cyrilzakka/clinical-trials huggingface dataset:
Early Blocking Strategy for Metachronous Liver Metastasis of Colorectal Cancer Based on Pre-hepatic CTC Detection

In this study, the Quintuple method was applied for early intervention of prehepatic CTC-positive bowel cancer patients without dominant liver metastasis, aiming to explore the blocking effect of the Quintuple method on the metachronous liver metastases of colorectal cancer. A one-arm randomized clinical trial was conducted, and the patients were grouped according to their treatment methods. The patients with metachronous liver metastases were used as the end point of the experiment to evaluate the blocking effect of quintuple therapy.

Patients diagnosed with colorectal cancer, clinical stage I to III, underwent radical surgery, and prehepatic CTC≥1 were enrolled. Patients were randomly divided into Conventional treatment group and Quintuple method treatment group. Patients in the Conventional treatment group received conventional treatment according to the NCCN Guidelines for Colorectal Cancer 2023 edition. For patients in the Quintuple method treatment group, Quintuple method intervention was adopted, that is, combined with SOX regimen chemotherapy, low-dose cetuximab targeted therapy and three-drug regimen of folic acid, vitamin A and metronidazole. Specific drug dosages were as follows: SOX regimen was administered every three weeks, d1 was given oxaliplatin intravenously, the dosage was 130mg/ m2 \* patient's body surface area, d2-d15 was taken orally by Digio, 20mg three times a day each time. Cetuximab combined with chemotherapy was administered intravenously, once every three weeks, before oxaliplatin, and the dosage was 250mg/ m2 \* patient's body surface area. Metronidazole 0.4g/ time, once a day; Vitamin A 25,000 units/time, once a day; Folic acid 0.4mg/ time, once a day. The last three drugs were continued until the end of all chemotherapy cycles. The above regimen lasted for 6 to 8 sessions, and enrolled patients were reviewed every 3 months for colorectal cancer-related tumor markers, including MRI and CT imaging. The primary endpoint was radiographically confirmed metachronous liver metastases, and the secondary endpoint was death, observed for 3 years.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 18-80 at the time of signing the informed consent;
2. Histologically or cytologically confirmed adenocarcinoma of the colon or rectum;
3. Radical surgery has been performed;
4. Imaging examination showed no liver metastasis;
5. Prehepatic CTC number ≥1;
6. The ECOG performance status is 0-1.
7. No combination of other life-threatening diseases;
8. Willingness and ability to follow scheduled visits, treatment plans, laboratory tests and other research procedures.

Exclusion Criteria:

1. Patients with non-primary colorectal cancer;
2. Patients with liver metastasis or other organ metastasis;
3. Patients without prehepatic CTC or whose prehepatic CTC were negative;
4. People who are severely allergic to one or more of the drugs required in the test;
5. Patients with severe underlying diseases of respiratory, circulatory, urinary and hematopoietic systems.
Is There a Correlation Between the Pulmonary Artery Pressure and the Acceleration of the Flow in the Pulmonary Artery Evaluated by Transesophageal Echocardiography (TOE) ?

The measure of the pulmonary artery pressure (PAP) is a very useful index in intensive care to estimate right ventricular after load. The reference technique for this measure is the right catheterism which is an invasive technique. It is possible to estimate the pulmonary artery pressure by using transthoracic echocardiography (TTE) which allows, using the continuous Doppler, the measure of maximum speed of tricuspid regurgitation (TRvmax). The measure of the TRvmax can however be difficult for intensive care patients with little echogenicity or impossible for those having no tricuspid leak. The evaluation of the tricuspid regurgitation is also particularly difficult using TOE. To avoid these drawbacks, one can use the analysis of the pulmonary ejection in the pulmonary artery (PAAT) with TOE. However, the data of the literature are controversial on this method and it was not validated in mechanically ventilated intensive care patients.

