cyrilzakka/clinical-trials huggingface dataset:
Comparison of Topical and Intravenous Tranexamic Acid in Total Hip Arthroplasty

Recently, there has been interest in applying tranexamic acid topically before the closure of surgical wounds in total hip replacement. It has the advantages of ease of application, maximum concentration at the site of bleeding, minimising its systematic absorption and, potentially , decline the risks for systematic side-effects 。

Objectives:To assess the efficacy and safety between the two different applying routes.

Patients in this project are randomly divided into three groups , one group is a blank group and the rest two groups receive either the topical or the intravenous form of tranexamic acid during unilateral THA(total hip arthroplasty).The total blood loss(TBL) will be calculated as the primary outcome for efficacy while the events of Deep Vein Thrombosis、Pulmonary Embolism、Acute Myocardial Infarction 、 Acute Kidney Infarction and Cerebral Infarction will be recorded to assess the safety of the tranexamic acid during a six-week follow-up for each patient.

All surgery are under general anesthesia, through direct lateral approach with cementless prosthesis. For all patients, the drain tube is clamped and closed completely for 2 hours; then the clamp is fully opened.

Eligibility Criteria:
Inclusion Criteria:

1. Consented to join in our project.
2. Adult patients (greater than 18 years old)
3. Patients scheduled for primary unilateral hip arthroplasty Patients for Ruijin hospital, Shanghai, China

Exclusion Criteria:

1. Patients who refuse to sign the Inform Consent
2. Had an allergy to TXA.
3. long-term bed \>=3 weeks.
4. Using anticoagulant drugs within a week.
5. Coagulopathy (preoperative platelet count \<150,000/mm3, INR\>1.4, prolonged Activated Partial Thromboplastin Time，Prothrombin Time ，or thrombin time (\>1.4 times longer than normal)
6. Pregnancy
7. Breastfeeding
8. Major comorbidities: Severe ischemic heart disease(class III and IV of New York Heart Association); sleep apnea syndrome; renal dysfunction ( glomerular filtration rate\<60); or hepatic disfunction(glutamic-pyruvic transaminase\>80 or glutamic oxalacetic transaminase\>80).Retinopathy (disturbances of color vision).
9. History of thromboembolic disease: .
10. Been participating or been participated within a year in another clinical trial
Individual Responder Analysis of the Effectiveness of Manual Therapy and Exercise Versus Usual Care in Patients With Chronic Nonspecific Neck Pain

The aim of this study is to compare the effectiveness of a combined intervention of manual therapy and exercise versus usual care, on pain intensity, disability, and global perceived recovery, in patients with chronic nonspecific neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Chronic nonspecific neck pain at least 3 months, defined as pain in the cervical region without a specific anatomopathological diagnosis;
* Adults between 18 and 65 years of age and literate in Portuguese;

Exclusion Criteria:

* History of cervical trauma and/or history of surgery in the prior 6 months;
* Clinical signs of infection, tumor, neurological, inflammatory or systemic diseases;
* Pregnancy
Robot-assisted vs Laparoscopic Radical Prostatectomy for Prostate Cancer Treatment

This study is to compare the outcomes of robotic-assisted laparoscopic radical prostatectomy (RARP) and laparoscopic radical prostatectomy (LRP) for prostate cancer treatment in terms of perioperative surgical, functional and oncological outcomes.

Participants will either have robotic-assisted laparoscopic radical prostatectomy (RARP) or laparoscopic radical prostatectomy (LRP) as determined by the treating surgeon. All participants will undergo tests and questionnaires to determine urinary and erectile function, biopsies to determine perioperative surgical, functional and oncological outcomes. These assessments will be conducted pre-operatively, post-operatively and at certain follow-up time points up to 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Adult men aged 18 years and over;
2. Undergoing RARP or LRP. prostatectomy for prostate cancer at Binh Dan Hospital;
3. Clinically suitable for radical prostatectomy (cT1-3, No, Mo);
4. Cognitively able to give written informed consent for participation;
5. Elective procedure.

Exclusion Criteria:

1. The patient lacks the ability to consent for themselves;
2. Patients unwilling to undergo pre- and post-operative evaluation according to the protocol;
Study of the Fixation of Various Vectors in PET/CT in Patients With a With Lung Cancer Before and During of CRT or RT

Study of the modification of the fixation(binding) of Fluoro-2-deoxy-D-glucose (FDG), fluoro-misonidazole (FMISO) and 3'deoxy-3-fluoro-thymidine deoxy-3-fluoro-thymidine (FLT) measured in tomography by broadcast(emission,issue) of positrons (PET) at patients before and in the course of exclusive radiotherapy or concomitant radiochemotherapy for primitive bronchial cancer.

This protocle allows to study the simultaneous variations of the metabolism, the hypoxie and the cellular proliferation by PET SCAN at 5 patients reached(affected) by a primitive bronchial cancer in the course of exclusive radiotherapy for primitive bronchial cancer not small cell lung.

The investigators are also going to study several scenarii of optimization of the radiotherapy according to the variations of the tumoral metabolism, the hypoxie and the cellular proliferation measured in the course of radiotherapy (theoretical study on console using the scanner and the various examinations).


Eligibility Criteria:
Inclusion Criteria:

* patients with non-small-cell lung carcinoma hitologicaly proved
* Candidate patients in a treatment with aim guardian by exclusive thoracic radiotherapy or of concomitant radiochemotherapy (tumoral dose superior to 60 Gy) ( n=5 ).
* Measurable tumor according to the criteria of evaluation RECIST

Exclusion Criteria:

* Histology other one than primitive bronchial cancer not in small cells lung
* The patients for whom no tumoral target is assessable (forgiveness completes after first chemotherapy, operated patients).
* Patients for whom a radiotherapy with curative aim is not indicated (tumoral extension, metastases, general state, co-morbidity).
* Patient having benefited from an examination PET in the FDG with in more than 4 weeks and for which a new PET in the FDG is not necessary with in the framework of its disease
Functional Evaluation of Two Infant Formula Supplemented With Probiotics Isolated From Breast Milk

A randomized double blinded controlled study including infants at the age of 1 month . Infants are assigned randomly to either infant formula supplemented with B. breve CECT7263 or L.fermentum CECT5716 (Probiotic groups), or the same formula without the probiotic strain (Control group). The primary outcome of the study is the body weight gain of infants. Secondary outcomes are incidence of infections, symptoms related with intestinal function, and fecal microbiota


Eligibility Criteria:
Inclusion Criteria:

* Newborn infants at term (37-42 weeks gestational age) healthy during the first month of life, for reasons unrelated to the study, abandon breastfeeding during the first month of life.
* Signature of informed parental or guardian consent.

Exclusion Criteria:

* Allergic to the protein in cow's milk.
* Lactose intolerant.
* Suffering from a serious metabolic disease.
* They have experienced or are experiencing some severe gastrointestinal disease.
* Receive some form of chronic medication or are receiving antibiotics at the time of capture.
* Low expectation of compliance with the study protocol.
* allergic to any group of antibiotics.
Mindfulness Based Smoking Cessation Among Cancer Survivors

This study will examine the effect of a mindfulness-based smoking cessation program among cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* Be 18 years and older
* Cancer survivors (based on the NCI definition - "a person is considered to be a survivor from the time of diagnosis until the end of life" National Cancer Institute Dictionary of Cancer Terms, 2014)
* Cancer patients currently in active treatment
* Have smoked ≥ 5 cigarettes/day in the past year
* Be interested in making a quit attempt in the next 30 days
* Own a smartphone (apple/android)
* Read/speak English
* Able to consent
* Have no plans to move in the next 3 months
* Are not pregnant or planning to be pregnant in the following 3 months

Exclusion Criteria:

* Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder)
* Have cognitive/mental health impairment that inhibits mindfulness treatment
* Are currently being treated for smoking cessation, alcoholism, or illicit drug use
* Are adults unable to consent
* Are individuals who are not yet adults
* Are pregnant women
* Are prisoners
Integrative Omics Analysis for Colorectal Cancer and Metastasis

The pathogenesis of Colorectal cancer (CRC) metastasis remains unclear.We collect clinical data from our center and use Integrative omics to analyze and predict candidate biomarkers of colorectal cancer and distant metastasis.

