cyrilzakka/clinical-trials huggingface dataset:
Nephrological Outcome and Associated Congenital Anomalies in Pediatric Patients with Horseshoe Kidney

A retrospective, observational multicentre trial on the nephrological outcome and associated congenital anomalies in children with Horseshoe Kidney.

Congenital abnormalities of the kidney and urinary tract (CAKUT) represent the main cause of CKD in children. Among them, the horseshoe kidney (HSK) represents one of the most frequent and is characterised by the presence of two distinct, functioning kidneys positioned on each side of the spine, fused together at one of the poles. The incidence of this condition is approximately 1 case every 400-600 new births with a prevalence in the male sex with a ratio of 2:1. Even though these children aregenerally asymptomatic and the diagnosis is often incidental , some may develop symptoms due to complications, such as infections, nephrolithiasis and urinary tract obstruction. More rarely risks of neoplastic degeneration and renal damage are described following trauma to the abdomen and lumbosacral spine. This condition is also associated in up to a third of cases with other abnormalities: the most frequent affect the urinary tract and genitals; however, abnormalities affecting other organs or systems as well as well-defined syndromic pictures. Due to its frequent asymptomatic nature, horseshoe kidney is historically considered a condition with a good prognosis and rarely as a risk factor capable of reducing survival or predisposing the kidney to long-term damage.

The primary objective of the study is:

To assess the 'nephrological outcome' understood as 'prevalence of patients who developed' and 'survival time free from": chronic renal failure, proteinuria, hypertension nephrolithiasis, UTI, renal neoplasms and renal trauma.

The secondary objectives of the study are:

1. Prevalence of congenital and associated genito-urinary and systemic abnormalities;
2. Description of renal anatomical features;
3. Assessment of the usefulness of second level radiological investigations (VCUG, static renal scintigraphy, ddynamic renal scintigraphy).

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed ultrasound and/or scintigraphic diagnosis of horseshoe kidney;
* Patients with an age at first assessment of between 0 and 18 years;
* Obtaining written Informed consent.

Exclusion Criteria:

* Patients with a definitive diagnosis of another form of CAKUT during the diagnostic pathway.
ME-344 Given in Combination With Hycamtin® in Patients With Solid Tumors

The purpose of this study is to determine the safety and tolerability of ME-344 when given in combination with Hycamtin® in patients with solid tumors


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic confirmed locally advanced or metastatic small cell lung cancer, ovarian cancer, or cervical cancer (Part 1); small cell lung cancer and ovarian cancer (Part 2)
* Patients with ovarian and small cell lung cancer must have failed initial therapy
* Patients with carcinoma of the cervix must have advanced disease not amenable to curative surgery and/or radiation therapy
* Patients may not have received more than 4 prior regimens of therapy
* Patients may not previously have received irinotecan, topotecan or other topoisomerase I inhibitor
* ECOG Performance status 0-1 (Appendix B)
* A minimum life expectancy of 12 weeks
* Adequate bone marrow, hepatic and renal function as evidenced by:

  * Absolute neutrophil count (ANC) \> 1.5 x 109/L
  * Platelet count \> 100 x 109/L
  * Hemoglobin \> 9.0 g/dL
  * Serum bilirubin \< 1.5 x ULN
  * AST/ALT (SGOT/SGPT) \< 2.5 x ULN for the reference laboratory or \< 5 x --ULN in the presence of liver metastases
  * Serum creatinine \< 1.5 x ULN or creatinine clearance ≥ 60 mL/min as measured by institutional standards
* At least 21 days must have elapsed prior to Day 1 Cycle 1, since any radiotherapy, immunotherapy or following major surgery; any surgical incision should be completely healed. At least 14 days must have elapsed prior to Day 1 Cycle 1 since "limited palliative radiotherapy", defined as a course of therapy encompassing \<25% total bone marrow volume and not exceeding 30 GY.

