination Catheter on Pregnancy Outcome

The investigators hypothesize that washing the insemination catheter prior to performing the IUI (intrauterine insemination) will improve the pregnancy outcome in IUI cycles when compared to controls (without pre-washing the catheter).

Catheter washing is performed routinely before embryo transfer, however it is not done for IUI catheters. Therefore no data is available on applying the technique to IUI catheters prior to insemination.

OBJECTIVES:

Primary objective:

To determine if pre-washing the catheter before insemination improves the pregnancy outcome in women undergoing IUI.

Secondary objectives:

1. To evaluate the impact of pre-washing the catheter before insemination on the ectopic pregnancy rate in women undergoing IUI.
2. To evaluate the impact of pre-washing the catheter before insemination on the miscarriage rate in women undergoing IUI.
3. To evaluate the impact of pre-washing the catheter before insemination on the multiple pregnancy rates in women undergoing IUI.

STUDY DESIGN:

The study will be a prospective double blind trial among women undergoing IUI at the MUHC reproductive centre using a cluster randomized design. The week will be defined as the unit for the clusters of randomization. Weeks will be allocated to one of the following groups:

* Group 1 = pre-washing group (patients will have the IUI with a pre-washed catheter during that week)
* Group 2 = control group (no pre-washing before IUI during that week)

A random block size will be used to minimize the risk of non-blinding. The study is double-blind, neither the patients nor the physicians performing IUI will know whether the catheter was washed or not, as both the sample and the catheter will be prepared by the andrology lab technician. The cluster randomization design is justified since the management of the unit will not allow us to perform a randomization at the patient level.

However a very low Intra-Correlation Coefficient (ICC) between patients is expected.

Eligibility Criteria:
Inclusion Criteria:

* Infertile women age ranges from 18 to 40 years at the time of treatment at the MUHC reproductive centre.
* Patients undergoing IUI.
* Fresh and frozen sperm treatment cycles
* Hormone induced and natural cycle (no hormonal stimulation).
* Patients speaking English or/and French.
* Patients able to consent.

Exclusion Criteria:

* Patients younger than 18 years or older than 40 years of age.
* Patients undergoing ovarian stimulation without IUI.
* Patients who have been recruited in our study in a previous IUI cycle.
* Patients who don't speak English or French.
* Patients who are not able or refuse to consent.
* Patient who are recruited in a different IUI research study.
Primary Care Management of Community-Acquired, Methicillin-Resistant Staphylococcus Aureus (CA-MRSA) Infections

The goal of this study is to further the investigators' understanding of community acquired methicillin-resistant Staph Aureus (CA-MRSA) and treatment of it by developing real-world sustainable strategies consistent with existing guidelines on treatment of CA-MRSA from the Centers for Disease Control and Prevention (CDC) and test these strategies in busy primary care settings.


Eligibility Criteria:
Inclusion Criteria:

* All patients presenting at a primary care clinic who have a skin or soft tissue infection.

Exclusion Criteria:

* None
Universal Screening Program for Cytomegalovirus Infection in the First Trimester of Pregnancy (CITEMB Study)

The aim of this study is to evaluate a universal cCMV screening programme in the first trimester of pregnancy in primary care in Catalonia (Spain).

This is the pilot study of implementation of the CMV universal screening program in the first trimester of pregnancy Barcelona and its metropolitan area.

General objective The aim of this study is to evaluate a universal CMV screening programme in the first trimester of pregnancy in primary care.

