cyrilzakka/clinical-trials huggingface dataset:
the Long-term Retention Rate and Influence Factors of Individualized Treatment of Vedolizumab in Ulcerative Colitis

The drug retention rate of vedolizumab for ulcerative colitis decreases with time. This study analyzed the long-term drug retention rate and its influencing factors in patients with moderately to severely active ulcerative colitis treated with vedolizumab.

Vedelizumab is a humanized monoclonal antibody that specifically recognizes α4β7 heterodimer, selectively blocks the interaction between mucosal addressin cell adhesion molecule-1 (MAdCAM-1) on intestinal blood vessels and α4β7 integrins on the surface of lymphocytes, inhibiting the migration of lymphocytes to the gastrointestinal mucosa and thus exerting anti-inflammatory effects. The regimen of vedolizumab therapy for the treatment of ulcerative colitis is intravenous vedolizumab (300 mg) at weeks 0, 2, and 6 for induction therapy, followed by intravenous vedolizumab (300 mg) every 8 weeks for maintenance therapy. This study analyzed the long-term drug retention rate and its influencing factors in moderately and severely active UC patients treated with VDZ, aiming to provide a more precise and personalized treatment plan for UC patients before initiating VDZ therapy, and to better predict drug efficacy as well as retention rate.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with moderate to severe ulcerative colitis
2. Receiving treatment with vedolizumab

Exclusion Criteria:

1. Combination therapy with other biological agents, small molecule drugs, immunosuppressants or hormone therapy.
2. Combination of active tuberculosis, Clostridium difficile infection, cytomegalovirus infection, EBV infection, etc.
3. Combined with malignant tumors or autoimmune diseases (such as dry syndrome, systemic lupus erythematosus, rheumatoid arthritis, etc.).
4. Combined with serious cardiovascular and cerebrovascular diseases or liver and renal insufficiency.

   * Loss of visit or clinical data ≥30% during the follow-up period.
COVID-19 Induced Telogen Effluvium

This study inquires about the development of Telogen effluvium following the SARS-CoV-2 infection

Telogen effluvium (TE) is one of the most common causes of non-scarring alopecia. During the COVİD-19 pandemic, there is an increased number of Telogen effluvium patients.This study inquires about the development of Telogen effluvium following the SARS-CoV-2 infection and correlation between the severity of covid-19 and TE.

Eligibility Criteria:
Inclusion Criteria:

* Sars-CoV-2 infection in the past year

Exclusion Criteria:

* Other common causes of Telogen effluvium ( such as anemia, iron deficiency, thyroid dysfunction)
Studying the Effectiveness of Early Invasive Treatment in Elderly Patients With High-risk Non-ST-segment Elevation Acute Coronary Syndrome.

The goal of this is observational study is to compare about MACE events and predisposing factors related to MACE events in elderly patients with high-risk non-ST acute coronary syndromes receiving early versus late invasive treatment . This study will anwser two questions.

Question 1: What will factors associate with implementing a late invasive strategy in elderly patients with high-risk non-ST-segment elevation acute coronary syndrome ? Question 2: Is a meaningful difference about mortality and complication rates as re-myocardial infarction, heart failure, re-hospitalization, stroke after 12 months between two groups of patients undergoing early invasive and late invasive strategies in elderly patients with in high-risk non-ST-segment elevation acute coronary syndrome?


Eligibility Criteria:
Inclusion Criteria:

* aged 60 years and older
* high - risk non-ST-segment elevation acute coronary syndrome (according to the 2023 European Heart Association recommended standards).
* receives reperfusion intervention.

Exclusion Criteria:

* Acute coronary syndrome due to stent thrombosis, or coronary artery bypass graft occlusion.
* Incomplete medical records.
First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer

The purpose of this study is to evaluate the role of an additional intraperitoneal chemotherapy with cisplatin and etoposide in bulky advanced epithelial ovarian cancer.

