cyrilzakka/clinical-trials huggingface dataset:
Enhanced Recovery After Laparoscopic Colorectal Surgery Study

The study will assess the impact on quality of care after implementation of the ERAS (Enhanced Recovery After Surgery) protocol for laparoscopic colorectal surgery in Vilnius University Hospital Santaros klinikos. The primary goal of this study is to compare efficacy of two different types of anaesthesia - general and combined (spinal and general), efficacy of multimodal analgesia in both groups, need for rescue analgetics, time to bowel movement, time to ambulation. We also aim to study overall patient satisfaction and measure health-related quality of life, from date of randomisation until the date of hospital discharge, 30 days, 3 months and 6 months post-discharge.

Recovery After Surgery (ERAS) protocol is a multimodal perioperative care pathway designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery, now widely accepted in laparoscopic colorectal surgery.

In laparoscopic colorectal surgery, the ERAS protocol involves an accurate interview with the patient in the preoperative phase aimed at smoking and alcohol cessation, the reduction of preoperative fasting with administration of oral carbohydrates before surgery, use of intestinal preparation for selected cases only, the prophylaxis of thromboembolism, a correct antibiotic prophylaxis, the prevention of intraoperative hypothermia and hypotension, prevention of volume overload, preference for minimally invasive surgery, multimodal analgesia with reduced opioid requirements, local anaesthetics for wound infiltration, prevention of postoperative nausea and vomiting, very limited use of the nasogastric tube, early removal of the urinary catheter, multimodal analgesia to minimize opiate consumption, early postoperative mobilization and early postoperative feeding, to promote rapid recovery of gastrointestinal functions.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older.
* scheduled for laparoscopic colorectal surgery.
* patient informed and having accepted the principle of enhanced recovery after surgery.
* patient written consent will be obtained preoperatively for eligible study participants.

Exclusion Criteria:

Preoperative:

* patients who can not comply with the ERAS protocol because they do not understand the language or has a cognitive disorder.
* patients with a documented allergy to nonsteroidal anti-inflammatory drugs and acetaminophen.
* preoperative renal insufficiency (creatinine clearance less than or equal to 30ml/min) or hemodialysis.
* patients with a history of hepatic impairment.
* chronic pain condition that required daily opioid dependence.

Operative:

* conversion to laparotomy.
Comparison of the Time to Recurrence Between Ranibizumab and Aflibercept

The investigators compared the time to recurrence after ranibizumab or aflibercept loading in patients with AMD.


Eligibility Criteria:
Inclusion Criteria:

* They must have had BCVA better than 20/400 and had three consecutive induction treatment of ranibizumab or aflibercept.

Exclusion Criteria:

* patients with eye diseases that could potentially influence the visual acuity of the studied eye, such as glaucoma, macular hole, diabetic retinopathy, or rhegmatogenous retinal detachment.
Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris

The purpose of this study is to demonstrate the non-inferior efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel when compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel in Subjects with acne vulgaris after a 12-week treatment period.


Eligibility Criteria:
Male or female Subjects of any race, between the age of 12 and 35 years inclusive, with acne vulgaris, meeting specific inclusion/exclusion criteria.

Main inclusion criteria:

1. Male or female Subjects of any race, aged 12 to 35 years inclusive, with facial acne vulgaris,
2. Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face,
3. Subjects with a minimum of 30 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose.

Main exclusion criteria:

1. Subjects with acne cystic lesions,
2. Subjects with acne conglobate, acne fulminancy, secondary acne (chloracne, drug-induced acne, etc.).
The Accuracy of Endometrial Ultrasound to Predict Implantation

To measure the accuracy of different ultrasound endometrial patterns to predict successful embryo implantation during assisted conception; in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).

Ultrasound appearance of the endometrium may predict successful implantation in assisted conception, but studies have yielded conflicting results.

The explanation may be different timing of, and classification systems for, the scan, different treatment protocols, and different definitions of success. Also scan quality has improved over time.

This is a prospective study looking at the endometrial pattern as a predictor of IVF/ICSI outcome, adjusting for embryo quality, ease of transfer, and fresh or frozen cycles. The study will focus on good quality single embryo transfer at the blastocyst stage. Other endometrial ultrasound parameters such as thickness, volume and Doppler will also be measured. Reliability studies will also be conducted to assess and account for inter- and intra-observer variation.

200 women will be recruited. They will include approximately 100 undergoing fresh and 100 undergoing frozen embryo transfer. There will be no change to routine clinical care. A single operator will analyse all ultrasound images to reduce inter-observer variation. When there is uncertainty about the pattern the chief investigator will be consulted to reach an agreement.