Exclusion Criteria:

* Patients with tumor involvement of the Central Nervous System (CNS). SCLC patients with previously treated CNS lesions must have stable CNS disease for at least 4 weeks
* Patients with uncontrolled infection or systemic disease
* Patients with clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease e.g. angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months
* Patients who have toxicity from last prior therapy that has not recovered to at least Grade 1, with the exception of Grade 2 alopecia
* Patients who have had any chemotherapy regimens, biologic, or targeted therapies within the 2 weeks prior to Cycle 1 Day 1
* Patients with any neuropathy \> Grade 1
* Patients with known hypersensitivity to any components of ME-344 or topotecan study drug product
* Patients with known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both)
* Patients with a history of solid organ transplantation
* Patients with presence of concurrent or active malignant disease (other than disease under study) within the last 12 months with the exception of adequately treated in-situ carcinomas, basal or squamous cell carcinoma, or non-melanomatous skin cancer.

Patients with any psychiatric disorder or social or geographic situation that would preclude study participation
ACTengine® IMA203 Combined With mRNA-4203

This purpose of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA203 in combination with different doses of mRNA-4203. The trial includes participants with previously treated unresectable or metastatic cutaneous melanoma (CM) or synovial sarcoma (SS).

This clinical trial is a multi-center, open-label, non-comparative Phase 1 a/b trial to assess the safety, tolerability, and anti-tumor activity of the combination of IMA203 and mRNA-4203 in HLA-A\*02:01 positive patients with previously treated, unresectable or metastatic cutaneous melanoma (CM) and synovial sarcoma (SS).

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed and documented cutaneous melanoma (CM) or synovial sarcoma (SS) with unresectable or metastatic disease
* HLA-A\*02:01 positive
* Adequate selected organ function per protocol
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
* Life expectancy more than 5 months
* CM participants who must have disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor
* SS participants must have received (or declined) at least one line of treatment (including SoC) and are still in need of further systemic therapy.
* Female participants of childbearing potential must use adequate contraception prior to trial entry until 12 months after the infusion of IMA203 and 15 days after the last mRNA 4203 dose administration

Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years
* Pregnant or breastfeeding
* Serious autoimmune disease
* History of cardiac conditions as per protocol
* Prior allogenic stem cell transplantation or solid organ transplantation
* Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
* History of hypersensitivity to cyclophosphamide, fludarabine, or IL-2
* History of hypersensitivity to mRNA-based medicines
* Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection
* Any condition contraindicating leukapheresis
* Participants with lactate dehydrogenase (LDH) greater than threshold allowed per protocol
* Participants with active brain metastases prior to lymphodepletion
* Concurrent treatment in another clinical trial or a device trial that could interfere with the IMA203 treatment
* Participants with renal impairment AND reduced bone marrow reserve per protocol

Other protocol defined exclusion criteria could apply
INFINITY™ With ADAPTIS™ Technology Study

INFINITY™ with ADAPTIS™ Technology Total Ankle Replacement Follow-up (ITAR2) - Prospective, multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ Total Ankle System Number of Subjects 200 patients with up to 13 sites

The selected design is a multi-center, non-randomized, prospective study of 200 subjects in the US with up to 13 investigational sites and a potential for more as needed to meet the enrollment requirements. The study subjects included are those with ankle joints damaged by severe rheumatoid arthritis, post-traumatic disease, and degenerative arthritis and implanted with the INFINITY™ With ADAPTIS™ Technology Total Ankle System.

Eligibility Criteria:
Inclusion Criteria:

* Be over 22 years of age at the time of surgery;
* Diagnosed with unilateral and/or bilateral ankle joint disease;
* Diagnosed with ankle joint damage from rheumatoid arthritis, post-traumatic, or degenerative arthritis;
* Willing and able to consent to participate (written, informed consent;
* Willing and able to attend the requested follow-up visits;
* A clinical decision has been made to use INFINITY™ with ADAPTIS™ Technology Total Ankle System replacement prior to enrollment.