This exploratory trial is to compare the efficacy of sequential chemotherapy, intraperitoneal chemotherapy followed by intravenous chemotherapy, versus intravenous chemotherapy alone in the first-line therapy for ovarian cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years to ≤ 75 years.
* Epithelial ovarian cancer with pathology confirmed stage IIIc or IV, expect for lymph node metastasis alone
* Optimal cytoreductive surgery, including hysterectomy, bilateral salpinges-oophorectomy, omentectomy, and resection of all metastatic lesions, with a residual disease no more than 1cm
* Available to receive intraperitoneal chemotherapy 5-10 days postoperative, or no more than postoperative 14 days for those with bowel resection.
* ECOG performance 0-2.
* No more than 3 cycles of chemotherapy prior to surgery.
* Laboratory testing within 7 days of registration: hematopoietic: absolute neutrophil count greater than 1,500/mm3; Platelet count greater than 100,000/mm3. Hepatic: bilirubin less than 1.25 times upper limit of normal (ULN); Bilirubin \< 2.0, SGPT less than 2 times ULN. Renal: creatinine less than 1.6 mg/dL, OR creatinine clearance greater than 40 mL/min.
* Comply with intraperitoneal chemotherapy and follow-up.
* Written informed consent.

Exclusion Criteria:

* Low-malignant potential ovarian tumor.
* Laboratory testing insufficiency. Hemoglobin \< 10 g/dL. Renal insufficiency with serum creatinine \> 1.6.
* Bone marrow dysfunction: absolute neutrophil count less than 1,500/mm3; Platelet count less than 80,000/mm3.
* Active infection.
* Clinically significant gastrointestinal abnormalities.
* Active coronary artery disease, cerebrovascular disease, restrictive or obstructive pulmonary disease, or congestive heart failure.
* Other condition that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
* Prior invasive malignancies within the last 5 years showing activity of disease.
Neutrophil CD64 for Early Diagnosis of Nosocomial Infection in Preterm Newborns

Diagnosis of late-onset sepsis is difficult in the absence of specific clinical signs and biological markers in the infection initial phase .The aim of this study is to determine the performance of a new infection marker : Neutrophil CD64 for early diagnosis in nosocomial infection (NI) in preterm newborns.

METHODS :

* Monocentric prospective study including preterm newborn infants (\<37 weeks of gestationnal age ) with clinical suspicion of nosocomial infection in a neonatal intensice care unit (Neonatal intensive care unit of Montpellier, France).
* Patients will be enrolled in the study after informed consents. Rapid and automated CD64 measurment will be realized during the conventional blood sample including C-Reactive Protein (CRP), Procalcitonin (PCT) and blood culture.
* Broad-spectrum antibiotic therapy can be started on the advice of clinician and blinded the result of CD64. Patients will be then classed in three groups using CDC criteria (center for disease control) : 1-no infection, 2-infection, 3-possible infection during the multidisciplinary staff. Specificity, sensitivity, negative and positive value of CD64 will be calculated and the performances of CRP, PCT and CD64 will be compared.

  153 patients are needed in the study enrolled during a period of 12 months.

PERSPECTIVES Neutrophil CD64 monitoring might be help clinicians to manage nosocomial infections in neonates.CD64 allow to integrate in a decision algorithm with the determination of the best cut-off value to faster processing nosocomial infections and could help to reduce unnecessary antibioc therapy. A rapid technique for determination of CD64 should be readily available in our unit.


Eligibility Criteria:
Inclusion Criteria:

* preterm newborn (\<37 weeks of gestationnal age )
* undergoing symptoms of late-onset-sepsis
* written informed consent obtained from the parents

Exclusion Criteria:

* patient undergoing antibiotic therapy
* patient undergoing surgery in the last seven days,
* patient with severe congenital malformation
* necrotizing enterocolitis
* parents unable to understand the purpose of the study
* no affiliation to social security
Pilates and the Pelvic Floor: A Quasi-experimental Study

In this paper, it is postulates that in pregnant women, the practice of PM led by a qualified professional for a period of four weeks can reduce the incidence of pelvic floor dysfunction (PFD) by decreasing the number of birth injuries.

It is postulated that in pregnang women, the practice of PM can reduce the severity of birth injuries.

Our main objective was to determine the effectiveness of a PM program to reduce the incidence and degree of intrapartum perineal injuries as a way to reduce the incidence of female PFD.

