cyrilzakka/clinical-trials huggingface dataset:
Phase 2 Dose Finding sPIF in Patients With High Panel Reactive Antibodies

This is an open labeled dose finding adaptive design study. Patients with elevated cPRA values, 30-60% will be recruited and administered sPIF injected subcutaneously for 14 doses; one dose on Monday, Wednesday, Friday, or Tuesday, Thursday, Saturday, per individual patient dialysis schedule.

The purpose of this study is to determine the sPIF dose that reduces serum cPRA to \<30%, when administered 14 doses. Safety, tolerability, and efficacy will be evaluated at day 42 and and day 84. The suitability of a patient to receive a kidney transplant will also be monitored up to 6 months after Day 84. Safety and tolerability will be assessed at each of the increased doses and throughout the treatment duration. Exploratory analysis of blood indices will be carried out and changes based on history, physical and laboratory exams will be assessed according to the 12 systems.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient male and females 18-75 years old
* Able and willing to give written informed consent and comply with the requirements of the study protocol
* Calculated panel reactive antibody (cPRA) \>30% and \<60% with a threshold using mean fluorescent intensity (MFI) of 3,000 or standard fluorescence intensity (SFI) of 60,000 over six months.
* Women who are of childbearing potential must have a negative serum pregnancy test prior to being enrolled in the study and agree to use effective method of contraception throughout the 84-day study.
* Patients on kidney dialysis 3.3 Exclusion Criteria
* Patients not capable of following through the treatment for various reasons as determined by treating physicians
* Pregnant females
* Requiring blood transfusions
* Have an active infection
* Infection with hepatitis C virus (HCV) or hepatitis B virus(HBV) or human immunodeficiency virus (HIV), lack of documentation of treatment of a positive PPD, baseline leukopenia, white blood cell count (WBC) \<4.0, thrombocytopenia (platelet count \<100,000/mm) or difficult to treat anemia, a hematocrit chronically \<25% on intravenous iron and EPO (erythropoietin) therapy
* Active cancer within 5 years
* Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
A Study of Subcutaneous and Intravenous VELCADE in Patients With Previously Treated Multiple Myeloma

Randomized, open-label, international, multi-center, Phase 3 study in which patients are randomized to receive VELCADE administered by subcutaneous injection or intravenous infusion.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects 18 years or older
2. Diagnosis of multiple myeloma
3. Measurable, secretory multiple myeloma defined as serum monoclonal IgG of ≥10 g/L, serum monoclonal IgA or IgE ≥5 g/L, or serum monoclonal IgD ≥0.5g/L; or urine M-protein of ≥200 mg/24 hr
4. Relapse or progression of myeloma following prior systemic antineoplastic therapy.

Exclusion Criteria:

1. Previous treatment with VELCADE
2. More than 3 previous lines of therapy (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a greater than 6 month treatment-free interval)
3. Peripheral neuropathy or neuropathic pain of NCI CTCAE Grade ≥2
4. Any of the following within 3 weeks prior to randomization:

   antineoplastic or experimental therapy, corticosteroid use above 10mg a day (prednisone or equivalent), or plasmapheresis
5. Any of the following within 2 weeks prior to randomization:

   radiation therapy, major surgery (kyphoplasty is not considered major surgery)
6. Prior malignancy other than multiple myeloma diagnosed or treated within the last 2 years, with the exception of completely resected carcinoma in situ or basal/squamous carcinoma of the skin
A Clinical Comparison of Three Contact Lens Care Systems and Their Effect on Contact Lenses

The purpose of this study was to evaluate the clinical performance of three differing contact lens care solutions when used in conjunction with three contact lenses.

This study was conducted as three separate studies based on the contact lens brand dispensed. In each study, the contact lens was evaluated in conjunction with three solutions: Opti-Free Replenish, ReNu MultiPlus, and Clear Care. The total enrollment number of 75 represents a combined enrollment of the three studies, with some subjects participating in more than one study.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Adapted contact lens wearer for at least one month.
* Spherical prescription range between +6.00 to -8.00 diopters.
* Astigmatism of less than or equal to 1.00 diopter in at least one eye.
* Normal eyes with no evidence of abnormality or disease.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Rigid Gas Permeable (RGP) contact lens wear in last 30 days.
* Concurrent ocular medication, systemic illness, or medical treatment that will affect ocular physiology, lens performance, or vision.
* Corneal infiltrates, scarring, or neovascularization within central 4 millimeters of cornea.
* Eye injury or surgery within 8 weeks prior to study.
* Aphakia, amblyopia, abnormal lacrimal secretions, ocular irritation, keratoconus, corneal irregularity, pregnancy, lactating, planning to become pregnant during the study, and participation in a concurrent clinical trial.
* Other protocol-defined exclusion criteria may apply.
Optivol Diagnostic Data for Discharge in Heart Failure

The objective of this study is to evaluate whether the heart rate variability, daily heart rate, and/or intrathoracic impedance recorded by implantable cardiac devices can be used in conjunction with other traditional clinical practice methods to determine if heart failure patients are ready for hospital discharge.

Implantable cardioverter defibrillator (ICD) devices with or without cardiac resynchronization therapy (CRT-D) have the ability to continuously monitor heart rate variability, daily heart rate, and patient activity. Changes in these measures have been associated with heart failure prognosis. In addition, ICD or CRT-D devices also have the ability to measure daily intrathoracic impedance. Previous data have demonstrated that device-based intrathoracic impedance measurements correlate with pulmonary capillary wedge pressure and fluid retention, both of which are common measures of heart failure status. The objective of this study is to evaluate whether the heart rate variability, daily heart rate, and/or intrathoracic impedance can be used in conjunction with other methods to determine if patients are ready for hospital discharge. This will be the first step in potentially developing an inpatient care strategy which includes implantable device data. It is hypothesized that device diagnostic data will identify an appropriate and safe time to discharge patients admitted for worsening heart failure symptoms before usual clinical indicators. More specifically, we hypothesize that device data will "normalize" at least one day prior to the clinical indicators of readiness for discharge and patients discharged prior to "normalization" of the device data will be at greater risk for rehospitalization

Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with a Medtronic InSync Sentry or subsequent FDA-approved Medtronic device with the OptiVol capability for \>30 days.
* Anticipated hospitalization stay \>48 hours
* Hospitalized patients experiencing worsening heart failure with symptoms of lung/pulmonary congestion.

Exclusion Criteria:

* Anemia - admission hemoglobin \<8.0 g/dL
* Patients residing in convalescence center prior to admission or known to be discharged to a convalescence center or hospice, where discharge could be based on bed availability
Misoprostol Versus Active Management of Labour in CS

Several treatment strategies are emplemented to prevent post delivery hemorage and decreasing maternal morbidity and mortality .

Many approved drugs are used in prophylaxis against postpartum hemorage from these medications are the (syntocinon combined with methergine ) that are known as active management of labour drugs .

Moreover there is misotac , that also guards against postpartum hemorage .

All these medications act in a different way to cause uterine contraction post delivery to prevent uterine atony .

-Here we are comparing the additive value of misotac intrauterine to syntocinon and methergine in comparison to the usually used syntocinon plus methergine .

Eligibility Criteria:
Inclusion Criteria:

* • All patients included in this research were aged 18-42 years, pregnant 37 weeks till 42 weeks

  * no medical disorders with pregnancy e.g DM, HTN. All patients were subjected to full history taking, examination.

Exclusion Criteria:

* Exclusion Criteria:

  * The following patients were excluded , GA before 37 weeks or after 42 weeks , medical disorders with pregnancy eg. DM with pregnancy, HTN with pregnancy
The Value of Follow-Up After Childhood Acute Lymphoblastic Leukaemia in Denmark - Family Perspectives

The aim of the study is to evaluate the family perspective on follow-up programs after treatment for childhood acute lymphoblastic leukaemia. It is relevant when new follow-up programs are to be designed.

More than 90 % of paediatric patients with acute lymphoblastic leukaemia (ALL), treated on the Nordic Society of Pediatric Hematology and Oncology (NOPHO) ALL-2008 protocol, are alive five years after diagnosis. The main reason for treatment failure being relapse.

The risk of relapse after treatment for ALL is highest within the first two years after cessation of maintenance therapy. Therefore, it has been routine in most countries to follow-up patients in the outpatient clinic every one or two months during the first years after end of therapy for ALL in order to detect recurrence and possible late sequelae at an early stage.

In children with ALL there are only a few studies on the value of routine follow-up, including haematological status after cessation of maintenance therapy. These studies showed that approximately 90% of the relapses were diagnosed in children with symptoms of leukaemia progression and that routine blood tests and clinical follow-ups were of little value. It is well known that there are other issues besides the risk of relapse, which are relevant for families after cessation of ALL therapy i.e. risk of late effects of treatment, psychosocial problems related to the child's return to "normal" life etc. These issues will also have an impact upon how the follow-up programs are planned. The investigators will study the family perspectives on follow-up during the first 5-years after cessation of maintenance therapy in a Danish cohort of children treated according to the NOPHO ALL-2008 protocol.

The investigators will conduct a cross-sectional study. Outcomes are patient-reported as the measurement instrument used is questionnaires. Eligible families are families with children diagnosed with acute lymphoblastic leukaemia in Denmark and being in the period 0-5 years after cessation of maintenance therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with B-precursor ALL and T-ALL enrolled in the NOPHO ALL-2008 trial
* Age group 1.0-14.9 years.
* Patients treated on one of the four Danish Paediatric oncology departments
* Patients in the time period 0-5 years after cessation of maintenance therapy for ALL

Exclusion Criteria:

* A history of recurrence or second malignancies
* Bone marrow transplantation
* Down syndrome
* If, due to language barriers, the family is unable to complete the questionnaire.
A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis

The purpose of this study is to evaluate the pharmacokinetics (PK), efficacy, safety and immunogenicity of ustekinumab and guselkumab in active juvenile psoriatic arthritis (jPsA).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of juvenile psoriatic arthritis (jPsA) by Vancouver criteria with exclusion of enthesitis-related arthritis (ERA). Diagnosis made \>=3 months (that is, 90 days) prior to screening
* Active disease in at least greater than or equal to (\>=) 3 joints at screening and at week 0 (defined as swelling or loss of motion with pain and/or tenderness. Swelling alone meets the criteria for an active arthritic joint. In the absence of swelling, loss of motion with pain or tenderness or both pain and tenderness meet the criteria for an active arthritic joint
* Have active disease despite previous non-biologic disease modifying anti-rheumatic drug (DMARD) and/or non-steroidal anti-inflammatory drug (NSAID) therapy: Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 12 weeks or evidence of intolerance; NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance
* Concurrent use of methotrexate, sulfasalazine, leflunomide, oral corticosteroids or NSAIDs is permitted but must be on stable dose
* Participants must be up to date with all immunizations in agreement with current local immunization guidelines for immunosuppressed patients
* Prior use of anti-TNFα agents, IL-17 inhibitors and other biologics (except non-responders to IL-23 inhibitors) and JAK inhibitors are permitted with sufficient washout period

Exclusion Criteria:

* Participants with enthesitis-related arthritis (ERA)
* Have a history of latent or active granulomatous infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis prior to screening
* Have a history of, or ongoing, chronic or recurrent infectious disease
* Has evidence of herpes zoster infection within 8 weeks prior to Week 0
* Have a known history of hepatitis C infection or test positive at screening
Localized Therapeutics for the Treatment of Gastrointestinal Disorders II

The purpose of this study is to investigate a novel thermosensitive topical gel formulation for the treatment of inflammatory bowel disease (IBD), specifically ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily sign written informed consent.
* Male or non-pregnant and non-lactating females at least 8 years of age.
* Confirmed diagnosis of active, mild to moderate ulcerative proctitis or proctosigmoiditis extending no further than 40cm from the anal verge. Typically, baseline Mayo Disease Activity Index (MMDAI) score between 5 and 10 (indicating mild to moderate disease).

Exclusion Criteria:

* Known infection with Clostridium difficile (C. difficile) and/or other enteric pathogens
* 5-aminosalicylic acid (5-ASA) intolerance
* Current or recent (3 weeks) oral or rectal steroids
* History of thiopurine or Anti-tumor necrosis factor (Anti-TNF) alpha treatment for colitis
* Abnormal creatinine
* Previous small bowel or colonic resection,
* Anal sphincter incompetence,
* Current smokers.
* History or current diagnosis of Crohn's disease or indeterminate colitis.
* History of diverticulitis, collagenous colitis, celiac disease, recurrent pancreatic or known gallbladder disease.
* Unstable significant cardiovascular, endocrine, neurologic or pulmonary disease.
* Hemoglobin levels \< 7.5 g/dL.
* History of sclerosing cholangitis, cirrhosis, or hepatic impairment
* Pregnant or at risk of pregnancy.
* Some medications to treat UC are prohibited during participation in the study, including laxatives and anti-diarrhea medications; oral 5-ASA agents and daily fiber supplements are allowed.
ED50 and ED95 of Intrathecal Hyperbaric Bupivacaine With Fentanyl for Transurethral Prostatectomy in Elderly Patients

As people age, the incidence of prostate hyperplasia increases. So patients under Transurethral Resection of Prostate(TURP) or Holmium Laser Ennucleation of Prostate(HoLEP) are mostly ole age people. Most old age patient has several underlying disease. So patients can develop high mortality and morbidity. