cyrilzakka/clinical-trials huggingface dataset:
Acupressure Mat on Perceived Stress, Sleep Quality and Premenstrual Symptoms

Purpose of the study: To examine the effect of acupressure mat on perceived stress, sleep quality and premenstrual symptoms in students with premenstrual syndrome.

Hypotheses of the study;

In the post-test and follow-up test between students who were applied acupressure mat and those who were applied plain mat;

H10: There is no difference in terms of severity of premenstrual symptoms.

H20: There is no difference in terms of perceived stress.

H30: There is no difference in terms of sleep quality.


Eligibility Criteria:
Inclusion Criteria:

* Using medication and/or non-medical methods to cope with PMS
* Having any gynecological disease (abnormal uterine bleeding, myoma, ovarian cyst, etc.)
* Using contraceptive medication.

Exclusion Criteria:

* Participants wanting to withdraw from the study at any stage of the study
* Participants not complying with the research plan
* Diagnosed with a psychiatric or gynecological disease during the study
* Participants starting to receive additional treatment for PMS during the study period
A Contribution to the Analysis of the Phenotypic Heterogeneity in Crack/Cocaine Addiction : a Case Control Study

The purpose of this study is to assess the phenotypic candidates symptoms, in patients with crack/cocaine addiction, in terms of clinical comorbidities, dimensions of personality, and neuropsychological evaluations apt to be associated with genetic and genotypic characterisations, notably on the polymorphisms of the genes coding or regulating dopaminergic, norepinephrine and serotoninergic systems.

Genetic studies show an association between drug addiction and the dopaminergic system and its modulators. Nonetheless, results are contradictory, partially due to the heterogeneity of the phenotype addiction. Placed on the trafficking route of cocaine, and homogeneously populated, Martinique is of particular interest for the study of the vulnerability of the crack/cocaine addiction. In a precedent study, supported by a grant MILDT / INSERM 2000, on 155 men dependent to crack/cocaine and characterised with three clinical dimensions -sensation seeking, impulsivity and childhood ADHD- we found an association between each dimension and polymorphisms of DRD2 and DRD4 genes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cocaine abuse/dependence according to DSM-IV-TR criteria
* Come from French West Indies (3 grandparents are African-Caribbean)
* Sign a written informed consent

Exclusion Criteria:

* Minor
* Men with no cocaine abuse/dependence according to DSM-IV-TR criteria

For the control:

Inclusion Criteria:

* Platelets donor
* No substance abuse/dependence according to DSM-IV-TR criteria
* Come from French West Indies (3 grandparents are African-Caribbean)
* Sign a written informed consent

Exclusion Criteria:

* Minor
* Men refusing a genetic study
Learning-curve-based Simulation Training for Bronchoscopic Intubation

This study aims to determine whether a new learning-curve-based simulation training modality could contribute to a noninferiority regarding bronchoscopic-guided intubation time in patients compared with the reference fixed-training-time simulation training modality, albeit with less training time.

Questions remain concerning the optimal duration of simulator training for flexible optical bronchoscopic (FOB) intubation. The investigators' previous study demonstrated that an exponential curve could fit the learning curve of FOB intubation training on a high-fidelity simulator after logarithmical transformation of the procedure time. In brief, trainees could achieve a plateau of the learning curve after several procedures, i.e., further training might provide only negligible progress. According to the investigators' preliminary study, the training time for the majority might be less than one hour which is the dominant duration of simulator training in previous studies. By generating a learning curve from the initial several procedures on a simulator, it is possible to predict when a trainee could grow saturated individually. It is hypothesized that this new learning-curve-based training modality could contribute to non-inferior FOB intubation time in patients compared with the reference fixed-training-time (1 hour) training modality, albeit with less training time. The noninferiority margin is defined according to the reported FOB intubation time and the training effect in previous studies. Moreover, it is plausible that this new training modality might even present a higher success rate and better performance of FOB intubation, considering each trainee following the new training has to achieve the individual goal that precludes an outlier from failing to have enough training that might occur in reference fixed-training-time training.