The aim of this work is to compare three methods of measure of the PAP: the measure TRVMAX (by means of the tricuspid leak) by transthoracic echocardiography, the measure of the TAAP by transesophageal ultrasound and the direct measure of the pulmonary pressures by right catheterization, in ventilated patients already monitored with a catheter in the right cavities for usual indications in intensive care (ARDS, shock). We shall analyze then the correlation between the TRVmax, the TAAP and the pressures measured by the right catheterism which serves as reference technique.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years
* Admitted to intensive care
* Mechanically ventilated and sedated
* Carrying a right catheterization
* Making a ETO indicated by the medical team or doctor in charge of the patient

Exclusion Criteria:

* Patients under 18 years
* expectant mother
* Patients without health insurance
* Refusal to close
Transferrin Saturation Coefficient and Ferritinemia in Diagnosis of Iron Deficiency

Transferrin saturation coefficient and ferritinemia in diagnosis of iron deficiency


Eligibility Criteria:
Inclusion Criteria:

* ≥ 65 years old
* Patient hospitalized in the internal medicine and geriatry service
* Patient affiliated with a social security scheme
* Patient signed an Informed consent

Exclusion Criteria:

* Risk benefit balance not in favor of iron deficiency check-up
* Patient in palliative care
A Reliability and Validity Study of Urdu Version of Knee Outcome Survey-Activities of Daily Living Scale

The purpose of this study is to translate Knee Outcome Survey-Activities of Daily Living Scale into Urdu language and to check the reliability and validity of the Knee Outcome Survey-Activities of Daily Living Scale in Urdu language for the general population of Pakistan

Approximately 150 participants will be included in the study on the basis of inclusion and exclusion criteria. The English version of the Knee Outcome Survey-Activities of Daily Living Scale will be translated and culturally adapted as per as previous recommendations. In the general population with knee pain,Urdu version of the Knee Outcome Survey-Activities of Daily Living Scale will be distributed among general participants by choosing convenience sampling technique based on predefined inclusion and exclusion criteria. To test inter and intra-observer reliability of the final Urdu version of Knee Outcome Survey-Activities of Daily Living Scale with Knee osteoarthritis outcome survey and Lysholm knee score will be filled within same day, by two observers and for the inter-observers assessment, with an interval of 30 minutes between the first and second application. Third assessment will carry out after 7 days by Observer-1(re-intra-observers assessment. Data will be entered and analyzed by Cronbach alpha value.Test-retest reliability will be assessed using interclass correlation coefficient.

Eligibility Criteria:
Inclusion Criteria:

* Ability to walk without assistive device
* proficiency in the Urdu language
* pain level of at least 30% on the visual analog scale

Exclusion Criteria:

* Other osteoarthropathies with a good history
* If you have a heart condition or are having trouble with your nerves
* A debilitating factor that lowers functional independence and activity levels
* A lower-extremity fracture within the previous six months of the research
* Other joint diseases include ligament, menisci, or patellofemoral issues, as well as severe non-osteoarthritic knee effusion or arthroplasty
Safety, Feasibility and Efficacy of Sulforaphane (Avmacol Extra Strength) in Chronic Kidney Disease

The Sulforaphane Production System® in Avmacol Extra Strength (ES) supplies broccoli seed extract (glucoraphanin) and Myrosimax® (Active Myrosinase Enzyme) which helps promote sulforaphane production in your body. The investigators hypothesize that daily intake of Avmacol ES can decrease kidney disease progression rate and decrease markers of oxidative stress and inflammation in Chronic Kidney Disease (CKD) patients. They will test this hypothesis in a randomized, double-blind, placebo controlled Phase 2 clinical trial. This proposed study has been funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), R01 DK128677.

The investigators will test the safety and efficacy of Avmacol ES in Chronic Kidney Disease (CKD) patients. After having established a safe dose of 4 tablets once daily in participants with CKD Stages 3 - 4 in the pharmacokinetic (PK) phase, the investigators will enroll 100 participants from the Kidney Clinic at the University of Rochester Medical Center and Highland Hospital with CKD stages 3 - 4 who will be randomized to Avmacol ES or placebo in a 1:1 ratio in a blinded manner.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and ≤ 80 years
* Estimated glomerular filtration rate (eGFR) ≥ 20 and \< 60 mL/min/1.73m2 and a decline in eGFR of ≥ 3 ml/min/1.73m2 /year in the previous 12 ± 2 months
* Able to provide consent
* Able to swallow Avmacol ES or placebo capsules