Eligibility Criteria:
Inclusion Criteria:

* Female undergoing in vitro fertilisation or intracytoplasmic sperm injection (IVF/ICSI)
* Own or donated eggs
* Informed consent

Exclusion Criteria:

* Known pathology affecting the endometrial cavity (polyp, submucosal fibroid)
* Septate uterus or more complex uterine abnormality.
Plasma Proteomics Study of End-Stage Liver Disease Patients Based on Olink Technology

Exploring Early Biomarkers of Hepatitis B Virus-Related Acute-on-Chronic Liver Failure Using Olink Proteomics

The rationale for this study is that, with the changing epidemiology of liver diseases, traditional diagnostic methods are no longer sufficient to meet clinical needs. Olink technology, however, offers the potential to discover novel biomarkers. By comparing the plasma proteomic profiles of patients with cirrhosis and liver failure, we aim to identify clinically significant markers. This not only has the potential to enhance early diagnostic capabilities but also provides an important basis for personalized treatment.

Eligibility Criteria:
Inclusion Criteria:

* HBV-LC patients were diagnosed based on previous liver biopsy results or clinical evidence and laboratory tests of previous decompensation for more than three months, including ascites, gastrointestinal bleeding, infection, hepatic encephalopathy, or a combination of these symptoms, endoscopic examination (esophageal and gastric varices), and radiological imaging of portal hypertension and/or liver nodules.

The inclusion criteria for HBV-ACHD patients in this study were based on patients with chronic stable decompensated cirrhosis who experienced an acute decompensation within three months. The reference criteria for acute decompensation in the HBV-ACHD group were as follows: patients with previously diagnosed decompensated cirrhosis presenting with a high level of jaundice (total bilirubin ≥5 mg/dL) HBV-ACLF was categorized into three grades based on the severity of the condition. The inclusion criteria for HBV-ACLF-1 were as follows: patients presenting with liver failure alone with an international normalized ratio (INR) ≥1.5 and/or kidney dysfunction and/or hepatic encephalopathy (HE) grade I or II. HBV-ACLF-2 was defined by dual-organ system failure, while HBV-ACLF-3 was characterized by failure involving three or more organ systems.

Exclusion Criteria:

* Associated with other types of hepatitis virus infection or HIV infection, alcoholic liver disease, autoimmune liver disease, drug-induced liver injury; ② Suffering from primary liver cancer or severe heart, digestive, lung, kidney, neurological and psychiatric diseases; ③ Patients with incomplete data and patients unable to participate in the experiment.
Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage AD Having Coexisting svCVD

Rivastigmine, an acetylcholinesterase inhibitor which has been approved by FDA \& HSA, is authorized for use in the treatment of mild to moderate dementia of the Alzheimer's type.

In this trial, the investigators will be studying the effectiveness of Rivastigmine in subjects with AD and cerebrovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Age between 50-85 years
* Diagnosis of dementia of the Alzheimer's type according to the National Institute of Ageing-Alzheimer's Association Criteriah
* MRI brain (with T2 or FLAIR sequences) performed within a 12 month period from time of recruitment demonstrating the presence of WMH of ≥2 on the Fazekas scale (Score range of 0-3 wherein a score of 1 indicates mild WMH, 2 indicates moderate WMH and 3 indicates severe WMH).i
* Clinical Dementia Rating score of 1-2j
* Mini-Mental State Examination (MMSE) scores of 12-26 inclusivek
* English or Mandarin speaking, literate participants

Exclusion Criteria:

* Severe neurological, psychiatric or systemic disease which in the opinion of the clinician could interfere with trial assessments
* The use of any investigational drugs, new psychotropic or dopaminergic agents, cholinesterase inhibitors or anti-cholinergic agents during the 4 weeks prior to recruitment
* Known skin allergy or previous allergic reaction to Rivastigmine patch
Epidemic Profile of Left Ventricular Diastoic Dysfunction in the Community Elderly and Establishing Prediction Model: the Northern Shanghai Study

This study is one of the largest ongoing prospective population studies to evaluate target organ damages (TODs) and Left Ventricular Diastoic Dysfunction in the community-dwelling elderly Chinese, which is authorised and funded by the Shanghai municipal government.This study was approved by the Shanghai Tenth People's Hospital Institutional Review Board and was conducted under financial support from the Shanghai municipal government (grant ID: 2013ZYJB0902 and 15GWZK1002). The preliminary sample size is expected to be 3000-4000 participants.

The Northern Shanghai Study is an ongoing prospective community-based study. After enrolment, clinical examination,anthropometric measurement and a questionnaire will be administered to each participant at baseline and patients will be followed up every six months. Our tests and examinations include: blood/urine sample and biochemical measurements, office blood pressure recording, carotid ultrasonograph, echocardiograph, pulse wave velocity, pulse wave analysis, 4-limb blood pressure recording, body mass index, etc. Baseline measurement will also include the assessments on target organ damages(TODs) and the conventional CV risk factors. In the follow-up, the incidence of CV events and mortality will be recorded. The Northern Shanghai Risk Score will be calculated, with considerations on CV risk factors and TODs.