Secondary objectives were:

Assess the role of a MP program on the systolic and diastolic blood pressure. Determine the effect of a MP program on body weight (BMI).

It is a parallel group clinical trial with an allocation ratio of 1:2.

All pregnant women will be informed about the nature of the clinical trial. There will be no differences in the pregnant´s follow-up because it will be performed by two same Pilates monitor with the same formation.

Once the pregnant women is assigned to an arm of the study, those assigned to the intervention group will be sent to the Pilates monitor to explain and initiate the exercise of MP program while the control group will be informed to maintain their usual monitoring of pregnancy.

In the initial visit, the type of physical activity will be evaluated by filling in the international physical activity questionnaire (IPAQ).

Eligibility Criteria:
Inclusion Criteria:

* To go to the Maternal Education program.
* Give your written consent to participate in the study.
* Singleton pregnancy.
* Low-risk pregnancy.
* No contraindication to physical exercise.
* Age equals or more than 18 years old.

Excusion Criteria:

* Pregnant women with poor pregnancy control.
* Difficulty in speaking or understanding Spanish.
* Required a C-section during delivery.
* Refusal to participate in the study.
Survival Outcomes of Uterine Cervical Malignancies in Chinese Population

This study aims to determine survival outcomes (overall survival and progression-free survival) of primary malignancies of uterine cervix in China and relevant risk factors in a prospective cohort study.


Eligibility Criteria:
Inclusion Criteria:

* Primary malignancies of uterine cervix.

Exclusion Criteria:

* Secondary malignancies of uternie cervix.
A Safety Study of Balsamic Bactrim in Pediatric Participants With Acute Bronchitis

This pilot, multicentric and observational study will assess the safety of sulfamethoxazole + trimethoprim + guaifenesin (Balsamic Bactrim) in pediatric participants with acute bronchitis. Administration of treatment will be according to treating physician's recommendation under local labeling.


Eligibility Criteria:
Inclusion Criteria:

* Participants starting treatment with Bactrim Balsamic suspension
* Participants with a clinical diagnosis of acute bronchitis (cough with or without sputum production less than 30 days) according to the medical criteria

Exclusion Criteria:

* Participants who have started treatment with another antibiotic at the time of the visit
* Participants with no respiratory infections
* Participants with mental disorders that do not permit the clinical evaluation of the participant according to the treating physician's criteria
* Participants with severe hepatic parenchymal damage
* Participants with severe renal failure making it difficult to monitor drug plasma concentration
* Participants with hypersensitivity to any of Balsamic Bactrim active ingredients, excipients, and/or sulfas
Efficacy and Safety of Fruquintinib With Sintilimab as First-line Therapy in Gastric Cancer

The goal of this clinical trial is to explore the efficacy and safety in patients with gastric adenocarcinoma or adenocarcinoma of esophagogastric junction. The main questions it aims to answer are:

* Does this therapy have a promising efficacy?
* Does this therapy have a manageable toxicity? Participants will receive fruquintinib plus sintilimab as first-line therapy for gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmed advanced, recurrent, of metastatic gastric adenocarcinoma or adenocarcinoma of esophagogastric junction;
* ECOG PS: 0-2;
* Adequate hepatic, renal, heart, and hematologic functions;
* At least one measurable lesion (according to RECIST1.1);
* Haven't received any systematic treatment for the cancer involved;
* Expected survival \> 12 weeks;
* Contraception until 6 months after the study termination;
* Signed informed consent.

Exclusion Criteria:

* Her-2-positive gastric cancer, or exposed to any immune checkpoint inhibitor;
* Participated in another study;
* Immunodeficiency;
* Received allograft；
* Unmanageable hypertension, diabetes, or coronary disease;
* Have difficulty in taking medicine, or active bleeding;
* Pulmonary tuberculosis, or interstitial lung disease that needs steroid therapy;
* Infection of HIV, HBV, HCV, or other unmanageable infection;
* Other malignant tumor history;
* Allergic to the test drug;
* Other diseases which will affect the results of this study;
* Received resection of stomach;
* Taking anti-tumor traditional Chinese Medicine;
* Severe active bleeding.
A Study Comparing Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Every 4 Weeks Mircera Versus Epoetin Beta in Dialysis Patients With Chronic Renal Anemia.