Specific aims of this pilot study:

1. Estimate the percentage of acceptance of CMV screening in the population
2. To observe and to determine the rate of CMV primary infection in the first trimester of pregnancy
3. To identify and describe the rate of the vertical fetal infection detected through the amniocentesis of the 2nd trimester
4. To identify and describe the rate of fetal sequelae (due to the primary CMV infection in the first trimester), obtained by imaging techniques (ultrasound and MRI)
5. To identify and describe the rate of neonatal infection (congenital CMV)
6. To identify and describe the rate of sequelae for congenital CMV at one year of the child's age
7. To identify and describe the percentage rate of TOP following the diagnosis of primary infection on CMV
8. To identify and describe the rate of legal of TOP following the diagnosis of fetal infection
9. To identify and describe the rate of TOP following the diagnosis of fetal anomalies
10. To obtain and describe the annual cost of CMV screening in the first quarter in Catalonia (Spain).

Eligibility Criteria:
Inclusion Criteria:

* maternal age 16 years or older, and
* gestational age less than 14 weeks.

Exclusion Criteria:

* language barrier preventing informed consent,
* gestational age at blood sampling above 14 weeks, and
* consent withdrawal
Transperineal Versus Transrectal Prostate Biopsy

Background: Prostate biopsies are essential to diagnose prostate cancer (PCa). Transrectal prostate biopsies (TR-PB) are commonly performed, however disadvantages include the requirement of antibiotic prophylaxis (AP) and higher complication rates than transperineal prostate biopsies (TP-PB). Guidelines still recommend the use of AP for TP-PB due to the limited evidence regarding complication rates after their omission. However, the rising rates of antibiotic resistance is of concern. The aim of this study was to compare the complication and detection rates of freehand TP-PB without AP versus TR-PB with AP.

Methods: This single center retrospective study was performed in an academic hospital. TP-PB were introduced in 2019 and implemented as the main technique by late 2020. To compare the two techniques, data was collected for freehand TR-PB with AP between 2017-2018 and freehand TP-PB without AP between 2021-2022. The data from 2019 and 2020 were excluded to rule out the effects of the initial learning curve during the transition period. Primary outcome measure was post-biopsy complications occurring within 2 weeks, focusing on infectious complications. Secondary outcome measures were detection rates and upgrading/reclassification in the repeat biopsy in active surveillance (AS). Statistical analysis was performed using a Fisher exact or Chi-Squared test.


Eligibility Criteria:
Inclusion Criteria:

* men who underwent prostate biopsy between 2017-2018 (transrectal)
* men who underwent prostate biopsy between 2012-2022 (transperineal)

Exclusion Criteria:

* positive urine culture before biopsy
* patients in the transrectal biopsy group who did not take the prescribed course of antibiotic prophylaxis
* incomplete medical dossier where the occurrence of a complication could not be assessed
Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification

Dipeptidyl peptidase-4 (DPP-4) inhibitors improve glycemic control and contain pleiotropic actions on kidney injury, albuminuria and vascular inflammation especially in animal models. We plan to evaluate the efficacy of potent DPP4-inhibitors (gemigliptin) in response to these aspects in diabetic nephropathy patients.

This is a multi-center, prospective, randomized, placebo-controlled trial. A total of 201 participants were enrolled and randomly assigned to gemigliptin 50 mg daily and standard care of diabetes mellitus for 6 months. The changes of coronary calcium score (CAC score), cardio-ankle vascular index (CAVI), estimated glomerular filtration rate (GFR), markers of vascular calcification and markers of tubular renal injury were evaluated at baseline and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CKD stage 1-3 (eGFR 15-60 ml/min/1.73mL)
* Non-insulin dependent diabetes mellitus , blood glucose level 30-250 mg/dL
* Had clinical features compatible with diabetic nephropathy (urine micro albuminuria \> 30 g/g creatinine or has evidence of diabetic retinopathy

Exclusion Criteria:

* History of allergy to DPP4-inhibitor
* Concurrent infectious disease
* Inflammatory diseases
* Post kidney transplantation
* Receiving cinacalcet, bisphosphonate ,previously treated with DPP4-Inhibitors and sodium-glucose cotransporter-2 inhibitor (SGLT2-i).
Immune Correlates of Cardiac Structure and Function

The purpose of this study is to determine the occurrence of scarring of the heart (cardiac fibrosis) and inflammation in those with perinatally acquired Human Immunodeficiency Virus (HIV) infection compared to people not infected with HIV. The information learned from this research may help the investigator to better understand the link between cardiac fibrosis and cardiac dysfunction and inflammation in those with perinatally acquired HIV infection compared to the uninfected.

