cyrilzakka/clinical-trials huggingface dataset:
Follow up After Cryoablation of Small Renal Masses.

Currently there is no consensus on post procedural follow up imaging following percutaneous cryoablation of renal tumors. Interpretation of conventional contrast enhanced imaging (CT and MRI) during follow up can be very challenging. The objective of this study is to evaluate the feasibility of early evaluation of the therapeutic effect by performing early follow up imaging after percutaneous MR-guided cryoablation of pT1a renal cell carcinoma using 111In-Girentuximab-DOTA SPECT CT imaging.

With the growing number of small renal masses (SRMs) detected, a growing interest in minimal invasive treatment options for these lesions is seen as they come with several advantages compared to partial nephrectomy. Current guidelines state that patients with a small renal mass unfit to undergo surgery, should be considered for minimal invasive ablative treatment. Although percutaneous cryoablation is shown to be a safe and effective therapy for SRM, there is no consensus on post procedural follow up imaging which should be aimed at evaluation of therapeutic effect of the intervention and the early detection of residual and recurrent disease. Also interpretation of conventional contrast enhanced imaging (CT and MRI) during follow up can be very challenging due to contrast enhancement not necessarily indicating residual or recurrent disease.

The objective of this study is to evaluate the feasibility of early evaluation of the therapeutic effect by performing early follow up imaging after percutaneous MR-guided cryoablation of pT1a renal cell carcinoma 111In-Girentuximab-DOTA SPECT CT imaging.

Therefore, before cryoablation, a targeting 111In-Girentuximab-DOTA SPECT CT scan is performed. Additional functional 111In-Girentuximab-DOTA SPECT CT scan 4-6 weeks after percutaneous MR-guided cryoablation of small renal masses is performed. The latter will take place in case of proven targeting on the pre procedural 111In-Girentuximab-DOTA SPECT CT scan. Standard 1 and 3 months follow up MRI after treatment is performed.

Eligibility Criteria:
Inclusion Criteria:

* \>50 years of age;
* At least one untreated T1a tumour of one kidney (tumour ≤ 4 cm in greatest dimension);
* Signed IRB-approved informed consent form.

Exclusion Criteria:

* Pregnancy or breast feeding;
* Known hypersensitivity or HACA against Girentuximab.
* Administration of experimental medication for imaging purposes within three months before administration of Indium-111-Girentuximab for this study, except the administration of Girentuximab labeled with a random isotope.
The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on the Immune Function for Cirrhosis Patients

In this study, the investigators compared the improvement of immune function related indicators in patients with liver cirrhosis after laparoscopic splenectomy and azygoportal disconnection. To determine whether surgical treatment can help enhance postoperative immune function and improve patient prognosis.

The patients were enrolled according to the research criteria, and collected the general basic information of the patients. After the preoperative preparation was perfected, the same surgical team performed laparoscopic splenectomy and azygoportal disconnection, and the same nursing team performed the nursing after the operation. Then, patients received a unified treatment plan after surgery, including medication, other treatments and follow-up. During the treatment, the immune function related indicators of the patients were monitored before surgery, 3, 6, 12 and 24 months after surgery, including the counts of leukocytes, neutrophils, lymphocytes, and monocytes, and the levels of CD4+,CD8+,CD4+/CD8+, and CD19,CD20.

Eligibility Criteria:
Inclusion Criteria:

* A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
* Splenomegaly with secondary hypersplenism
* gastroesophageal variceal bleeding
* Informed consent to participate in the study

Exclusion Criteria:

* Hepatocellular carcinoma or any other malignancy,
* Child-Pugh grade C
* Recent peptic ulcer disease
* History of Hemorrhagic stroke
* Pregnancy.
* Uncontrolled Hypertension
* Human immunodeficiency virus (HIV) infection
Study Evaluating The Efficacy And Safety Of Xyntha In Children Less Than 6 Years Of Age

This study will be investigating the safety and efficacy of Xyntha (moroctocog alfa (AF-CC)) in male patients less than 6 years old. Annualized bleeding rates and physician / caregiver assessments of responses to treatment will be characterized. FVIII inhibitor levels will be assessed throughout the study.