Exclusion Criteria:

* Significant co-morbid conditions with life expectancy of \< 1 year
* Serum potassium of \> 5.5 milliequivalents per liter (mEq/L) at screening
* New York Heart Association Class 3 or 4 heart failure symptoms, known Ejection Fraction (EF) ≤ 30% or hospital admission for heart failure within the past 3 months
* Factors judged to limit adherence to interventions based on appointment attendance and medication treatment compliance; PI will make this determination
* Current participation in another medical intervention study
* Known to be pregnant or planning to become pregnant or currently breastfeeding; determined by self-report and medical record history. A urine pregnancy test will be completed for individuals of childbearing potential before administering the study drug, and repeated thereafter at every study visit (\~ every 3-4 months)
* History of dementia documented in the medical record
* On anticoagulants or immunosuppression
* Under treatment for cancer
* Delayed gastric emptying or similar GI conditions Non-English-speaking individuals are excluded in this randomized phase of the study because the lack of English proficiency will affect a subject's ability to report problems or adverse events. If a patient cannot read, the consent form will be read to them by the research coordinator.
Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection

The purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for the treatment of chronic HBV infection. For the China substudy, patients randomized to entecavir will have safety and efficacy assessments performed during the first year of the study.


Eligibility Criteria:
Inclusion Criteria:

* Chronic HBV infection
* HBV nucleoside/tide-naive or -experienced
* Patients who, in opinion of investigator, are appropriate for initiating or modifying their HBV therapy and who are appropriate for a treatment regimen comprised of nucleoside/tide monotherapy with either ETV or another standard of care HBV nucleoside/tide analogue
* Age 16 and older or minimum age required in a given country

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Patients who, in the opinion of the investigator, are expected to have a liver transplant-free survival of less than one year
* Patients who, in the opinion of the investigator, are virologically controlled on their current treatment regimen and clinically responding to treatment, unless the regimen needs to be modified for medication intolerance
* Coinfection with HIV
* History of malignant neoplasm(s), including hepatocellular carcinoma (HCC) and carcinoma in situ (CIS), but excluding non-melanoma skin cancers
* Patients with chronic renal insufficiency, defined as a creatinine clearance \< 50 ml/min who do not have either of the following means of dose reducing ETV:

  i. an approved country-specific ETV label which includes the extended interval ETV dose modification method and/or ii. an approved country specific label for the ETV oral solution AND access to the oral solution
* History of dysplastic liver nodules
* Known history of allergy to nucleoside/tide analogues
* Prior or current treatment with entecavir
* An investigator proposed study regimen which will include only interferon-alfa
* An investigator proposed study regimen of combination (two or more) HBV nucleoside/tide analogues
Pain Outcomes Following Video-Assisted Thoracic Surgery (VATS) With LAP Protector

The purpose of this study is to see if different types of spreading (rigid or soft) of Video-assisted Thoracoscopic Surgery (VATS) for lung cancer have different effects on pain.

The Lap-Protector (Hakko Co., Japan) is a device that consists of two flexible rings made of superelasticity alloys covered with polyurethane polyamide, and a thin silicone rubber membrane that is attached to the outer rim of the two rings. If the two rings are pulled apart, the device assumes a cylindrical shape. The outer diameter of each flexible ring is 12 cm, and this device can be used for minilaparotomy wounds between 5 and 9cm long.

Eligibility Criteria:
Inclusion Criteria:

* Non-small cell lung cancer stage IB - IIIA
* ECOG status 0-1

Exclusion Criteria:

* Prior chemotherapy and/or radiation therapy for lung cancer
* Peripheral neuropathy \> grade 1
* Concurrent other malignancies, other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Medical condition that will not permit treatment or follow up according to the protocol
* Pregnant or nursing women
* HIV-positive patients
The Effect of Stress on DNA Integrity and the Effect of Cognitive Behavioral Therapy on Stress and Infertility in Women

The general hypothesis of the research is that stress decreases fertility and that Cognitive Behavioral Therapy will reduce stress and increase fertility. Secondarily, we hypothesize that stress has a detrimental effect on DNA integrity and that stress reduction will reduce DNA damage in the cell.


Eligibility Criteria:
Inclusion Criteria:

* women between the ages of 18-35 without children undergoing IVF treatment

Exclusion Criteria:

* undergoing treatment for a DSM-IV axis I psychiatric illness.
Efficacy of Oral Tolerance Induction to Raw Apple

The aim of the study was to describe an intensive ultra rush (UR) protocol of raw Golden apple (RGA) reintroduction in 28 in-patients, show the protocol's tolerance and the patients' follow-up at 2 months and 1 year. Patients with oral allergic syndrome (OAS) having resulted in raw fruits eviction were admitted to day hospital between June 1 2016 and October 31 2017.

The aim of this study was to describe an intensive ultra rush (UR) protocol of raw Golden apple (RGA) reintroduction in 28 in-patients, show the protocol's tolerance and the patients' follow-up at 2 months and 1 year. Patients with oral allergic syndrome (OAS) having resulted in raw fruits eviction were admitted to day hospital between June 1 2016 and October 31 2017.

Methods : Patients were included during the first consultation, UR was performed with RGA in day hospital performed in two institutions, the Charcot clinic and the polyclinic of Beaujolais.

Starting with 1 gram (g) of food, then by regularly doubling dose from 2g to 128g, to reach a 255g cumulative dose in a 3 hour period.

During the the post hospitalization period, patients back home had to eat ½ RGA a day during one month, then 1 RGA a day during one month, together with other rosacea fruits resumption at the end of the 5th week if UR were performed between April 15th and July 15th. A synthesis consultation was made at two months and a telephone interview at one year.

Eligibility Criteria:
Inclusion Criteria:

* No longer eat raw rosacea for at least 6 months due to oral allergic syndrome
* With allergic rhinitis or asthma due to betulaceae pollen (SPT+ and/or IgE + to Bet v 1 \> 0,10 kUA/L)
* With reduced quality of life

Exclusion Criteria:

* With severe allergic reaction to rosacea (\>Grade 3 according to Ring and Messmer's classification)
* Pregnant woman
* Uncontrolled asthma (FEV1 \< 70%)
* Immunosuppressed patient or having malignant disease, current infectious disease, or serious cardiovascular disease
* Opposed to use data
Oral Health Education and Message Framing Effect on Oral Health Status of Refugees in Egypt

Refugees, facing forced displacement and often exposed to traumatic experiences, represent a vulnerable population with unique healthcare needs. Oral health is considered a prominent factor that contributes to quality of life.

Therefore, this study aim at assessing the effect of message framing on enhancing oral health practices in a group of refugees in Alexandria, Egypt. A three-arm cluster randomized controlled clinical trial will compare a gain-framed mobile text messages group, a loss-framed mobile text messages group, and a control group. The primary outcome is the improvement in oral health practices measured by changes in dental plaque and secondary outcome is to assess change in oral health-related quality of life. In addition, oral health knowledge, attitudes, and practices of refugees will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Refugees older than 18 years old.
* From Arabic speaking countries.
* Has been resident in Alexandria, Egypt for at least 6 months.
* Having mobile phones to receive text messages.
* Agrees to participate in the study.

Exclusion Criteria:

* Planning to move away during 1 year study period.
* Participating in any kind of oral health education and promotion programs.
Intermittent Portal and Graft Purge in Living Donor Liver Transplantation

Post-reperfusion syndrome and ischemia-reperfusion insult are a common well-known complication in liver transplantation. Several trials investigated variables that my contribute to the generation of these two complications for reducing their incidence and magnitude. The investigators will investigate the effect of acute conditioning of the recipients circulation to the vasoactive mediators in the graft as well as the congested intestine through intermittent purging of graft contents into the patient's systemic circulation in living donor liver transplantation.

Patients are subjected to living donor liver transplantation. In this type of grafts, cold ischemia time is minimal and the graft contents of preservative solution are less than cadaveric grafts. The investigators in the current research use HTC as a preservative solution. These factors justified the possibility of purging the graft and portal blood contents into the patient systemic circulation. The exposure to these fluids in this trial will be in an intermittent manner: the portal vein will be declamped for 5 seconds followed by 30 seconds of portal clamping. This will be repeated twice. The primary outcome objective in this trial will be the incidence of post-reperfusion syndrome. Secondary objectives include the severity of PRS, the incidence and severity of ischemia-reperfusion injury, graft and patient's survival.