Colorectal cancer (CRC), one of the most common malignant cancer around the world, CRC patients with distant metastasis. However, the pathogenesis of metastasis remains unclear. Integrative omics have begun to enable personalized medicine at an extraordinarily detailed molecular level. All patients with colorectal cancer and metastasis in our center who meet the inclusion criteria and exclusion criteria will be enrolled. The specimen collected by surgery and clinical data will be collected . We use Integrative omics such as RNA-sequencing,ATAC-seq(Assay for Transposase-Accessible Chromatin using sequencing), CUT\&Tag（ Cleavage Under Targets and Tagmentation）to analyze and predict candidate biomarkers of colorectal cancer and distant metastasis. This study will contribute to understanding the molecular mechanism of CRC metastasis in depth and contribute to the discovery of new appropriate molecular diagnostic and therapeutic targets, and more accurately prognose long term outcome in patients with CRC.

Eligibility Criteria:
Inclusion Criteria:

* colorectal adenocarcinoma by biopsy。
* at least 1 metastasis lesion comfirmed by at least 1 kind of imaging examination (CT, MRI and PET-CT )

Exclusion Criteria:

* recent diagnosis with other malignancies
* can not tolerate the surgery
* history of serious mental illness
* pregnancy or lactating women
* the researchers believe the patients should not enrolled in
Leveraging Behavioral Science to Improve Medicine Optimization Conversations with Older Adults

Our online, survey-based experiment will include 2,400 adults who are 65-years and older (n=1,200 each from United States and Australia). Each participant will be asked to give their opinions on a hypothetical patient scenario that has been developed by our diverse team in partnership with our stakeholder organizations.This work is expected to significantly contribute to our understanding of how older adults make decisions about deprescribing medications.


Eligibility Criteria:
Inclusion Criteria:

* 65 years and older and resides in Australia or the United States
Accuracy of Continuous Glucose Monitors During the Perioperative Period in Youth With Type 1 Diabetes

This study is assessing the accuracy of continuous glucose monitors during surgical procedures requiring anesthesia.

This study is an observational study design that includes collection of continuous glucose data and venous blood glucose data (from either an IV or fingerstick) from a blood glucose meter. All subjects will be undergoing a surgical procedure that requires anesthesia. The primary outcome of this study is to evaluate the accuracy of the CGM glucose values in comparison to the reference glucometer glucose value during anesthesia. There is currently limited data on accuracy of CGMs during these events and therefore it is not know whether CGM glucose data is reliable to be used as the sole source of glucose monitoring during surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Participants will be 2 to 26 years of age at the time of enrollment.
2. Participants will have a diagnosis of type 1 diabetes on insulin therapy and requiring close glucose monitoring during the hospitalization and the perioperative period.
3. Participant currently wearing a continuous glucose monitor (for example: Dexcom G6 or G7; Freestyle Libre 2, 2 Plus, or 3; Medtronic Guardian 3 or 4; or future sensors as they become available) for home diabetes management and willing to share personal CGM data with the BDC clinical CGM account.