Exclusion Criteria:

* Subjects with an ankle condition, as determined by the investigator, to be an inappropriate candidate for a total ankle replacement;
* Subjects requiring revision total ankle replacement of the ankle being considered for study
Multi-electrode Radiofrequency Renal Denervation System Feasibility Study

This is a prospective, single-arm, non-randomized and open label feasibility study. The study is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal denervation in patients with uncontrolled hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Individual is ≥ 18 and ≤ 80 years old.
* Individual has an office systolic blood pressure of 160 mmHG or greater (≥ 150 mmHg for Type 2 diabetics) based on an average of 3 office/clinic blood pressure readings
* Individual is adhering to a stable medication regimen including ≥ 3 anti-hypertensive medications(preferred that one is a diuretic) for a minimum of two weeks prior to screening.

Exclusion Criteria:

* Individual has an estimated glomerular filtration rate (eGFR) of \< 45 mL/min/1.73 m2
* Individual has type 1 diabetes mellitus
* Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
* Individual has primary pulmonary hypertension.
* Individual is pregnant, nursing or planning to be pregnant.
Study to Assess the Safety, Tolerability, and Pharmacokinetics of REGN5381 (an NPR1 Agonist) in Adult Humans

The primary objective of the study is to evaluate the safety and tolerability of single intravenous (IV) doses of REGN5381 in healthy normotensive and otherwise healthy hypertensive adults.

The secondary objectives of the study are:

* To evaluate the effect of single IV doses of REGN5381 on blood pressure (BP) and heart rate (HR) in healthy normotensive and otherwise healthy hypertensive adults
* To evaluate the effect of single IV doses of REGN5381 on cardiac stroke volume (SV)
* To evaluate the pharmacokinetics (PK) of single IV doses of REGN5381
* To evaluate the immunogenicity of single IV doses of REGN5381


Eligibility Criteria:
Inclusion Criteria:

1. Normal or mildly elevated blood pressure as defined in the protocol

Exclusion Criteria:

1. History of cardiovascular disease as defined in the protocol
2. Protocol-defined risk factors for cardiovascular disease
3. History of unexplained syncope, autonomic dysfunction, or neurologic disease.

NOTE: Additional Inclusion / Exclusion criteria apply
Pilot Feasibility Trial of HEALthy Beginnings for Middle-Aged, and Older Homeless Women

This is a mixed methods pilot feasibility trial of HEALthy Beginnings, an innovative, nurse-driven intervention. Middle-aged and older, homeless women (MAO-HW) will participate in the HEALthy Beginnings intervention and select MAO-HW will be invited to participate in post-intervention qualitative focus groups to evaluate the program.

This pilot feasibility trial will enroll middle-aged and older, homeless women (MAO-HW) in the HEALthy Beginnings intervention. Participants will be asked to complete a baseline questionnaire and locator guide. Participants will then engage over a period of approximately three months in nine 60-90 minute group sessions focused on health topics, and to meet with a research team member for six private sessions which will last up to 45 minutes each to assess the program and discuss content.

Fifteen participants will be asked to return at completion of the group/individual sessions to participate in a post-intervention qualitative focus group and follow-up questionnaire to evaluate the HEALthy Beginnings intervention.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported age 40 years or older
* Sex assigned Female at birth
* Homeless, or living in a shelter designed to provide transitional housing
* Self-reported multimorbidity (at least 2 physical/mental health conditions)
* Able to communicate in English

Exclusion Criteria:

* Experiencing hallucinations
* Exhibiting signs of acute intoxication (e.g., slurred speech, pin-point pupils, difficulty walking)
* Non-English speaking
* Unable to understand study procedures (e.g., screening questions)
AXIOS Lumen Apposing Metal Stent for Walled Off Necrosis Drainage IDE Study

To demonstrate safety and effectiveness of lumen-apposing metal stents for resolution of walled off pancreatic necrosis (WONs) in patients with WONs with solid component \>30%.