This two arm study will compare the maintenance of hemoglobin levels, safety and tolerability of once every 4 weeks subcutaneous administration of Mircera versus epoetin beta in dialysis patients with chronic renal anemia. Patients will be randomized to receive either subcutaneous Mircera (starting dose 120, 200 or 360 micrograms) every 4 weeks or subcutaneous epoetin beta in accordance with the prescribed dosing information. In both groups, the starting dose will be the same as the previous dose of epoetin beta administered in the week preceding first study drug administration. Patients will be treated for 28 weeks with follow up 4 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* male or female patients, \>=18 years of age;
* chronic renal anemia;
* Hb concentration 10.0 - 12.0 g/dL during the screening period;
* continuous subcutaneous maintenance therapy with epoetin at the same dose AND same dosing interval for at least 12 weeks before and throughout screening.

Exclusion Criteria:

* blood transfusion within the previous 8 weeks;
* poorly controlled hypertension;
* significant or acute or chronic bleeding;
* active malignant disease;
* congestive heart failure (NYHA Class IV).
Intervention With Lupin Protein-enriched Foods in Hypercholesterolemic Subjects

The objective of the study is to elucidate the effects of lupin protein (Lupinus angustifolius Boregine) as part of a mixed diet on cardiovascular risk factors and to clarify the role of arginine, one of the most abundant amino acids in lupin protein.

The study is based on a previous finding that a daily dosage of 25 g lupin protein isolate, administered as protein drinks, is capable to influence the plasma lipids positively.

Consequently, the physiological effects of a mixed diet containing 25 g lupin protein isolate per day will be investigated compared to 1) a diet containing 25 g of milk protein as well as to 2) a diet with 25 g milk protein and additionally the amino acid arginine supplemented daily.

A double-blinded, controlled, randomized cross-over trial will be performed. Altogether 75 volunteers with hypercholesterolemia will be divided into three groups of 25 subjects each. After a run-in period (baseline), the first group will consume foods with lupin protein isolate (group A), the second group will receive the same foods with milk protein isolate (group B) and the third group will consume the foods with milk protein and 1,6 g arginine per day over a period of four weeks. After a wash-out period of six weeks, the diet will be crossed within the three groups for a second intervention period of four weeks. After another wash-out period, diet will be crossed within the three groups once again.

Arginine will be provided as capsule (1,6 g per day = four capsules per day) in one of the two groups receiving foods with milk protein. In the other groups (receiving foods with lupin protein or milk protein only) four placebo capsules will be served, containing mannitol.

Eligibility Criteria:
Inclusion Criteria:

* Moderate Hypercholesterolemia (total cholesterol \>= 5.2 mmol/L)
* Age: 20-80 years

Exclusion Criteria:

* Intake of lipid-lowering pharmaceuticals
* Allergy against legumes
* Intolerance or allergy against milk
* Pregnancy, lactation
* Chronic bowel diseases
Optimizing Parameters for Long-pulsed Nd:YAG Laser for Reducing Hair Shaft Diameter

This study evaluates the optimizing parameters of long pulse Nd:YAG Laser for reducing the size of hair shaft diameter of the donor for hair transplantation. All participants will receive long-pulsed Nd-YAG laser treatments with three different parameters at the occipital area.

Since the beginning of hair transplantation era, hair transplant technique has been greatly improved to achieve the best natural looking of hairline and hair density. Most Asians tend to have large size of hair shaft at the donor area, which often cause unnatural look of the hairline at the frontal area after hair transplantation due to the contrast between the transplanted hair and the original hair.