The study was terminated on 22 Sept 2009 due to competition with another Wyeth study for a similar patient population. The decision to terminate the trial was not based on any safety issues.

Eligibility Criteria:
Inclusion Criteria:

* Male patients less than 6 years of age with moderately severe to severe hemophilia A (FVIII less than or equal to 2%).
* Treatment history of less than 50 exposure days to prior recombinant or plasma-derived FVIII replacement products.
* Not receiving treatment for HIV or hepatitis infection, or the patient is on a stable antiviral regimen at the time of enrollment in the study.

Exclusion Criteria:

* Presence of any bleeding disorder in addition to hemophilia A.
* Inhibitor titer of greater than or equal to 5 Bethesda Units (BU) at screening.
* Treated with immunomodulatory therapy during the screening period
* Treatment history of more than 5 exposure days (ED) to Xyntha.
* Known hypersensitivity to hamster protein.
Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples from Colorectal Cancer Patients

RATIONALE: Studying samples of tissue, blood, urine, stool, and other biological fluids from patients with cancer and from healthy volunteers undergoing colonoscopy or endoscopy may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is looking at gastrointestinal biomarkers in tissue and biological fluid samples from patients and participants undergoing colonoscopy, endoscopy, or surgery.

OBJECTIVES:

* Identify new potential biomarkers of increased gastrointestinal cancer risk using tissue and biofluid samples from patients and volunteers undergoing colonoscopy, endoscopy, or surgery.
* Develop new screening strategies based on substances found in tissue and biofluid samples.

OUTLINE: This is a multicenter study.

Patients and healthy volunteers undergo colonoscopy, endoscopy, or surgery. Patients and healthy volunteers also undergo tissue (e.g., tumor or normal mucosa) and biofluid (e.g., blood, urine, cyst fluids or tumor cells, bile and pancreatic juices, and/or stool) sample collection. Samples are analyzed for tumor markers by proteomic methods and protein analysis. If candidate biomarkers are identified, samples are stored for future studies involving these biomarkers. Information, including demographics, personal and family history of cancer, and prior and current colonoscopy, endoscopy, or surgery results, is collected from the medical record and stored in the project database.

Patients are followed once a year for up to 5 years to determine if biomarkers have a prognostic significance.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Undergoing colonoscopy or endoscopy for diagnostic or screening purposes at the Vanderbilt University Medical Center or at the Veterans Affairs Medical Center AND
* Meets 1 of the following criteria:

  * Diagnosis of gastrointestinal (GI) cancer, polyps, or inflammatory bowel disease
  * History of previously treated GI cancer, polyps, or inflammatory bowel disease

PATIENT CHARACTERISTICS:

* Capable of giving informed consent
* Not mentally or medically impaired
* No bleeding disorder

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid

Purpose: To decrease symptom burden, improve cognitive function, improve endurance, and decrease fatigue in subjects with post-acute sequelae of COVID-19 (PASC) or "long-hauler" COVID using amantadine. If amantadine use is determined to be efficacious in this population, the findings of this study will be used towards a subsequent randomized control trial.

This study is a prospective, open-label, single-blind, randomized control study. Study duration is approximately 6 weeks starting at the baseline visit. We will recruit 30 participants (15 per arm) for this pilot study.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-65
* Can provide informed consent
* Confirmed COVID+ test (either rapid antigen or PCR) between 8 weeks and one year prior to initial visit.
* Able to consent in English
* Endorse symptoms during their initial evaluation and history with the provider that began around the time of the acute COVID19 infection (subjective) including cognitive changes such as cognitive fatigue, brain fog, memory issues,attention issues AND have symptoms in at least 1 out of the 2 following symptom categories:
* Category 1: Decreased endurance, physical fatigue, weakness
* Category 2: Depression, anxiety

