cyrilzakka/clinical-trials huggingface dataset:
Compression Anastomosis For Low Anterior Resection in Previously Radiated Patients Using the CAR™ 27

The purpose of this study is:

Evaluation of the safety and effectiveness of the Compression Anastomosis Ring (CAR™ 27) device for creation of circular, colorectal anastomoses in previously radiated patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years old.
* Patient is scheduled for a non-emergency TME and low anterior resection (\< 10cm from the anal verge).
* Patient has been radiated to the pelvic area 6-8 weeks prior to the study.
* Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.

Exclusion Criteria:

* Patient has known allergy to nickel.
* Patient undergoing an emergency procedure or has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or inflammatory bowel disease.
* Patients are participating in another clinical trial which may affect this study's outcomes.
* Patient has been taking regular steroid medication.
* Patient has contraindications to general anesthesia.
* Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.
CT/MR-US Automatic Fusion System in Pre-procedure Planning for Radiofrequency Ablation

To prospectively evaluate the technical success rate of real-time computed tomography/CT/magnetic resonance imagingMR and -ultrasound (CT/MRI-US) automatic fusion system and the long-term therapeutic efficacy of radiofrequency ablation (RFA) guided by automatic fusion in hepatocellular carcinoma (HCC) patients.

RFA is one of commonly used local therapies for primary or secondary liver tumors. For successful and safe procedure, safe route of electrode and lesion visibility are essential for RFA, and the conditions are usually evaluated on pre-RFA planning ultrasonography (USG). However, RFA is sometimes aborted due to limited sonic window of various cause and challenging identification of small isoechoic tumors or hepatocellular carcinomas among dysplastic nodules . Therefore, precise targeting and assuring safe route would be of clinical importance. In this preliminary study, investigators attempted to determine automatic US and CT/MR fusion technique would be able to improve RFA feasibility in patients with liver tumors.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic or typical imaging based diagnosis of HCC
* Multiphase CT or MRI within 3 months ahead of procedure
* No evidence of distant metastasis
* No contraindications for conventional RFA procedure in our institute, which are uncontrolled coagulopathy (international standard ratio ≥ 1.6, or platelet \> 50,000), poor cooperation, unfeasible for sedation, portal vein tumor thrombus, tumor number \>4, largest tumor size \> 5cm, and tumors abutting portal vein or bile ducts bigger than segmental branches.

Exclusion Criteria:

* Lack of multiphase CT or MRI withing 3 months ahead of procedure
* RFA planned for palliative purpose
* Diagnosed as non-HCC malignancy
* Right hepatectomy state
Urine Toxicology With Pharmacogenomic Interpretation Assay: UTOPIA

The objective of this study is to evaluate the impact of pharmacogenomic aspects of drug metabolism on the measurement of drug and drug metabolites on urine drug testing (UDT).


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent
* Pharmacogenomic testing within the last 60 days
* Planned UDT

Exclusion Criteria:

* Subject has chronic renal dysfunction, Chronic Kidney Disease Stage 4 or 5
* Subject has a history of abnormal hepatic function within the last 2 years (INR \>1.2 not attributable to anticoagulant medications, AST or ALT \>1.5x normal, or suspected cirrhosis)
* Subject has a history of malabsorption (short gut syndrome);
* Subject has a history of any gastric or small bowel surgery;
* Subject is currently hospitalized;
* Subject is currently receiving intravenous medication.
Safety and Efficacy of BMMNC in Multiple Sclerosis (MS)

The aim of this study is to prove the BMMNC Therapy in Multiple sclerosis, and to control symptoms and help to maintain a normal quality of life of suffering patients.

Multiple sclerosis (MS) is considered to be an autoimmune disease that is caused by the immune system attacking the central nervous system (CNS) leading to myelin loss and axonal damage, resulting in long-term disability. The pathophysiology of MS is complex with involvement of genetic and environmental factors that define the susceptibility to generate the autoimmune attack. MS is caused by damage to the myelin sheath, the protective covering that surrounds nerve cells. When this nerve covering is damaged, nerve signals slow down or stop.The nerve damage is caused by inflammation. Inflammation occurs when the body's own immune cells attack the nervous system. Currently, treatment of MS relays mainly on immunosuppression combined with monoclonal antibodies and steroid therapies.The most advanced application for MSCs in the neurological clinical arena is in multiple sclerosis.This clinical study time period is for 1 year. This study is carried out to see the role of BMMNC cell Therapy in Multiple sclerosis, and to control symptoms and help to maintain a normal quality of life of suffering patients.

Eligibility Criteria:
Inclusion Criteria:

Confirmed Diagnosis of MS, Aged 18 - 65 years. Duration of disease: \>5 years Signed, written informed consent Willing and able to comply with study visits according to protocol for the full study period

Exclusion Criteria:

* Patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results
* Patient with any active or chronic infection
* No life-threatening organ dysfunction.
* Pregnancy or risk of pregnancy.
* Patients who are seropositive for HIV1, HIV2, Hepatitis B Surface Antigen, and Hepatitis C
* Patients unable to give written informed consent in accordance with research ethics board guidelines
* Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization
* Treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization
* Treatment with corticosteroids within the 30 days prior to randomization
* Current treatment with an investigational therapy
Phase 2 RCT of Alvimopan vs. Placebo After CRS/HIPEC

The purpose of this study is to investigate the ability of alvimopan to reduce the time to return of bowel function in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. Half of the participants will receive alvimopan or and half will receive placebo immediately before and for up to seven days after surgery.

Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a surgical procedure to treat cancer that has spread to the lining of the abdominal cavity (peritoneal metastases). It is associated with a prolonged time for return of bowel function after surgery.

Alvimopan is a drug used to speed up the time for return of bowel function after surgery. It works by blocking the opioid receptors in the gastrointestinal tract, which normally slow down bowel function in patients receiving postoperative opioid pain medication. It has not previously been tested in patients undergoing CRS/HIPEC.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent.
* Scheduled to undergo open (non-minimally invasive) CRS/HIPEC.
* Scheduled to receive postoperative pain management with intravenous opioids.
* Age \> 18 years.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
* Women of child-bearing potential with negative pregnancy test prior to initiating study drug dosing.

Exclusion Criteria:

* Greater than 7 days of consecutive opioid use immediately prior to scheduled surgery.
* Child-Pugh Class C hepatic impairment.
* End-stage renal disease (GFR \< 15 mL/min/1.73 m2 and/or on peritoneal dialysis or hemodialysis).
* Complete mechanical bowel obstruction.
* Contraindication or inability to tolerate oral medication postoperatively.
* Presence of gastrointestinal ostomy after CRS/HIPEC.
* Pancreatic or gastric anastomosis performed during CRS/HIPEC.
* History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition as alvimopan at the treating investigators discretion.
* Severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study treatment (i.e. uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements).
* History of myocardial infarction in the 12 months prior to scheduled surgery.
* Pregnant or nursing.
Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients with Solid Tumours

This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307) for treatment of patients with solid tumours,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).


Eligibility Criteria:
Inclusion Criteria:

* 1. Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol;
* 2. Age 18 to 70 years old;
* 3. Ovarian cancer that progresses after recurrence or first-line chemotherapy；
* 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
* 5. Expected survival time of ≥ 12 weeks;
* 6. Good function of vital organs;
* 7. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;
* 8. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.

Exclusion Criteria:

* 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
* 2.Known mental illness, alcoholism, drug use or substance abuse;
* 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
* 4.Those who have received other clinical trial drug treatment within 4 weeks before preconditioning by lymphodepletion,plan to participate in other clinical trial drug treatment during the study;
* 5.The investigators determine that other conditions that make the patient not suitable for enrollment.
Lung Function After Robot-assisted Radical Prostate Ectomy

The aim of our study is to investigate if the use of the AirSeal insufflation system impairs the lung function of patients less than a conventional system in patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP). Therefore we examine the lung function before and after surgery.

As a second purpose of the study, in a subgroup, we investigate the influence of the gas insufflators (AirSeal and conventional) on hemodynamics during surgery. Furthermore we study the change in the lung perfusion-ventilation-ratio by using the electric impedance tomography technique.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for RALP
* Written informed consent
* ≥ 18 years of age

Exclusion Criteria:

* Age under 18 years
* Patients who refuse participating in the study
* Obstructive airway disease (COPD and Asthma)
* Postoperative admission to an intensive or intermediate care unit
* Patients who do not speak German or English
Multicenter National Trial of Clinical Results of Surgical Elderly Patients

The aim of this study is to study clinical results including mrobidity and mortality of elderly patients (age \> 75 years) in Spain during a 3-month period.

The aim of the study it is to analyze the morbidity and mortality of patients older tha 70 admitted on hospital and who needs surgical operation. The results will be analysed in relationship with surgical risk calculator in order to know if it would be posssible to predict morbi-mortality of these cohort of patirents.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an age of 70 years old or older
* Admitted on hospital (minimum 1 day of hospital length)
* Needing surgery

Exclusion Criteria:

* Day case -surgery
Safety And Efficacy Study Of Depakote ER To Treat Pediatric Bipolar Disorder

The purpose of this research is to compare how safely and how well this medicine works in treating children and teenagers between the ages of 6 and 17 years with a diagnosis of Bipolar Disorder.

There is no accepted, well-studied treatment for Pediatric Bipolar Disorder and treatment has often followed from adult studies. The primary objectives for this study are to determine if subjects can safely and easily be switched from divalproex sodium to Depakote ER and to determine if Depakote ER is both safe and effective for pediatric patients with Bipolar I or II. Secondary objectives include determining the serum levels of valproic acid 20 hours after administration of Depakote ER at a steady rate and determining if co-administration of stimulants will effect the serum levels of valproic acid. Thirty subjects, ages 6-17 years, with a diagnosis of Bipolar I or II who are currently asymptomatic, according to a score of less than 10 on the Young Mania Rating Scale, or who desire to change to once daily dosing, or desire to change because of the likelihood of decreased side-effects, will be recruited from our clinic and the community. If subjects have completed baseline evaluations (including diagnostic confirmation), labs, and rating scales and are still eligible to participate, subjects will be switched in one night from twice-a-day divalproex sodium (DVP) to divalproex sodium extended release (DVP ER).

The potential benefits of the research are that new information will be added to the field of child and adolescent psychiatry and the possibility that the medication change may result in improved symptoms of mania or side effects of medications related to peak and trough levels. The potential benefits of this study outweigh the possible risks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Bipolar I or II confirmed by K-SADS and clinical interview.
* Ages 6 to 17 years 11 months.
* YMRS score of \<10, this is consistent with minimal symptoms of mania. Or a desire to change medications due to a simplified dosing schedule or to reduce unwanted side effects of divalproex sodium.
* Ability and willingness of subject and parent(s)/guardian(s) to provide informed written assent/consent.

Exclusion Criteria:

* Diagnosis of: Pervasive Developmental Disorders, Schizophrenia spectrum disorders, Obsessive Compulsive Disorder.
* Concurrent medical conditions requiring medication or that are unstable.
* Current suicidal thoughts.
* Recent suicidal behavior.
* Pregnancy or sexually active female not using a reliable form of contraception.
* Previous inadequate response to DVP ER.
* Known hypersensitivity to DVP or DVP ER.
* Recent inpatient hospitalization for suicidality or homicidality, (last 6 months).
* Subjects who are clinically stable and not suffering significant side effects on their current medical regimen.
* Use of antidepressants within the last 2 weeks, 4 weeks for fluoxetine.
* Recent (last 3 months) substance abuse or dependence. Urine drug screen will be obtained if a question arises.
Evaluation of the Protection of a Liquid Bandage

This study was designed with the objective of evaluating the protection potential provided by the experimental product (Liquid Bandage) by evaluating its barrier formation capacity. Once the product's ability to form a barrier is confirmed, its ability to protect against small skin injuries, such as small cuts and bruises, blisters and cracks, is confirmed. The barrier formation also guarantees protection against the formation of calluses.


Eligibility Criteria:
Inclusion criteria

* Age between 18 and 70 years old.
* Fitzpatrick skin phototype classification I to IV.
* Presence of intact skin in the test region (right forearm and left forearm for selected participants).
* Agreement to adhere to the study procedures and requirements and attend the institute on the days and times determined for the assessments.
* Signing of the Informed Consent Form (ICF) and the Image Disclosure Consent Form (IDCF) before carrying out any study procedure.

Exclusion Criteria

* Diagnosis of skin diseases such as vitiligo, psoriasis, atopic dermatitis.
* Diagnosis of immunological insufficiency.
* Use of systemic corticosteroids or immunosuppressants.
* Diagnosis of type 1 diabetes mellitus or insulin-dependent diabetes or presence of complications resulting from diabetes (such as retinopathy, nephropathy, neuropathy), presence of diabetes-related dermatoses (such as plantar ulcers, lipoid necrobiosis, granuloma annulare, opportunistic infections), history of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma.
* History of reaction to liquid dressings.
* Known hypersensitivity to any ingredients of investigational product formulation.
* Other diseases or use of drugs that may directly interfere with the study or put the research participant's health at risk.
* Presence of any serious or uncontrolled diseases, at the investigator's discretion.
* Pregnancy or lactation.
* Participation in a clinical research protocol in the last 12 months, unless, at the investigator's discretion, their participation in the study may result in direct benefit to the participant.
* Presence of any conditions that, at the investigator's discretion, make the participant unable to participate in the study.
Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions

The purpose of this study is to evaluate intranasal lorazepam in paediatric status epilepticus. This is a potentially, more effective, safer and cheaper treatment for a common paediatric medical emergency compared to our present first line therapy intramuscular paraldehyde.