Participants will have a blood sample, complete a patient questionnaire, and have a Magnetic resonance imaging (MRI) and ultrasound of the heart.

Researchers will review the medical record and past medical history, for information about your heart function and overall health. Research samples and data from this study will be stored indefinitely and used for other research.

There are risks to participate in this study and those risks include side effects from the contrast agent used for the MRI scan, (such as headache and injection site pain), and risks from blood sampling.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals 20-45 years of age
2. Willingness and ability to provide signed and dated written informed consent, prior to any study-related procedures
3. Diagnosed with HIV \<10 years of age or physician confirmation of perinatal HIV infection
4. On antiretroviral treatment (ART) for at least the last greater than or equal to 6 months
5. Willingness to undergo Cardiovascular magnetic resonance imaging (CMR)
6. Willingness to undergo echocardiogram (ECHO) (may be included if ECHO has been done at Duke in the previous 24 months).
7. Willingness to have research blood draw

Exclusion Criteria:

1. Contraindication to CMR (metal fragments in eyes or face, implanted electronic devices such as pacemakers, defibrillators, cochlear implants, or nerve stimulators, aneurysm clips)
2. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2
3. History of anaphylactic reaction to gadolinium contrast
4. Inability to complete an MRI scan in the past due to anxiety
5. Recent acute medical illness resulting in recent hospitalization (in past 90 days)
6. History of: Coronary artery disease (CAD), Myocardial infarction (MI), moderate-severe valvular disease, congenital heart disease, heart failure, non-ischemic CM, Atrial fibrillation/flutter, implantable cardioverter defibrillator (ICD)/pacemaker, myocarditis prior
7. Current Symptoms of Shortness of breath, severe chest pain, palpations, difficulty breathing on exertion, swelling of legs
8. Known to be pregnant or current breastfeeding
9. Known to be on hemodialysis
10. Inability to breath hold for 5-10 seconds
11. Known to have an ejection fraction \<45% in the past 24 months
12. Active cancer or cancer chemotherapy or radiation treatment in the prior year.
13. Comorbid inflammatory disease, specifically treated for rheumatoid arthritis (RA) or lupus (SLE)
14. Chronic use of steroids or anti-inflammatory therapy
Prevention of Energy Deficit Syndrome in Female Athletes. Molecular Mechanisms Associated With Malnutrition.

Energy Deficit Syndrome (RED-S) is the impairment of physiological functioning caused by relative energy deficiency and includes impaired metabolic rate, menstrual, endocrine, hematological, immunological, gastrointestinal, bone, psychological, developmental and cardiovascular function. Eighty-seven percent of athletes show at least one symptom related to RED-S, with a higher prevalence in women. Treatment of RED-S preferably involves a multidisciplinary team of health professionals to address the complex interaction of nutrition, training, body image and performance. The main objective is to prevent energy deficit syndrome in female athletes in the province of Alicante through different training and diet protocols using a virtual platform. A 12-week single-blind randomized clinical trial with an intervention period and a control period (RCT) is proposed. The sports federations of the most representative practices in the province of Alicante will be selected by randomized sampling. The female athletes will be randomly divided into 4 groups (control group; control group with free use of the virtual platform; intervention group with Mediterranean diet and physical exercise planning; intervention group with red fruits and physical exercise planning).


Eligibility Criteria:
Inclusion Criteria:

* (a) exercise at least 3 days/week,
* (b) not having any diagnosed chronic pathology or ailment that prevents physical exercise or following nutritional guidelines rich in antioxidants.

Exclusion Criteria:

- All individuals taking medication that could affect the results of the study will be excluded from the study.