This study is a prospective, single arm, multi-center trial. Treatment of up to 40 patients will take place at up to 6 clinical centers. Patients who meet all eligibility criteria will receive the AXIOS stent for up to 60 days stent indwell and 6 months follow-up after stent removal.

Eligibility Criteria:
Inclusion Criteria:

* Age between 22 and 75 years old
* Severe or moderately severe acute necrotizing pancreatitis, defined per the 2012 Revised Atlanta Classification.
* WON resulting from necrotizing pancreatitis per contrast-enhanced CT with the following characteristics, per the 2012 Revised Atlanta Classification:

  * Heterogeneous with liquid and non-liquid density with varying degrees of loculations (some may appear homogeneous)
  * Well defined wall
  * Location-intrapancreatic and/or extrapancreatic
* Infected WON or symptomatic sterile WON Note: WON-related symptoms may include: pain, fever, leukocytosis, failure to thrive or deterioration of overall heath score, gastric outlet obstruction (GOO), weight loss, biliary obstructive symptoms, systemic inflammatory response syndrome (SIRS), deteriorating organ function, chronic nausea, lethargy, and inability to eat or gain weight
* Imaging suggestive of greater than 30% necrotic material
* WON ≥ 6cm in size
* Eligible for endoscopic intervention
* Acceptable candidate for endoscopic transluminal drainage
* Patient understands the study requirements and the treatment procedures and provides written Informed Consent
* Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post imaging study

Exclusion Criteria:

* Pseudocyst
* Cystic neoplasm
* Untreated Pseudoaneurysm \> 1cm within the WON
* More than one WON clearly separated and requiring drainage
* WONs that require dual modality interventions (endoscopic and percutaneous) from the beginning (i.e. deep paracolic space involvement that is inaccessible through the central drainage access)
* Prior surgical, interventional radiology or endoscopic procedures for the treatment of the WON
* Abnormal coagulation:

  * INR \> 1.5 and not correctable
  * presence of a bleeding disorder
  * platelets \< 50,000/mm3
* Intervening gastric varices or unavoidable blood vessels within the access tract (visible using endoscopy or endoscopic ultrasound)
* WON that poorly approximates the GI lumen (≥1cm away)
* Pericolic gutter necrosis
* Pelvic necrosis
* Prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient
* Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study
* Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study
Effects of Anesthetics and Surgery on Sleep Quality in Patients Undergoing Posterior Spinal Instrumentation Surgery

Investigators aimed to evaluate the impact of the anesthesia method and surgical procedure on the sleep patterns and sleep quality of patients undergoing posterior spinal instrumentation using the Pittsburgh Insomnia Rating Scale-20 (PIRS-20).

A total of 40 participants ASA (American Society of Anesthesiology) I-III aged 18 and over who underwent elective spinal posterior instrumentation was included. The participants were divided into two groups randomly - those with sevoflurane and remifentanil anesthesia and those with total intravenous anesthesia (TIVA) - using the closed envelope method. Participants were evaluated before and after the surgery with the PIRS-20 (surgery one month previously and postoperative 7th day) for sleep quality, VAS (Visual Analogue Scale; recorded preoperative night and postoperative first hour), pain, and State-Trait Anxiety Inventory (STAI) for anxiety (recorded preoperative night and postoperative 7th day) scores.

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiology) I-III
* Aged 18 and over
* Who underwent elective spinal posterior instrumentation

Exclusion Criteria:

* Aged 17 and under
* ASA (American Society of Anesthesiology) IV
* Presence of psychological illness
* Presence of psychological illness
* Presence of sleep disorder
Low-dose GH Supplementation Increases Clinical Pregnancy Rate

The objective of this study is to assess whether a low dose of GH supplementation (0.5 IU/day) increases clinical pregnancy rates in women with a history of POR who failed to become pregnant in two previous IVF cycles.

The investigators aim to study the impact of a low-dose growth hormone (GH) supplementation in pregnancy rates in poor responders in a prospective, self-controlled study of 64 poor responders to previous IVF cycles who failed to achieve pregnancy and were supplemented with low-doses of GH in a subsequent cycle using the same gonadotropin dose and protocol. Our primary endpoint was the clinical pregnancy rate (CPR), considering secondary endpoints the number of retrieved oocytes, embryos, embryo quality and the proportion of cycles with embryo transfer.

Controlled ovarian hyperstimulation will be performed using a GnRH agonist long protocol from day 21-23 of the menstrual cycle at a dose of 1 mg/ day, using the same schedule and dose as in the previous cycle, so that the only difference between them is the GH supplementation.

After confirming pituitary inhibition, the dose of GnRH agonist will be decreased to 0.5 mg/day, and COH will begin with gonadotropins at a dose of 300 UI, subsequently adjusting according to clinical response. Human chorionic gonadotropin (hCG) will be administered when follicles reached \> 17 mm in diameter. A dose of 0.5 IU of GH will be administered daily from the first day of the agonist until the day of hCG administration. Oocyte retrieval will be performed 36 hours after hCG administration by ultrasound-guided follicle aspiration.

Eligibility Criteria:
Inclusion Criteria:

* Women with a history of POR, defined according to the Bologna criteria
* Absence of pregnancy in at least two previous IVF cycles

Exclusion Criteria:

* Body mass index ≥ 30 kg/m2
* Presence of endocrinopathies
* Altered karyotype in one or both partners
* History of invasive ovarian surgery
* History of chronic, autoimmune or metabolic diseases
* Altered meiosis in testicular biopsy or altered sperm-FISH
* Drug therapy in the male partner
* Participation, within the previous 6 months, in another clinical trial with medication
Change of QRS Morphology and Electrophysiological Characteristics During Pacing Within the Interventricular Septum

Conduction system pacing (CSP), including His bundle pacing (HBP) and left bundle branch (LBB) pacing (LBBP), as a physiological pacing strategy, can achieve interventricular and/or intra-left ventricular mechanical synchronization by delivering physiological or nearly physiological ventricular activation. And many studies have verifed clinical efficacy of CSP that it can significantly relieve dyssynchrony of ventricular contraction, improve cardiac function and reduce the risk of heart failure as compared to right ventricular pacing. However, CSP has some shortcomings which limit its widespread application to some extent. As for HBP, although it can achieve optimal physiological ventricular synchronization, the problems of relatively high pacing threshold, low R-wave amplitude, the long-term performance, and inability to correct infra-Hisian atrioventricular block and intraventricular block in some patients have always been concerns. Nevertheless, LBBP is likely free of the restrictions mentioned above. On the contrary, LBBP can capture the left conduction system by directly stimulating the proximal LBB distal to the site of conduction block, thereby achieving rapid and physiological LV activation with a lower and stable pacing threshold and higher R-wave amplitude. However, as a newly emerged physiologic pacing technology, LBBP is currently in the exploratory stage and there are some phenomena to be interpreted, such as the evolution of pacing QRS morphology during the lead penetration into the interventricular septum. Therefore, the aim of this study is to assess the morphological evolution and electrophysiological characteristics of various pacing QRS patterns observed as the lead penetrates the interventricular septum from right to left.


Eligibility Criteria:
Inclusion Criteria:

* The indications for pacemaker implantation are in accordance with the 2021 European Society of Cardiology (ESC) guidelines.
* Patients requiring a high percentage of ventricular pacing (\>40% expected ventricular pacing) include patients with advanced or third-degree atrioventricular block and atrial fibrillation with bradycardia.
* Left bundle branch pacing will be performed.
* Patients voluntarily participate and sign informed consent.

Exclusion Criteria:

* Atrioventricular block caused by reversible factors such as acute myocardial infarction and electrolyte disturbance.
* Patients with severe liver or renal failure.
* Life expectancy \< 1 year.
* Patients with age \< 18 years.
* Left ventricular ejection fraction (LVEF) \< 40%.