Eligibility Criteria:
Inclusion Criteria:

1. anesthesia residents or interns at Peking University People's Hospital, Beijing, China or Tibet Autonomous Region People's Hospital, Lhasa, Tibet, China;
2. have performed less than five FOB intubations in patients;
3. consent to this study. -

Exclusion Criteria:

Those who have received standardized training will be excluded.

-
The Galway Sea Swimmers Study

Cardiovascular disease (CVD) is the leading cause of death worldwide. Hypertension is a well-established risk factor for the development of CVD. Lifestyle modifications, including exercise, remain the cornerstone of blood pressure (BP)-lowering strategy. Swimming has long been a popular recreational activity for exercise, and is recently gaining widespread recognition as an effective option in maintaining and improving cardiovascular health. Previous studies that involved pool swimming as an intervention (versus no pool swimming) demonstrated favorable benefits of the former on BP reduction. However, no studies to date have specifically investigated the effect of cold-water sea swimming on BP. Indeed, the naturally lower water temperature in the sea may engender a 'cold water immersion' experience in sea swimmers with subsequent stress physiology, which have been shown to exert unique effects on cardiovascular hemodynamics. This study primarily aims to determine the impact of cold-water sea swimming on BP in a group of habitual sea swimmers in Galway who will be randomly assigned to either continue or stop swimming for 4-6 weeks. Other objective and subjective health benefits to sea swimming will also be explored in this study. Given the ubiquitous nature of this activity in the Irish general public, particularly in Galway, this study has potential from a public health perspective, and would add to the literature base pertaining to the benefits of sea swimming on cardiovascular health.

Consenting participants will be randomly assigned, 1:1, to either continuation of sea swimming or discontinuation of sea swimming for 4-6 weeks, stratified by the type of swimmer (those who purely immerse in the water for a brief period of time versus those who actually swim \[i.e., exercise\] in the water) and use of blood pressure medication at the time of study commencement (yes or no), using a block size of four to maintain balance between intervention arms. In line with previous studies that assessed the impact of swimming intervention on BP, participants randomized to the swimming arm should pursue sea swimming 2 or more days/week.

Eligibility Criteria:
Inclusion Criteria:

* habitual swimmers (i.e., sea swimming at least 2 times/week for the past year)
* 18 years of age or older
* able to provide informed consent

Exclusion Criteria:

* underlying cardiac (e.g., self-reported heart failure) or pulmonary diseases (e.g., self-reported chronic obstructive pulmonary disease)
* recent orthopedic procedures (e.g., joint replacement therapy)
* severe disabling comorbidity
* recent arm (both arms) or chest wall injury
* pregnant or breast feeding
A Multicenter Prospective Clinical Cohort Study on the Pathogen Spectrum of Severe Hepatitis (Liver Failure) Complicated With Infection

The goal of this observational study is to expound the population and characteristics of pathogenic microorganisms with co-infection, draw the pedigree of pathogenic microorganisms, and evaluate its influence on disease outcome in patients with severe hepatitis (liver failure). The main questions it aims to answer are:

* Mapping of infectious agents in patients with severe hepatitis (liver failure)
* Constructing early warning predictive models to explore how to give an individualized regimen of integrated immune function.

Liver failure is a clinical syndrome caused by a large number of necrotic hepatocytes leading to severe liver function damage, with jaundice, coagulation dysfunction and hepatic encephalopathy as the main manifestations, which can be caused by a variety of reasons, and the liver failure caused by Hepatitis B Virus (HBV) is the first one in our country, which accounts for about 80% of the cases. Through the "Eleventh Five-Year Plan" to "Thirteenth Five-Year Plan" national scientific and technological major special projects, the death rate of patients with early and middle stage of severe hepatitis B has been significantly reduced, but the death rate of patients with advanced stage is still as high as about 60%, especially when liver failure is combined with other complications, such as This study focuses on the impact of secondary infections on the clinical prognosis of severe hepatitis (liver failure), and intends to establish a prospective, multi-center clinical cohort of secondary infections in liver failure, map the infectious pathogens, correlate the basic immune status with the characteristics of the pathogen profile of the secondary infections, and establish a monitoring and early-warning system of secondary infections, so as to explore safe and effective treatment modalities. To further reduce the mortality rate of liver failure.