The ideal first line anticonvulsant agent would be one that can be safely and easily given at a primary health care facility. It should be quick acting, have minimal cardiorespiratory side effects and have a relatively prolonged effect and be cheap. No combination of drug or delivery system fully satisfies these criteria. There are no large published studies evaluating intranasal lorazepam in paediatric status epilepticus. Given its favourable pharmacokinetics and potential practical advantages, we wished to assess the efficacy and safety of intranasal delivery of lorazepam compared to intramuscular paraldehyde, our existing first line anticonvulsant agent in the treatment of acute seizures in children.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 2 months and 12 years
* Presenting with generalised convulsions

Exclusion Criteria:

* Any child who had received an anticonvulsant agent within 1 hour of presentation
* Seizure stopped with rapid cooling or treatment of hypoglycaemia
* Features consistent with organophosphate poisoning, hepatic or hypertensive encephalopathy
Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System

The purpose of this study is to collect data on the use of the Ellipse MAGEC System to treat patients with adolescent idiopathic scoliosis (AIS) who have failed external brace therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Adolescent Idiopathic Scoliosis
* Failed external brace therapy defined as either (a) progression of the curve greater than 5 degrees at any time while undergoing external brace therapy, or (b) inability or unwillingness to comply with at least 16 hours per day of external bracing
* Skeletally immature (Risser Sign 0, 1, 2, or 3)
* In girls, either (a) pre-menarchal, or (b) post-menarchal by no more than 6 months
* Age between 10 and 15
* Primary Cobb angle greater than 25 degrees but not yet requiring spine fusion
* Candidate for surgical implantation of spinal instrumentation
* Patient resides locally with respect to the Investigator's clinic and is willing and able to comply with the requirements of the protocol
* Must sign informed consent to permit the use of personal health data

Exclusion Criteria:

* Patients with a pacemaker, implanted cardiac defibrillator, or any other electronic implant
* Patients who require an MRI following implantation
* Skeletally mature (Risser Sign 4 or 5; or fused tri-radiate cartilage)
* Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
* History of previous surgical treatment for AIS
Phase I/II Study of Human Anti-Cytomegalovirus (CMV) Monoclonal Antibody MSL-109 in Newborns With Symptomatic Congenital CMV Infection Without Central Nervous System Disease

OBJECTIVES: I. Evaluate the safety, tolerance, and potential efficacy of 3 doses of human anti-cytomegalovirus (CMV) monoclonal antibody SDZ MSL-109 (MOAB MSL-109) in the treatment of newborns with congenital CMV infection and no central nervous system disease.

II. Determine the relationship between plasma concentrations of MOAB MSL-109 and therapeutic outcome.

III. Determine whether MOAB MSL-109 influences the antibody response and clearance of virus from the urine.

PROTOCOL OUTLINE: Patients are treated with human anti-cytomegalovirus monoclonal antibody MSL-109, administered intravenously every other week for a total of 3 doses.

Groups of 6 patients are treated at each of 3 MSL-109 doses; there is no intrapatient escalation.

No concurrent therapy with antibiotics for systemic infection, parenteral antifungal agents, biological response modifiers, or other antiviral agents is allowed.

Patients are followed every 2 weeks for 6 weeks, every 4 weeks for 12 weeks, then annually for 5 years.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Symptomatic congenital cytomegalovirus (CMV) infection confirmed by urine culture No CMV acquired natally or postnatally Normal eye exam and skull x-ray, computerized tomography, or magnetic resonance imaging No evidence of central nervous system CMV, e.g.: Microcephaly, hydrocephaly, or hydranencephaly Intracranial calcification Chorioretinitis Normal cerebrospinal fluid Preterm: WBC no greater than 30 Protein less than 120 mg/dL Term: WBC no greater than 25 Protein less than 80 mg/dL --Prior/Concurrent Therapy-- At least 2 weeks since investigational drugs No prior or concurrent antiviral agents --Patient Characteristics-- Life expectancy: No imminent demise Renal: Creatinine no greater than 1.5 mg/dL Other: Birth weight at least 1200 g No congenital toxoplasmosis, congenital rubella, or syphilis No active systemic infection, i.e.: Bacterial Non-CMV viral, including HIV Protozoal Fungal No severe concurrent clinical condition, e.g.: Non-CMV congenital disease Genetic abnormality Moderate to severe hyaline membrane disease