The idea of reducing the size of the hair shaft in the certain part of donor area before being transplanted to the frontal hairline becomes appealing. This transection is being practiced extensively in the field of cosmetic medicine by using long-pulsed Neodymium-Doped:Yttrium Aluminum Gamet (Nd:YAG), a laser treatment for permanent hair removal and vascular lesions.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, aged 25-60 years with AGA or healthy
* Completed informed consent form

Exclusion Criteria:

* Pregnancy or breastfeeding
* Acute infection on the scalp or any systemic infection
* Immunocompromised host
* Chronic wasting diseases
* Use of any medications which may affect hair loss such as anticoagulants, anti-hypertensive, hormones, anticonvulsants, retinoid, mood stabilizers and antidepressants
* Unstable medical problems which may affect hair loss such as thyroid diseases, autoimmune diseases, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, congestive heart failure, cerebrovascular accident and psychiatric problems
* Hair thinning at the occipital area
A Study of Effects of Delay in the First Bathing Time of Body Temperature and the Rate of Exclusive Breastfeeding

Using delaying the first bathing by 8 hours as an interventional measure, considering the consistent effect of physiological maturity, newborns with a gestational age of ≥37 weeks were selected as the subjects in the nursery cases, and randomly assigned to the delayed bathing group and the routine bathing group , 10 minutes before bathing, immediately after bathing, 10 minutes, 30 minutes, and 60 minutes to analyze the differences in body temperature of the cases, and the differences in the rate of exclusive breastfeeding at discharge.

The subjects of this study came from newborn babies in the nursery of a teaching hospital in the northern region. The research design was reviewed and approved by the Human Trials Committee. Can freely choose whether to participate in the research project or withdraw, willing participants to inform the research project and fill in the consent form and basic information form, inform that they can withdraw at any time during the research period, and divide the participating infants into the experimental group and the control group through a random allocation form , after the newborn arrives in the baby room, the nursing staff will evaluate the newborn, and then perform an oil bath with baby oil to remove the fetal fat on the body, and then follow the newborn bathing procedure of our hospital. Wash the whole body with water, about 1-2 hours after birth; the control group took the first bath as usual; the experimental group postponed the last step of washing the whole body after washing the face and head to 8 hours after birth , personnel must wear gloves to take care of newborns before bathing. The bathing process was performed by nurses in the baby room. Body temperature was measured 10 minutes before, immediately after, 10 minutes, 30 minutes, and 60 minutes after bathing, and the exclusive breastfeeding situation at the time of discharge was counted. After all measurements are completed, a 100 yuan supermarket coupon will be given.

Eligibility Criteria:
Inclusion Criteria:

* Apparently normal newborn with status ranging from normal to good
* mean gestational age ≥37 weeks
* birth weight ≥2500 g
* Apgar score of at least 7 within 1-5 minutes
* birth rectal temperature ≥36.5°C
* without any major change or signs or symptoms of sepsis.

Exclusion Criteria:

* The mother is younger than 20 years old
* has recently had symptoms of fever, leukocytosis, respiratory tract infection or urinary tract infection
* the mother has diseases such as diabetes, hyperthyroidism, and a positive history of type B streptococcus or other blood and body fluid infectious diseases.
Improving Patient Outcomes Through the Implementation of an IBD Biologic Care Pathway

Inflammatory Bowel Disease (IBD) includes a group of chronic inflammatory conditions of the gastrointestinal system and is composed of Crohn's disease and ulcerative colitis. As an immune-mediated disease, IBD treatment options include the use of biologic medicines including anti-tumor necrosis alpha factor (also called anti-TNFs) medication. Despite biologic medicines being an important part of IBD management, there is inconsistency in the way these medications are used. Implementation of evidence-based, standardized biologic care pathways (BCP) can improve treatment related outcomes. Previous research has shown that using a clinical care pathway, such as a BCP, is a feasible method to support clinical decision making and may improve disease-related outcomes for patients. The researchers propose a prospective study to determine how well a BCP can be incorporated into clinical practice, improve patient health outcomes, and reduce healthcare system redundancies. Also, the impact of a BCP on outcomes for patients treated with the help of a standardized BCP compared to those in patients treated without the use of a BCP will be studied. The results of this study will inform how best to incorporate evidence-based BCPs into real-world practice and support the wide-spread adoption of BCPs in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to age 18
* Starting an Anti TNF biologic therapy or Biosimilar

Exclusion Criteria:

* High-grade, symptomatic fibrostenotic strictures
* Perforating complications
* Intraabdominal or perianal abscesses
* Active infection,
* Known malignancy
* Any contraindication to biologic therapy