Exclusion Criteria:

1. Pregnancy.
2. Currently using hydroxyurea.
3. A condition that the investigator determines would prevent the patient from participation.
The Efficacy of Hemp-containing Cream Versus Placebo in the Treatment of Uremic Pruritus

Uremic pruritus is a significant burden on hemodialysis patients, affecting approximately 46% of individuals undergoing dialysis. Various mechanisms, including inadequate dialysis, increased uremic toxins, inflammatory cytokines, parathyroid hormone, phosphorus, dry skin, mast cell histamine secretion, and nerve stimulation through μ-opioid receptors and nociceptors, contribute to uremic pruritus. Current treatments include antihistamines, gabapentin, moisturizer creams, and capsaicin creams, with limited success, as only 10% of patients find relief. Cannabinoids were also mentioned in uremic pruritus treatment but are less commonly used and there are no randomised controlled trial. Cannabinoid binding to CB1 and CB2 receptors inhibits mast cell differentiation, aggregation, and histamine release, whereas cannabinoid binding to TRP-iron receptors reduces peripheral nerve activation. Thus, cannabinoid seem to effective in relieving pruritus via various mechanisms.

This study aims to assess the effectiveness of a hemp-containing cream in comparison to a placebo for treating uremic pruritus among hemodialysis patients.

Eligible participants is randomly assigned in a 1:1 ratio to receive either a hemp-containing cream or a placebo. then, they are assessed for the severity of itching symptoms using the WI-NRS and their itch-related quality of life using the Skindex-10 score at baseline, week 2, and week 4 of the study. Additionally, adverse effects are documented. Data is collected by the research assistant and recorded in computer with locking password and also was validated with second assistant.

We planned for a sample size of 60 participants to detect differences in itchinEligible participants is randomly assigned in a 1:1 ratio to receive either a hemp-containing cream or a placebo. then, they are assessed for the severity of itching symptoms using the WI-NRS and their itch-related quality of life using the Skindex-10 score at baseline, week 2, and week 4 of the study. Additionally, adverse effects are documented. Data is collected by the research assistant and recorded in computer with locking password and also is validated with second assistant.

For statistical analysis, continuous variables are compared using an unpaired t-test or Mann-Whitney U test, as appropriate. Categorical variables are compared using a Chi-square test or Fisher's exact test. The adjusted mean difference is used Analysis of Covariance (ANCOVA) , adjusted by score at baseline.

All statistical analyses were performed using Stata v.17.0 (StataCorp, Texas).

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years old, diagnosed with end-stage kidney disease
* Undergoing thrice-weekly chronic hemodialysis for more than 90 days
* Exhibit a WI-NRS score of 3 or higher

Exclusion Criteria:

* Ahistory of hemp allergy
* Pregnancy or breastfeeding
* Dermatologic diseases
* Adjustments to medications for controlling itch within the 14 days preceding the study.
Remifentanil for Sedation of Patients With Traumatic Brain Injury (TBI)

This is a descriptive retrospective study designed to measure the efficacy of remifentanil sedation and the ability to perform frequent neurological examinations of patients with traumatic brain injuries.


Eligibility Criteria:
Inclusion Criteria:

* Patients previously admitted to the hospital presenting with traumatic brain injury (TBI)
* Patients who have undergone sedation after presenting with TBI

Exclusion Criteria:

* None
Group Motivational Intervention in Overweight/Obese Patients

Overall mortality, such as that caused by cardiovascular disease, increases as weight increases. In the Framingham Study, it was shown that obesity is a cardiovascular risk factor independent of other risk factors such as type 2 diabetes mellitus, dyslipidemia and smoking.

Objectives:

1. To determine whether a group motivational intervention is more effective than the standard intervention for treatment of overweight and obesity and most importantly to maintain the attained weight loss on a permanent basis.
2. To assess whether this intervention is more effective than reducing cardiovascular risk factors (lipid profile, apo B-100, apo A-1, fibrinogen, C-reactive protein, hypertension, diabetes mellitus) associated with overweight and obesity, and the overall cardiovascular risk in these patients.

Design: Randomized, multicenter, interventional clinical trial in patients with overweight and obesity. Randomized assignment of the intervention by Basic Health Areas (BHAs). Two groups will be established in geographically separate areas, one of which will receive the group motivational intervention (intervention group) and the other will receive standard follow-up (control group). BHAs located in the same building will be assigned the same group (control or intervention) to avoid potential contamination. hypertensive treatment or with a diagnosis of hypertension in their clinical history.