Exclusion Criteria:

* Known hypersensitivity to amantadine
* Clinically significant psychiatric, neurologic, renal, hepatic, opthalmologic, cardiac impairment in the opinion of the investigators, including but not limited to:
* Psychiatric:
* Acute or chronic unstable Axis I psychiatric illness
* History of psychosis
* Severe depression Patient Health Questionnaire-9 (PHQ-9) score \>= 20
* Suicidality
* Neurologic:
* Epilepsy
* Cognitive dysfunction predating COVID infection
* History of delirium
* Neurologic conditions with agitation or confusion
Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects

This study will evaluate safety, tolerability, and Pharmacokinetics (PK) of ID119031166M with the Exploration of Pharmacodynamic (PD) effects in Healthy Participants.

This is a Phase 1, randomized, double-blind, placebo-controlled, sequential single/repeated-dose study. This study is a dose-escalation study with healthy participants in single ascending dose (SAD) including food-effect and multiple ascending dose (MAD) cohorts to determine the highest allowable dose (HAD).

Eligibility Criteria:
Inclusion Criteria:

* Must be Caucasian (White American of European or Latin American descent).
* Healthy participants of Japanese origin are allowed up to 50% in each MAD cohort.
* Body mass index (BMI) within the range of 18.5 to 30 kg/m\^2 (inclusive) at the time of Screening.
* No congenital or chronic diseases that require treatment and without pathologic symptoms or signs on medical examinations.
* Participants with normal renal function.
* Women are eligible to participate if not pregnant, not breastfeeding. Male subjects should be willing to use 'highly effective' or 'applicable' contraceptive methods.

Exclusion Criteria:

* Currently have an acute disease with active symptoms.
* History of melanoma or other skin issues (including, but not limited to pre-cancerous areas, atopic dermatitis, psoriasis, rosacea, excessive moles etc.).
* History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, musculoskeletal, or cardiovascular disease and/or arrhythmias.
* History of clinically significant hypersensitivity reaction to any drugs or additives.
* History of any gastrointestinal disease.
* History of substance use disorder including history of drug abuse disorder or history of alcohol use disorder, or tobacco use disorder or excessive caffeine intake.
* Evidence of moderate or excessive alcohol consumption.
* Tested positive in viral serology tests (hepatitis B virus \[HBV\], hepatitis C virus \[HCV\], and human immunodeficiency virus \[HIV\]).
* Known family history or known presence of long QT syndrome.
* A history of hypokalemia.
* Use of concomitant medicines that prolong QT/QTc (QT Interval Corrected for Heart Rate).
* History of active viral hepatitis (hepatitis A, B, C, and E), or autoimmune hepatitis.
* History of Multiple Endocrine Neoplasia type 2.
* Solid organ transplantation, except corneal transplants.
* History or presence of neutropenia which is defined as absolute neutrophil count (ANC) \< 1.5 at Screening and admission.
* Participants with a microalbuminuria.
* Hemoglobin levels below 12.0 g/dL at Screening or Baseline.
* White Blood Cell levels below 3.5 × 109/L at Screening or Baseline.
* Platelet count \< 150,000/µL, international normalized ratio (INR) \> 1.5, albumin \< 3.5 g/dL
The Effect of Intravenous Magnesium Sulfate on Intraocular Pressure Following Tracheal Intubation

The aim of this study is to assess the effect of preoperatively administered intra venous magnesium sulfate in attenuating pressure response to laryngoscopy and endotracheal intubation in adult patients scheduled for elective non ocular surgery


Eligibility Criteria:
Inclusion Criteria:

* 18 to 38 years old
* ASA I
* scheduled for elective ENT ambulatory surgeries under general anesthesia

Exclusion Criteria:

* specific major hepatic, renal and cardio-vascular disease
* known to have allergic reaction to magnesium sulphate or other drugs , -hypermagnesemia
* hypocalcemia
* anuria
* heart block
* pregnancy
* any degree of renal insufficiency
* digitalised patients
* positive history of glaucoma or intra ocular hypertension
* refused to participate
RELIEF Study: Real-world Evaluation of LUTS Interventions and Patient Experience During Follow-up

The objective of the RELIEF Study is to compare the safety, effectiveness and patient experience outcomes in real-world subjects treated with different modalities for symptomatic BPH.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of symptomatic BPH

Exclusion Criteria:

* Prior surgical intervention for treatment of BPH
* Unable or unwilling to give informed consent or unwilling to complete all required questionnaires and follow-up assessments
Identification of Risk Factors Associated With Neoplastic Complications After Renal Transplantation in Nord-Pas de Calais , Normandy and Picardy Regions

Kidney transplantation is now the treatment of choice for end-stage renal disease (ESRD). Between 2800 and 3000 kidney transplants are performed each year in France and more than 33 000 patients are living with a functioning graft.

Preventing allograft rejection requires the use of immunosuppressive therapy, the intensity decreases as the distance from the day of transplantation. Unfortunately, treatment favors certain complications, including infectious and neoplastic. These represent a major cause of mortality in these patients. If the frequency of skin cancer is greatly increased in this population, that of solid tumors remains a concern. Approximately 20% of patients develop cancer after 10 years of graft , half non- skin cancers, the main risk factor is immunosuppressive therapy .

The aim of the study is to evaluate, in a large population of patients treated in 4 regions ( the Nord-Pas de Calais, the Upper and Lower Normandy and Picardy) risk factors (in particular the nature of the immunosuppressive treatment) of developing a neoplastic complication, skin cancers and solid tumors, after renal transplantation.

A retrospective analysis of the previous 10 years, from 2002 to 2011 will be conducted. This study will better understand the epidemiology of these complications but also allow to identify risk factors associated, including demographic, environmental and related to immunosuppressive therapy.

Thereafter, we hope to implement preventive measures or prospective studies, allowing us to reduce the prevalence of this complication.

Eligibility Criteria:
Inclusion Criteria:

* All adult renal transplant patients in the 4 centers of interregion North - West
* Patients transplanted during the period from 1 January 2002 and 31 December 2011
* Patients recipients of first, second or third renal transplantation
* Patients transplant recipients from a living or deceased donor whatever the immunological risk
* Eligible patients will be included after being informed by their doctor and after accepting their data to be processed in the framework of this study
* Patient with a health insurance coverage

Exclusion Criteria:

* Patients transplanted as child
* Patients transplanted before 1 January 2002
* Patients followed in the interregion but transplanted in another center
* Patients recipients of a double transplant (two kidneys or kidney plus other organ)
* Patients that do not accept their medical data to be included in the database
Bronchoscopic Microwave Intervention Treatment in Advanced Central NSCLC

A randomized, prospective study of the efficacy and safety of the first-line treatment in advanced central non-small cell lung cancer patients by anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy versus anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention

This study is a randomized, prospective study, which will analyze the efficacy and safety of the first-line treatment in advanced central non-small cell lung cancer patients by anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy versus anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention. The efficacy will include objective response rate, disease control rate, progression-free survival, and overall survival. The safety will include adverse events and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* advanced central non-small cell lung cancer patients, untreated, tolerating bronchoscopy

Exclusion Criteria:

* contraindications to tracheoscopy, chemotherapy, and immunotherapy
A Multi-center Clinical Study of Drug Antibody and Precision Transfusion in China

Blood samples for hemolytic anemia in patients treated with one or more of the antibiotics including piperacillin, amoxicillin, cefazolin, cefuroxime, ceftriaxone, cefoxitin sodium, and vancomycin were screened for the production of drug antibodies.