Eligibility Criteria:
Inclusion Criteria:

1. Patients agreed to participate in the study and signed an informed consent form;
2. Sex is not limited and age is 18-70 years old;
3. HBsAg positive for more than 6 months, or hepatitis E IgM positive, or hepatitis E RNA positive;
4. Progressive deepening of jaundice in a short period of time (serum total bilirubin greater than 10 times the upper limit of normal or rising ≥17.1 umol/L per day);
5. Sgnificant bleeding tendency with PTA ≤ 40% and exclusion of other non-hepatic factors.

Exclusion Criteria:

1. Patients with severe hepatitis caused by other non-hepatophilic viral infections;
2. Patients who were considered by the investigator to be unsuitable for participation in the study.
Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Colorectal Cancer

The purpose of this study is to evaluate the safety and time to progression of HLA-A\*2402 restricted epitope peptides RNF43, TOMM34, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with Tegafur/Uracil/Folinate chemotherapy.

RNF43 and TOMM34 have been identified as cancer specific molecules especially in colorectal cancer using genome-wide expression profile analysis by cDNA microarray technique. VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, RNF43 peptide (1mg), TOMM34 peptide (1mg), VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. The patients will also receive oral chemotherapy (Tegafur/Uracil/Folinate) simultaneously. Repeated cycles of the vaccine and the chemotherapy will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of these peptide vaccine. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.

Eligibility Criteria:
Inclusion Criteria:

* Advanced or recurrent colorectal cancer
* Resistant against chemotherapy including CPT-11, l-OHP、+/- 5-FU +/- bevacizumab or difficult to continue the chemotherapy due to intolerable side effect(s)
* ECOG performance status 0-2
* Life expectancy \> 3 months
* HLA-A\*2402
* Laboratory values as follows

  * 2000/mm3\<WBC\<15000/mm3
  * Platelet count\>100000/mm3
  * Bilirubin \< 3.0mg/dl
  * Asparate transaminase \< 150IU/L
  * Alanine transaminase \< 150IU/L
  * Creatinine \< 3.0mg/dl
* Able to receive oral Tegafur/Uracil/Folinate therapy
* Able and willing to give valid written informed consent

Exclusion Criteria:

* Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)
* Breastfeeding
* Active or uncontrolled infection
* Unhealed external wound
* Concurrent treatment with steroids or immunosuppressing agent
* Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
* Uncontrolled brain and/or intraspinal lesion(s)
* History of allergy to Tegafur, Uracil, and/or Folinate
* Decision of unsuitableness by principal investigator or physician-in-charge
SpeeDx Ciprofloxacin gyrA Assay for N. Gonorrhoeae Gonococcal Infection

This study aims to test the effectiveness of using of SpeeDx Resistance Plus assay to guide treatment of Neisseria gonorrhoeae (Ng) in a sexual health clinic setting.

Patients entering the Sexual Health Clinic will be offered participation in the study if they have; 1) no infectious genitourinary symptoms that require immediate treatment, 2) who seek routine STI screening, 3) if they report sexual contact with a partner who reports having Ng or 4) men who have sex with men (MSM) with contact to chlamydia trachomatis (CT).

All participants will have specimen collected from anatomical sites of exposure for NAAT and culture. NAAT specimen positive for Ng will be flagged and further tested with SpeeDx Resistance Plus assay. This will delay results reporting on average by 1 day. The assay detects Ciprofloxacin resistance based on a point mutation of the gyrA gene (gyrA s91). Participants without this mutation or wild-type (gyrA WT) infection should be sensitive to Ciprofloxacin.

Participants who are N. gonorrhoeae (NG) positive and gyrA WT, will receive ciprofloxacin 500 mg PO x 1.

Participants with gyrA s91 mutation will be asked to return to clinic for the standard of care (i.e. ceftriaxone-based therapy).

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Have access to the internet (via computer or phone) on at least a weekly basis
* Asymptomatic (as defined below)

Exclusion Criteria:

* Urogenital symptoms consistent with a sexual transmitted infection (other than vaginitis associated with trichomonas vaginalis, bacterial vaginosis or yeast). Symptoms consistent with cervicitis, urethritis, or PID will not be offered enrollment.
* Antibiotic use within the last 2 weeks
* Contact to syphilis
* Contact to an STI and are unwilling to defer empiric treatment until diagnostic test results return
* Anyone receiving a gonococcal-active drug (such as Doxycycline, Penicillin, Ceftriaxone) during the visit. Those receiving metronidazole, fluconazole, or clotrimazole will not be excluded.
* Known allergy to ciprofloxacin and/or ceftriaxone
Influence of DHA-rich Supplement on DHA-status and Health Evolution of Patients With Cystic Fibrosis

Investigation of the influence of giving DHA-rich supplement versus placebo on DHA-status and health evolution of patients with cystic fibrosis

Investigation of the influence of giving DHA-rich supplement versus placebo on DHA-status and health evolution of patients with cystic fibrosis

Eligibility Criteria:
Inclusion Criteria:

* Delta F 508 homozygote
* Stable clinical situation

Exclusion Criteria:

-
Study of Disitamab Vedotin Combined With Gemcitabine in Neoadjuvant Treatment of Urothelial Carcinoma

A multicenter, open, single arm, phase II clinical trial was designed for myometrial invasive bladder cancer to evaluate the efficacy and safety of RC48-ADC combined with gemcitabine in preoperative neoadjuvant treatment of MIBC, and provide high-level clinical evidence for gemcitabine combined with ADC in the treatment of MIBC

Patients with myometrial invasive bladder cancer expressing HER2 and not suitable for cisplatin chemotherapy were treated with vedixizumab (RC48) 2.0mg/kg, once every two weeks, intravenous drip (60-90min); Gemcitabine is 1000mg/m2, once every two weeks. After completing 3 cycles of neoadjuvant combined therapy, imaging evaluation was performed. If the tumor is T0, radical surgery for bladder cancer was performed; Otherwise, perform radical surgery for bladder cancer (total cystectomy+standard/extended lymph node dissection) after completing 1-3 cycles of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects voluntarily joined the study, signed the informed consent form, and were able to follow the study and follow-up procedures
2. Age 18-75
3. Suitable and planned for radical cystectomy (including lymph node dissection)
4. Clinical stage T2-T4aN0M0 (CT/MR/PET-CT evaluation)
5. Pathologically, it is urothelial carcinoma, and the patient has HER2 expression and refuses neoadjuvant chemotherapy or physical condition/renal function \[glomerular filtration rate (GFR) 30-60mL/min\], which is not suitable for neoadjuvant chemotherapy (pathology allows urothelial carcinoma to merge with other variant subtypes, with urothelial carcinoma as the main type)
6. ECOG score 0 or 1
7. There is residual tumor after TURBT (cystoscopy or imaging evidence)
8. The blood test of subjects should meet the following requirements

Exclusion Criteria:

1. Receive live attenuated vaccine within 4 weeks before enrollment or during the study period.
2. Have received systemic chemotherapy and targeted therapy of anti-PD-1, PD-L1 and HER2 in the past 6 months
3. Known allergy to gemcitabine/RC48 and its components
4. Active, known or suspected autoimmune diseases.
5. A history of primary immunodeficiency is known.
A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 with Valganciclovir (VGCV) in Subjects with Glioblastoma

This is a Phase 1/2a, open-label study to evaluate the safety, tolerability, immunogenicity, and preliminary clinical activity of RZ-001 administered in combination with VGCV in subjects with hTERT-positive GBM.

The study consists of 2 parts: a dose-escalation part (Part 1) and a dose-expansion part (Part 2).

Part 1 consists of dose escalation exploring MTD/RP2D for intratumoral (IT) injection.