Eligibility Criteria:
Inclusion Criteria:

* living donor liver transplantation recipients

Exclusion Criteria:

* Non
Cladribine Dose Escalation in Conditioning Regimen Prior to Allo-HSCT for Refractory Acute Leukemia and Myelodysplastic Syndromes

The investigators focused on patients with refractory acute leukemia or MDS and designed a phase 1 trial of escalated cladribine doses in the Cla-Flu-Bu RTC regimen using PK-guided myeloablative busulfan doses. This scheme allows combining different optimization of RTC experienced over years (Flu-Bu RTC, PK-guided myeloablative busulfan doses, a second purine analog cladribine) to approach a specific platform to treat refractory diseases.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70
* ECOG 0 or 1
* Acute leukemia (AML or ALL) without criteria for CR or high risk MDS without criteria for CR
* Availability of a donor among following oHLA identical sibling oHaploidentical donor o10/10 or 9/10 allele-level HLA matched unrelated donor
* Signed informed consent
* Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen

Exclusion Criteria:

* Contraindication for Allo-HSCT
* Cord blood Allo-HSCT
* Current active disease or positive serology for HIV, and/or HCV with detectable viremia and/ or HBV with positive Hbs Antigen.
* Renal failure with creatinine clearance \< 30 ml/ min
* Decompensated haemolytic anaemia
* Hypersensitivity to an active substance or to any of the excipients
* Acute urinary infection
* Pre-existing haemorrhagic cystitis
* Woman of childbearing potential not using an effective contraception .
* Pregnant or lactating women
* Any serious concurrent uncontrolled medical disorder
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Filter Lifespan in Continuous Renal Replacement Therapy

The only supportive therapy for patients with AKI is renal replacement therapy (RRT). In the ICU setting, continuous RRT (CRRT) is mostly favored. In a post-hoc analysis of the RICH trial (regional citrate versus systemic heparin anticoagulation for CRRT in critically ill patient with AKI), it was shown that the filter life span is associated with an increased rate of new infection and that the type of anticoagulants did not directly affect infection rate. The mechanisms of this infection rate is unknown.

Approximately every second patient in the ICU suffers from acute kidney injury (AKI) which complicates the clinical course of these patients. Continuous renal replacement therapy (CRRT) has become the most widely used form of renal support in critically ill patients as it allows continuous, controlled removal of fluids and is hemodynamically better tolerated compared to intermittent dialysis. The requirement for intravascular access and artificial circuits may increase the risk of infection. However, there are no studies analyzing the incidence and characteristics of infections in critically ill patients with CRRT or the implications for outcome. Therefore, this observational trial investigates the factors that influences new onset infection in critically ill patients with CRRT.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥18 years)
* Critically ill patients with dialysis-dependent AKI
* Continuous renal replacement therapy (CRRT)
* Written informed consent

Exclusion Criteria:

* Chronic kidney disease with estimated glomerular filtration rate (eGFR)\<30ml/min/1.73m2
* Chronic dialysis dependency
* Kidney transplant
* (Glomerulo-)nephritis, interstitial nephritis, vasculitis
* Patients on immunosuppression
* Patients with chronic inflammatory diseases (e.g. arthritis, HIV, chronic hepatitis)
* Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
Feasibility of Opportunistic Salpingectomy at the Time of Vaginal Hysterectomy for Benign Pathology

In this prospective study, patients who underwent vaginal hysterectomy with salpingectomy or salpingo-oophorectomy were included. The objective of this study is to assess the feasibility of prophylactic salpingectomy during vaginal hysterectomy for benign pathology and the prevalence of occult tubal lesions. The hypothesis is that prophylactic salpingectomy during vaginal hysterectomy for benign pathology present a low failure rate and it makes it possible to avoid the appearance of a certain number of ovarian cancers. The prevalence of bilateral salpingectomy with or without ovariectomy and the prevalence of histopathological and immunohistochemical (p53 expression) abnormalities were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent vaginal hysterectomy for benign pathology with salpingectomy or salpingo-oophorectomy