Eligibility Criteria:
Inclusion Criteria:

1. age 55 years or more
2. informed consent should be signed voluntarily
3. local residents from communities in northern Shanghai and available for long-term follow-up

Exclusion Criteria:

1. was diagnosed with serious heart disease (NYHA≥IV) or end-stage renal disease (CKD ≥4 stage)
2. suffered from cancer or his/her life expectancy is \<5 years
3. had stroke within 3 months
4. is not willing to participate in the clinical study
5. has to quit the trial due to other diseases
6. violates the protocol or loses contact with the laboratory staff.
Acute Response to Left Bundle Branch Area Pacing With SyncAV

This clinical investigation is a prospective, single-arm, post-market, non-randomized, single-center study designed to evaluate the effectiveness of the SyncAV CRT dynamic atrioventricular (AV) delay feature when used with left bundle branch area pacing (LBBAP).


Eligibility Criteria:
Inclusion Criteria:

1. Patient is 18 years of age and willing to comply with the study requirements
2. Patients with approved indication for dual-chamber pacing or cardiac resynchronization therapy and scheduled to be implanted with an Abbott pacing system
3. Patient has documented left bundle branch block (LBBB) or intraventricular conduction delay (IVCD)
4. Patient has an intrinsic QRS duration ≥ 130 ms
5. Patient has intact AV conduction with PR interval ≤ 250 ms

Exclusion Criteria:

1. Patient has a resting ventricular rate \> 100 bpm
2. Patient has AV Block (2nd or 3rd degree)
3. Patient has documented persistent atrial tachycardia or atrial fibrillation
4. Patient has had a recent myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for pacing device programming changes in the opinion of the investigator
5. Patient is currently participating in another clinical investigation
6. Patient is pregnant or nursing
7. Patient has other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
8. Patient does not have legal authority
9. Patient is unable to read or write
Acupuncture for the Treatment of Chronic Lymphedema

Lymphedema is an accumulation of lymphatic fluid in the tissues that causes swelling, most often in the arms and/or legs, and occasionally in other parts of the body. Lymphedema can occur when lymph vessels are damaged or lymph nodes are removed. Lymphedema can develop right after breast cancer treatment or weeks, months, or even years later. For many people, available treatments for lymphedema are not effective. Recent evidence suggests that acupuncture may help reduce the symptoms of lymphedema. The purpose of this study is to determine the effects of acupuncture on chronic lymphedema. This study will look further at whether acupuncture can reduce lymphedema and help us to understand immune changes that may be associated with improvements in lymphedema.


Eligibility Criteria:
Inclusion Criteria:

* Women age 18 or older willing to sign consent.
* Lymphedema in an arm as a result of surgery, chemotherapy, and/or radiation therapy for breast cancer per Breast surgeon or medical oncologist.
* Patients must have received a clinical diagnosis of lymphedema for at least 6 months and no more than 5 years after diagnosis of chronic lymphedema.
* The affected arm must be \>2cm larger than the unaffected arm; this is the standard diagnosis and the one used in the MSKCC studies cited above. The standard measurement techniques will be applied 20.

Exclusion Criteria:

* Previous acupuncture treatment for lymphedema
* Diuretic use
* History of primary (congenital) lymphedema
* Metastatic cancer
* History of autoimmune disorder (including lupus, rheumatoid arthritis, systemic sclerosis)
* History of other fibroproliferative disorder including cirrhosis, pulmonary fibrosis, kidney fibrosis, systemic sclerosis/scleroderma
* Current treatment with corticosteroids
* Treatment with myelosuppressive or stimulatory drugs within 6 months of enrollment
* History of bone marrow transplantation
Lifestyle in Pregnancy and Offspring - Comparison Between Children Born to Obese Women and Children Born to Normal Weight Women

Children born to obese women are at risk of increased adiposity and later adverse metabolic outcomes. We have conducted a follow-up study on an existing clinical trial, called the LiP study (Lifestyle in Pregnancy), registration number NCT00530439,in which 360 obese pregnant women were randomized to either lifestyle intervention or routine obstetric care. This present study follows the children until 3 years of age. We have the hypothesis, that the intervention during pregnancy results in a lower degree of adiposity and metabolic risk factors in the offspring. Clinical examination is taking place at age 2.5-3 years including anthropometric measurements, Dual energy x-ray (DXA) scans and blood samples measuring metabolic markers.In addition, we have included an extra control group of children born to normal weight women, who were not part of a lifestyle intervention program during pregnancy. We have the hypothesis that the children of the normal weight women have a better metabolic profile than the children born to the obese women.