Study Scope: Primary care. The study will be conducted in 24 BHAs of Hospitalet de Llobregat and Barcelona during 26months follow-up period. Haematic analyses will be in the carried out at the reference laboratory.


Eligibility Criteria:
Inclusion Criteria:

* Overweight (BMI\>25) and obese (BMI\>30) patients of both sexes, registered in the medical history (MH) or newly diagnosed.
* Aged between 30 and 70 years
* Agreement to participate in the study

Exclusion Criteria:

* Patients with severe clinical pathology (bedridden, dementia, advanced neoplasia, etc.)
* Patients with secondary obesity (hypothyroidism, Cushing's disease, etc).
* Patients with severe sensorial disorders capable of interfering with the motivational intervention
* Patients with serious psychiatric disorders
Study of Targeted Therapy Using Transcription Activator-like Effector Nucleases in Cervical Precancerous Lesions

This is an single arm clinical study of the safety and efficacy of T512 to possibly treat cervical intraepithelial neoplasia(CIN).

Persistent infection with high-risk human papillomavirus (HPVs),especially types 16 and 18,may lead to cervical intraepithelial neoplasia(CIN).HPVs expresses the oncoproteins E6 and E7, both of which play key roles in maintaining viral infection and promoting carcinogenesis. Previous studies showed that using designated TALENs (T27 and T512) targeted HPV16 E6 and E7 produced disruption of HPV16 E6 and E7 DNA, decreased the expression of E6 and E7 proteins, and induced cell apoptosis.

This study will evaluate the safety and efficacy of and T512 in treating HPV Persistency and HPV16-positive CIN.

Eligibility Criteria:
Inclusion Criteria:

* Documented HPV16 infection and integration.
* Married and fertile, no fertility requirements.
* The cervical transformation zone was type I or II, and the biopsy results under colposcopy suggested SIL.
* Without administration of hormone in the last six months
* Subjects must be meet the ethical requirements and have signed informed consent

Exclusion Criteria:

* Pregnancy and breast feeding
* Any bacterial vaginitis
* Any Fungal vaginitis
* Any sexually transmitted diseases
* Active drug or alcohol abuse
* Any HPV medications within the past 12 weeks
* Allergy to active or non active ingredients in the study of drugs
* Cardiac insufficiency
* Liver and renal insufficiency
* Hypertension and severe complications
* Serious illness in past 30 days
* Currently participating in another clinical trial or any prior gene therapy
Comparison Between NEOSORB Plus and NEOSORB

This study is to investigate whether NEOSORB Plus antibacterial suture (chlorhexidine diacetate coated PGLA910) is not inferior to NEOSORB suture (PGLA910) in the points of intraoperative handling.

1. Enrollment

   1. Urologic surgery which needs fascia and subcutaneous tissue repairs
   2. Clean and clean-contaminated surgery
   3. Patients aged more than 18 years and under 80 years
2. Randomization

   1. NEOSORB Plus (chlorhexidine diacetate coated PGLA910) or NEOSORB (PGLA910) suture
   2. Stratification by operative methods: Open surgery vs. laparoscopic or robot-assisted laparoscopic surgery
3. Follow-up with 30 days

   1. Primary endpoint: intraoperative handling during operation
   2. Secondary endpoint: wound healing assessment on postoperative 1st (+1) days and 11th (± 4) days
   3. Safety evaluation: counting adverse events within postoperative 30 days

Eligibility Criteria:
Inclusion Criteria:

* Urologic surgery which needs fascia and subcutaneous tissue repairs
* Clean and clean-contaminated surgery

Exclusion Criteria:

* Contaminated surgery
* Wound requiring retention suture
* Suspicious malnutrition status
* Active infection status or AIDS
* Incision sites prone to expand, stretch, distend, or require support
* Allergy or hypersensitivity to chlorhexidine diacetate
* Significant active medical illness which in the opinion of the investigator would preclude protocol treatment