cyrilzakka/clinical-trials huggingface dataset:
Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA

The purpose of this study is to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease who are on dialysis and are not taking any treatment to increase their red blood cell production.

Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The presence and severity of anemia are related to the duration and extent of kidney failure. Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function, and increased left ventricular hypertrophy and heart failure.

Erythropoiesis stimulating agents (ESAs) have been established as a treatment for anemia in chronic renal failure subjects, and have improved the management of anemia over alternatives such as transfusion. Peginesatide is a parenteral formulation developed for the treatment of anemia in patients with chronic kidney disease. Peginesatide binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents.

Eligible participants were randomized in equal proportions to two peginesatide treatment regimens, in which participants received peginesatide once every 4 weeks, and one control, epoetin alfa, treatment regimen, in which participants received epoetin alfa three times per week. Total commitment time of this study was a 4 week screening period followed by a minimum of 7 months of treatment.

Eligibility Criteria:
Inclusion Criteria

1. On hemodialysis for chronic renal failure for at least 2 weeks prior to randomization.
2. Two consecutive hemoglobin values of ≥ 8.0 g/dL and \< 11.0 g/dL within the 4 weeks prior to randomization.

Exclusion Criteria

1. Females who are pregnant or breast-feeding.
2. Prior treatment with an erythropoiesis stimulating agent (ESA) in the 12 weeks prior to randomization.
3. Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule.
4. Known bleeding or coagulation disorder.
5. Known hematologic disease or cause for anemia other than renal disease
6. Poorly controlled hypertension.
7. Evidence of active malignancy within one year.
8. A scheduled kidney transplant.
PI3K Delta Inhibitor in Relapsed / Refractory Autoimmune Hemolytic Anemia Patients After Receiving Two or More Lines of Therapy

This is a prospective, multicenter, single-arm, pilot study. The aim of this study is to evaluate the efficacy and safety of Linperlisib, the PI3K delta inhibitor for autoimmune hemolytic anemia patients who failed the second line therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age ≥ 18 years
* Diagnosis of primary warm antibody hemolytic anemia (AIHA).
* Hemoglobin \< 100g/L
* Refractory to or relapsed after at least 2 prior treatment line.
* ECOG performance status ≤ 2
* Willing and able to comply with the requirements for this study and written informed consent.

Exclusion Criteria:

* Neutrophils counts \< 0.5×10\^9/L or platelet counts \< 50 x 10\^9/L
* Diagnosis of any of the following diseases: Cold agglutinin disease, cold agglutinin syndrome, mixed AIHA, paroxysmal cold hemoglobinuria (PCH).
* Diagnosis of the active stage of the connective tissue or systemic autoimmune rheumatic diseases (SARDs)
* History of lymphoproliferative neoplasms
* Had other inherited or acquired hemolytic diseases.
* Secondary AIHA caused by drugs or infection
* Previously received organ or stem cell transplantation.
* Had malignant tumor within 5 years before enrollment, exclusive of cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial tumor, cervical carcinoma in situ or other indolent tumors
* Patients with HBV, HCV, HIV or other infections that require treatment.
* Abnormal liver function: two consecutive examinations with an interval of ≥1 week suggest that ALT and AST are 2.5 times higher than the upper limit of normal values
* Renal impairment: creatinine clearance \<60ml/min
* Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including clinically significant cardiac diseases, refractory hypertension, metabolic disorders and other diseases that seriously affect the function of the gastrointestinal tract.
* Had a history of any psychiatric diseases, cerebrovascular disease or cognitive sequelae of head injury.
* Received rituximab in 6 weeks before enrollment.
* Received attenuated vaccine 4 in weeks before enrollment
* Participation in another clinical trial within 4 weeks before the start of this trial
* Have an allergy to Linperlisib or any other part of this medicine.
* Previously treated with other PI3Kδ inhibitor.
* Pregnant or breast-feeding patients
* Patients considered to be ineligible for the study by the investigator for reasons other than the above
Arthroscopic Partial Meniscectomy Versus Exercise Therapy for Meniscal Injuries in Older Patients, a 5 Year Follow up.

Arthroscopic partial meniscectomie (APM) offers little short-term to medium-term benefit above sham surgery or non-surgical management for knee function in most patients with a symptomatic degenerative meniscus tear. It is suggested that APM is associated with increased risk of accelerated progression of knee osteoarthritis in middle-aged to older patients.

With the 5 year follow-up of the ESCAPE trial we will investigate the longterm results of APM and physical therapy in patients with a meniscal tear over 45 years old.


Eligibility Criteria:
Inclusion Criteria:

* 45 to 70 years old MRI confirmed, non-obstructive and symptomatic meniscal tear

Exclusion Criteria:

* Knee locking or trauma leading to acute surgery;

  ▸ Associated injuries on the index knee consisting of:
* Symptomatic partial or total tear of the anterior cruciate ligament (ACL),
* Posterior cruciate ligament tear,
* OA of the knee, grade 4 on the Kellgren and Lawrence Grading Scale,
* An injury to the lateral or posterolateral ligament complex with significant laxity;

  * Previous knee surgery on the index knee (with the exception of diagnostic arthroscopy);
  * Tumour that is suspected of malignancy, detectable on MRI;
  * Obesity with a body mass index \>35;
  * American Society of Anesthesiologists (ASA) class 4 or 5 patients;
  * General disease that effects physical function or systemic medication/abuse of steroids;
  * Any other medical condition or treatment interfering with the completion or assessment of the trial, for example, contraindications to MRI or surgery;
  * Drugs or alcohol abuse;
  * Patients unable to fill out the Dutch questionnaires.
Thromboelastometry as a Predictor of Thrombotic Complications During Pediatric Recipient Liver Transplantation

The study aims to correlate the perioperative results of a device called thromboelastogram, which is used to detect coagulation abnormalities, with thrombotic complications during pediatric recipient liver transplantation.

Pediatric patients undergoing liver transplant are at risk for significant bleeding and thrombotic complications. Studies in both pediatric and adult cohorts estimate an incidence of thrombotic events in up to 26% of cases. Hepatic artery and portal vein thrombosis (PVT) are reported at rates of 5-15% in pediatric cohorts, which is three to four times the incidence in adults. Bleeding estimates are harder to quantify given variability in the definition of major bleeding, but range from approximately 5 to 9%.The contribution of bleeding to morbidity is difficult to quantify, but thrombotic complications are known to reduce graft survival and contribute significantly to adverse outcomes, with mortality rates approaching 50% in those with hepatic artery thrombosis.

Thromboelastometry offers rapid, comprehensive, and global clinical assessment of the patients' coagulation status, as demonstrated by several studies.

Little data exists in the use of thromboelastography (TEG) in pediatric liver transplantation. In 2011, Curiel et al implemented pre-transplant TEGs for patients listed for liver transplantation. The invistigators sought to examine if there were any correlations with preoperative hypercoagulable indices on the TEG and postoperative thrombotic complications.The invistigators have identified that a preoperative hypercoagulable TEG portends to thrombotic complications in pediatric liver transplant patients. Further studies are needed to explore perioperative management strategies for high risk patients to prevent the development of postoperative thrombotic complications based upon preoperative TEG studies. That's why the invistigators will study the perioperative thromboelastometry as a predictor of thrombotic complications during pediatric recipient liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participant must be between 3 months and 15 years of age.
* Participant is a recipient of a first liver allograft from living donors.
* Participant is a single-organ recipient (liver only).
* Participants' parent/guardian is capable of understanding the purposes and risks of the study and must sign an informed consent for the study.

Exclusion Criteria:

* Pre-existing blood disease.
* A history of liver transplantation.
* Multivisceral transplantation.
* Participants' parent/guardian refused to participate in the study.
Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

To conduct an unblinded pragmatic randomized controlled trial (pRCT) "Improvement of PPROM Management with Prophylactic Antimicrobial Therapy (iPROMPT)" of a seven-day course of ceftriaxone, clarithromycin, and metronidazole versus the current standard of care of a seven-day course of ampicillin/amoxicillin and azithromycin or erythromycin to prolong pregnancy and decrease adverse perinatal outcomes among hospitalized pregnant individuals undergoing expectant management of PPROM \<34 weeks.

Preterm prelabor rupture of membranes (PPROM) is the most common identifiable risk factor associated with preterm birth and affects 1 in 3 pregnant individuals in the United States with spontaneous preterm birth. Individuals diagnosed with PPROM who meet criteria for expectant management are currently admitted to the hospital for observation until delivery, which is generally recommended at 34 weeks' gestation unless indicated sooner. Initially upon admission, a course of prophylactic antibiotics is administered as this has been shown to prolong pregnancy and improve neonatal outcomes. The standard antibiotic regimen, primarily based on data published in 1997, includes ampicillin followed by amoxicillin with erythromycin or azithromycin for a total of 7 days. Ongoing studies are needed to determine the optimal prophylactic antibiotic regimen given changes in bacterial sensitivities over time, lack of adequate coverage for common organisms including genital mycoplasma, inadequate placental transfer of currently used antibiotic agents, ineffective antibiotic response at reducing the fetal inflammatory response, and new promising antibiotic agents that address these limitations. A promising expanded-spectrum alternative regimen with proof-of-concept is ceftriaxone, clarithromycin, and metronidazole. Observational studies have shown successful eradication of intraamniotic inflammation/infection using this new regimen. This regimen offers multiple potential advantages, including: higher bioavailability, higher transplacental transfer, and effectiveness against genital mycoplasma (clarithromycin), greater anaerobic coverage (metronidazole), and a longer half-life and expanded coverage against gram-negative bacteria (ceftriaxone) compared with the current standard regimen.

Eligibility Criteria:
Inclusion criteria

* Admitted to the inpatient unit for expectant management of PPROM until delivery
* Age ≥ 18 years with the ability to provide informed consent
* Gestational age between 23 0/7 and 32 6/7 weeks

Exclusion criteria

* Having received more than one dose of any prophylactic antibiotic
* Suspected or confirmed infection requiring treatment with antibiotics
* Allergy or contraindication to an antibiotic in either arm
* Maternal immunosuppression
A Clinical Study to Assess the Effect of Novel Glycans on Nitrogen Metabolism of the Gut in Healthy Subjects

This exploratory, randomized, double-blind, placebo-controlled study aims to explore the effect of novel glycans on nitrogen metabolism in the gut in healthy subjects using a stable isotope.


Eligibility Criteria:
To be eligible for inclusion, the patient must fulfill all of the following criteria at screening:

* Willing to provide multiple stool samples
* Be male or female, ≥18 and \<50 years of age
* Have a body mass index ≥18 and \<50 kg/m2
* No current renal, hepatic or metabolic disease, significant dyslipidemia, or infection
* Willing to adhere to dietary requirements as stated in the protocol
* Willing to continue usual exercise routine
* Willing to continue taking any current supplements and vitamins (with the exception of prebiotic or probiotic supplements) that the subject is currently taking, for the duration of the study

Patients will be excluded from the study if they meet any of the following criteria at screening :

* Currently taking probiotic or prebiotic dietary supplements, or have taken them in the past 28 days (prior to Screening Visit), or unwilling to avoid prebiotic or probiotic dietary supplements for the duration of the study
* Currently taking, or have taken during the last seven days prior to enrollment, drugs or other compounds that modulate GI motility
* Currently taking bismuth, or have taken bismuth within seven days prior to enrollment
* Recent history (within six weeks of Screening Visit) of the following condition requiring medical attention or treatment, including over-the-counter medications: constipation, diarrhea, and/or acute GI illness.
* Systemic antibiotics taken within the previous three months (prior to Screening Visit).
* History of or active inflammatory bowel disease
* History of or active irritable bowel syndrome
* History of or active autoimmune disease.
* History of or active GI malignancy.
* Established pre-diabetic status (eg, multiple fasting blood glucose measurements 100 to 125 mg/dL inclusive, or history of failed glucose tolerance tests) and as assessed by HbA1c test.
The Outcome of the Transobturator Tape (TOT) Procedure

The aim of our study is to report the subjective and objective outcome of outside-in transobturator technique (TOT) (Monarc®) in long-term follow-up.

This is a follow-up study concerning 191 patients operated on in Turku University Hospital between May 2003 and December 2004 by using TOT. SUI was diagnosed with a positive stress test, the Urinary Incontinence Severity Score (UISS) and the Detrusor Instability Score (DIS). After a mean of 6.5 years evaluation included a gynecological examination and a supine stress test. Subjective outcome was evaluated with UISS, DIS, a visual analogue scale (VAS), a questionnaire of subjective evaluation of continence, EuroQoL-5D, EQ-5D VAS and short versions of IIQ-7 and UDI-6. Objective cure was defined as negative stress test and an absence of reoperation for SUI during the follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* 191 patients operated on with the TOT procedure between May 2003 and December 2004 at the Department of Obstetrics and Gynecology in the Turku University Hospital.

Exclusion Criteria:
A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer

In this study, researchers want to learn about the safety of a new drug, BAY 3547926, and how well the drug works in people with a type of liver cancer called advanced hepatocellular carcinoma (HCC). Researchers want to find the best dose of BAY 3547926 for people with advanced HCC and look at the way the body absorbs and distributes the drug.

The study drug, BAY 3547926, delivers a radioactive agent to cancer cells. The radioactive agent emits radiations which can damage the cancer cells and cause them to die. These radiations travel a small distance, so are expected to cause little damage to surrounding healthy tissues. This is the first study of BAY 3547926 in humans.

Participants will take part in one of the 3 different parts of the study. In Part 1, participants will receive different doses of BAY 3547926 alone to find the dose that is deemed safe and works best for the participants. When this dose has been found, a larger number of participants will receive BAY 3547926 alone in Part 2 or with other treatments in Part 3 of the study.

During the study, the doctors and their study team will do health check-ups, take pictures (scans) of the body, collect blood and urine samples, and ask participants questions about how they are feeling and what health problems they are having.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic and/or unresectable HCC (hepatocellular carcinoma) with histological or cytological confirmation, or non-invasive diagnosis as per American Association for the Study of Liver Diseases (AASLD) criteria in participants with a confirmed diagnosis of cirrhosis.
* Demonstrated molecular disposition by immunohistochemistry (IHC) on tumor sample.
* Disease not amenable to, or progressive disease after, curative surgery and/or locoregional therapies of established efficacy such as resection, local ablation, chemoembolization.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
* At least one measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. as assessed by local site Investigator within 28 days prior to the start of the study treatment.
* Adequate bone marrow and organ function

Exclusion Criteria:

* Fibrolamellar HCC, sarcomatoid HCC, and mixed hepatocellular/cholangiocarcinoma subtypes.
* Participants with a history or clinical evidence of CNS metastases, unless they meet specific criteria
* History of encephalopathy ≥ Grade 2 within the past 12 months
* Clinically significant ascites
Impact on Quality of Life by Moxibustion in Chemotherapy for Cancer

Most cancer patients experience multiple symptoms related to chemotherapy and use CAM (complementary and alternative medicine) as an adjunct to conventional treatment. Moxibustion is traditional Korean medical therapeutic method and uses the heat generated by burning herbal preparations containing Artemisia vulgaris to stimulated acupoint.

Herein, the investigators propose an open-label pilot study investigating the effectiveness of moxibustion stimulation at abdominal acupoint on quality of life in cancer patients under chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic histopathology of cancer
* Performance status of 0-2 on the European Cooperative Oncology Group (ECOG) performance scale.
* Patients on chemotherapy currently have plan to receive chemotherapy for more than 6 weeks.
* Follow-up possible during the clinical trial
* Informed signed consent

Exclusion Criteria:

* Patients with Severe Heart disease and hypertension that is not controlled (systolic blood pressure \>160 or Diastolic blood pressure \>100)
* Patients with diabetes that is not controlled (FBST \>180 or BST\>250)
* Patients with abdominal injury or severe ascites can't be received moxibustion therapy on abdomen.
* Hypersensitive section to moxibustion treatment
* Inability to comprehend or express oneself in the Korean language
* An Individual deemed to be ineligible by a physician
* Refusal to participate in this trial or to provide informed consent.
Prevalence of Falls and Associated Factors in Haemodialysis Patients

In France, falls among the elderly lead to more than 100,000 hospitalisations and more than 10,000 deaths each year. A French study published in October 2020 highlighted 5 profiles of older people who fall. However, this study is only based on falls of people over 65 years of age that required hospitalisation.

In haemodialysis patients, several studies have shown that the incidence of falls ranges from 1.18 to 1.6 falls/patient/year. This population is more likely to be frail, suffer from sarcopenia, have reduced functional capacity and be polymedicated, all of which are associated with an increased risk of falls. Few studies have focused on falls in young patients. In one American study, where the population was predominantly African American (about 62%), 28.4% of patients had at least one fall during follow-up. The number of falls in people aged 45-64 years was similar to that in people aged over 75 years.

In clinical practice, few patients report the occurrence of falls other than those leading to an emergency department visit or hospitalisation, and these falls are even less likely to be recorded in the medical record.

To our knowledge, there are few or no data on falls in haemodialysis patients of all ages in a French population. This lack of knowledge is partly due to an underestimation of the problem associated with under-reporting.

A study of the prevalence of falls in a haemodialysis population of all ages is therefore necessary to determine whether there is an interest in implementing a collective and/or individual prevention programme, possibly depending on the identified risk factors for falls.

The main objective is to describe the prevalence of falls in chronic hemodialysis patients of all ages.

The secondary objective is to study factors associated with the occurrence of falls in chronic hemodialysis patients of all ages

Eligibility Criteria:
Inclusion Criteria:

* aged more than 18
* hemodialysis for more than 3 months,
* Who live at home,
* Who speak and understand French
* Who agree to participate in the study.

Exclusion Criteria:

* aged less than 18
* Living in an institution,
* Who are protected by law (guardianship, curatorship, safeguard of justice),
* Who do not speak and/or understand French
* Who have cognitive problems that prevent them from understanding the specific questions for the study.
* People permanently bedridden
Clinical Study of IBI362 in Healthy Chinese Male Subjects

This is a study to evaluate the pharmacokinetic characteristics and safety of IBI362 lyophilized powder and IBI362 liquid formulation in healthy Chinese male subjects.

Pharmacokinetic；Safety

Eligibility Criteria:
Inclusion Criteria:

1. 20 years old≤ Healthy males≤45 years old
2. 19 kilograms per meter squared (kg/m²)≤Body Mass Index≤26 kg/m²
3. Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff

Exclusion Criteria:

1. Subjects who have previously completed or discontinued from this study, or who have used IBI362.
2. Abnormal vital signs and physical examination during the screening period;
3. Having cardiovascular, respiratory, liver, kidney, digestive, endocrine, hematologic, neurological, or muscle degenerative diseases can significantly affect drug absorption, metabolism, or elimination, or participation in the study increases risk or interferes with data interpretation.
4. Have a previous or current mental illness.
5. A family history of medullary thyroid carcinoma or multiple endocrine tumor syndrome type 2.
6. There are other factors judged by the investigators that are not suitable for inclusion in this study.