Eligibility Criteria:
Inclusion Criteria:

- All children born to obese women who participated in the LiP study (a randomized controlled trial of lifestyle intervention during pregnancy) and children born at term to healthy women with a normal pregestational BMI.

Exclusion Criteria:

- The children born to normal weight women only: preterm birth, congenital anomalies, maternal gestational diabetes, maternal diabetes mellitus, severe medical conditions in either child or mother.
Early Treatment With Evolocumab in Patients With ST-elevation Myocardial Infarction

This is a prospective, multi-centre, open label, randomised study of Phase II that enrolls patients hospitalized with a diagnosis of ST-elevation myocardial infarction (STEMI), comparing Evolocumab versus Standard of Care.

Primary objective of the study is to assess whether early evolocumab administration reduces infarct size in patients with STEMI undergoing primary PCI.

At least 150 patients will be enrolled to investigate the efficacy and safety of evolocumab administration in the acute phase of STEMI.

Patients will be followed for 1 year after the enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Chest pain or equivalent lasting \> 20 minutes
* ST elevation myocardial infarction scheduled for primary PCI
* Signed written informed consent

Exclusion Criteria:

* Previous myocardial infarction
* Previous percutaneous or surgical myocardial revascularization
* Ongoing treatment with any statin or ezetimibe
* History of congestive heart failure
* Cardiogenic shock at presentation
* Known Pregnancy
* Women of Childbearing Age
* Known major active infection or major hematologic, renal, hepatic, or endocrine dysfunction
* Malignancy (except non-melanoma skin cancer, cervical in situ carcinoma, breast ductal carcinoma in situ, stage 1 prostate carcinoma) within the last 10 years
* Patients with hypersensitivity to the active substance (evolocumab) or to any of its excipients
* Inability to attend the scheduled clinical evaluation and laboratory tests
* Inability to undergo the pharmacological treatment or other procedures of the study
* Currently enrolled in another investigational drug study, or \< 30 days/\<5 half-life since ending another investigational drug study(s).
Alisertib in Chemotherapy-pretreated Urothelial Cancer

Background:

Progress in developing new effective therapies in advanced and relapsing urothelial cancer has been stagnant in the last few decades and a paradigm shift is desperately needed. Aurora kinase-A overexpression has been previously described in bladder cancer and spindle checkpoint dysregulation is a common feature of human urothelial carcinoma (UC).

Alisertib (Millennium Inc.) is an orally available, selective small molecule inhibitor of Aurora A kinase. Single agent and combination treatment of MLN8237 with either paclitaxel (TXL) or gemcitabine synergistically reduced UC cell viability compared with either drug alone. Hence, sequential application of MLN8237 and TXL warrants clinical investigation. Phase 1 trials of both single agent and the combination with TXL defined the recommended doses for phase 2 trials.

Methods:

A multistep approach will be adopted for this Phase 2 trial. A single-group run-in phase will be conducted first with Alisertib 50 mg orally BID for 7 days, followed by 14d rest until disease progression. In case of activity, a confirmatory randomized (1:1) trial of weekly TXL plus either Alisertib or Placebo will follow, incorporating efficacy and futility boundaries for early stopping. In a single-blind design, TXL will be given on days 1,8,15 q4wks at the dose of 60 mg/m2 with alisertib and 80 mg/m2 with placebo. Alisertib dose will be 40 mg BID days 1-3, 8-10 and 15-17, q4wks.

In the single-arm phase, primary endpoint (EP) will be Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 response-rate. 20 pts will be accrued, ≥3 responses will be required (10% type I and 20% type II error constraints). An accrual of 110 pts is foreseen in the randomized phase. Primary EP: progression-free survival (PFS), assuming an improvement in PFS from a median of 2.5 months (H0) to a median of 4.5 months (H1) (44% hazard rate reduction, 10% drop out rate).

Eligibility will include diagnosis of metastatic UC and failure of 1-2 CT regimens (single-arm) or 1 prior CT only (randomized phase). A relapse within 6 months of a peri-operative CT will be counted as 1 line. Computed tomography and PET will be done every 2 cycles (2 months). Additional pharmacodynamic and translational analyses are planned on pre- post- blood and tissue samples.

Phase 2 trial. A single-group run-in phase will be conducted first with Alisertib 50 mg orally BID for 7 days, followed by 14d rest until disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of transitional cell tumors of the bladder or the urothelium.
* Locally advanced (T3b,N0; every T,N+) or metastatic disease.
* Failure of max.2 chemotherapy regimens for metastatic disease (at least 1 including a platinum compound).
* Neoadjuvant/adjuvant therapy considered if relapse occurred within 6 months of the last cycle of chemotherapy.

Exclusion Criteria:

* Failure to meet the eligibility requirements.
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Major co-morbidities as specified in the protocol.