Part 2 will consist of dose expansion exploring clinical activity for the optimal fixed dose based on the results of Part 1.

Eligibility Criteria:
Inclusion Criteria:

* Adult males and females
* Histologically-confirmed grade 4 astrocytoma, GBM, per The 2021 WHO Classification of CNS Tumors.
* hTERT positive expression confirmed during the screening period
* ECOG score of ≤ 2
* KPS ≥ 60
* Life expectancy ≥ 3 months

Exclusion Criteria:

* Diagnosis of other malignant tumors within 5 years prior to RZ-001 administration.
* Have extracranial metastases of the tumor cells
* Current or history of HIV positive
* Not suitable for inclusion judged by the investigator
Portal Venous Hemodynamic Changes After Hepatectomy

The aim of this study is to investigate the pathophysiological mechanisms underlying the formation of posthepatectomy ascites with a focus on the significance of changes in portal venous hemodynamics after hepatic resection. By evaluation of other factors that may be involved in the formation of ascites this study may help to show to what extent the increase of portal venous pressure contributes to ascites formation. Detailed knowledge about pathogenetic factors concerning the formation of postoperative ascites might help preventing protracted hospital stay and further inconveniences to the patient.

The mechanisms underlying the development of large-volume ascites after hepatectomy remain poorly understood. While studies on animal models suggest an increase of portal venous pressure after hepatectomy that may in turn favor the transudation of fluid into the peritoneal cavity further factors may be critically involved in the postoperative formation of ascites. These factors may include a drop in serum protein levels (and colloid osmotic pressure), a transient impairment in renal function and a surgery-induced capillary leakage. However, a better knowledge of the pathophysiology represents the prerequisite for efficient treatment.

In the present study the impact of changes in hepatic hemodynamics after hepatectomy on development of ascites will be investigated. Enrolled patients will receive measurement of portal venous flow and pressure as well as hepatic artery flow before and after hepatic resection. Associations of changes in these parameters with development of postoperative ascites and further postoperative complications will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective hepatic resection
* Age equal or greater than 18 years
* Informed consent

Exclusion Criteria:

* Evidence of ascites or hypalbuminemia preoperatively
* Renal insufficiency
* Expected lack of compliance
* Impaired mental state or language problems
A Single Center Clinical Evaluation of Same Sitting Hybrid Revascularization: Robotic Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention for the Treatment of Coronary Artery Disease

The primary objective of this study is to assess the safety and effectiveness of same sitting, simultaneous hybrid robotic assisted coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) in the treatment of obstructive multivessel coronary artery disease. A secondary objective is the assessment and standardization of optimal operator techniques and comparative study of patients undergoing CABG during study period.

The study population will consist of patients with multivessel coronary artery disease requiring CABG with suitable anatomy for combination CABG and PCI of non-bypassed arteries.

The primary endpoint of this feasibility study is a 30-day composite of major adverse clinical events including death, repeat revascularization, stroke and/or myocardial infarction.

The secondary endpoints include:

1. Successful completion of same sitting CABG and coronary stent procedure
2. Successful completion of CABG and PCI during single hospitalization
3. Achievement of complete revascularization
4. Patency of the LIMA and stented vessels as determined by coronary angiography at time of procedures or prior to discharge and by cardiac Computed Tomographic Angiography (CTA) or coronary angiography at 1 year.
5. Stent thrombosis at 24 hours (acute), 30 days (sub acute), and 1 year (late)
6. One-year composite clinical event endpoints of major clinical events including death, repeat revascularization, myocardial infarction, and freedom from angina
7. Comparative analysis of hospital, 30 day, and 1 year events of hybrid CABG patients compared to consecutive patients undergoing off pump CABG with standard thoracotomy during study period

Eligibility Criteria:
Inclusion Criteria:

* Requirement for CABG
* Anatomy and body habitus suitable for Robotic CABG
* Requirement of revascularization of arteries amendable for PCI but not accessable by Robotic CABG

Exclusion Criteria:

* Need for emergent CABG