The widespread use of antibiotics and anti-tumor drugs in clinical practice leads to poor efficacy or even toxic side effects and other adverse events, which are often related to the immune response caused by the cells adsorption or binding because of the long-term use of drugs to cause the generation of antibodies or drug decomposition.The immune hemolytic anemia caused by antibiotics is more common.In this study, the remaining blood samples of patients who developed hemolytic anemia using one or more antibiotics including piperacillin, amoxicillin, cefazolin, cefuroxime, ceftriaxone, cefoxitin sodium and vancomycin were preliminarily screened to determine which drugs caused hemolytic anemia.The types of diseases and antibiotics used in patients with drug-induced hemolytic anemia were also analyzed.The positive rate of drug antibody production was calculated and the difference of drug antibody production mechanism was analyzed.The blood samples of the positive patients and some negative patients were collected and preserved to prepare for the follow-up study.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary signing of informed consent;
* No limitation on age or sex;No limitation on nationality;Regional unlimited;
* Participates treated with one or more of the drugs including piperacillin, amoxicillin, cefazolin, cefuroxime, ceftriaxone, cefoxitin sodium, and vancomycin.

Exclusion Criteria:

* High fat blood sample;
* Sample of severe hemolysis;
* Jaundice sample;
* The sample is cloudy and may be contaminated with bacteria;
* The source of the sample is unknown and cannot be traced;
* Patients with a history of medication who were deemed inappropriate to participate in this study were evaluated by the researchers.
Repeat Antenatal Steroids Trial

A course of steroids given to a mother who is in labor with a premature fetus will reduce the risk of the premature infant dying or having serious complications. This trial will test whether more than one course of antenatal steroids is more beneficial or risky to the infant than a single course.

After the NICHD Consensus Development Conference in 1994, the antenatal administration of antenatal corticosteroids (betamethasone or dexamethasone) for prevention of death and the serious morbidities associated with preterm birth has become an accepted standard in American obstetric practice. Studies have shown that maximum beneficial effect occurs when the fetus is delivered within 7 days of antenatal steroid administration. The efficacy and safety of a single course of corticosteroids has been substantiated but it is unknown whether repetitive dosing has similar efficacy or what the maternal, fetal and neonatal risks are. Repeat courses of steroids are often administered. Two popular regimens exist for the patient who remains undelivered more than one week after initial therapy but who remains at risk for preterm birth. In one, steroids are repeated weekly until 34 weeks gestation, while in the other, steroids are only given once.

This multicenter trial is testing the safety and efficacy of weekly administration of antenatal steroids. Twenty four hundred women \< 32.0 weeks gestation who are at risk for spontaneous preterm delivery and remain pregnant at least seven days after an initial course of corticosteroids are being randomized to either weekly courses of masked study drug (betamethasone or placebo) for 4 weeks or delivery, whichever comes first. Patients are asked about side effects at the weekly visits and samples of maternal blood at randomization and delivery are collected. Cord blood and placentas are also collected. Cranial ultrasounds are done on all neonates. On a subgroup of patients, an adrenocorticotrophic hormone (ACTH) stimulation test is being performed and an auditory brainstem response (ABR) performed. All infants attend a follow-up visit at 18 to 22 months corrected age where certified examiners, masked to study group assignment, collect physical and neurological data. The Bayley Scales of Infant Development will also be administered. A subgroup of infants will be seen at 36 months to administer the Intelligence scale from the McCarthy Scales of Children's Abilities.

Eligibility Criteria:
Inclusion criteria:

* Pregnant
* Gestational age \> 23.0 wks and \< 31.6 wks
* Singleton or twin pregnancy
* Intact membranes
* At-risk for spontaneous preterm delivery
* Received full course of corticosteroids within the previous 7 days

Exclusion criteria:

* Diagnosis of fetal lung maturity
* Chorioamnionitis
* Non-reassuring fetal testing
* Known major fetal anomaly
* Corticosteroid therapy, other than qualifying course
* Insulin dependent diabetes
* Active preterm labor at the time of randomization
* Delivery intended outside center
* Participation in any intervention study which influences neonatal morbidity or mortality
* Previous participation in this trial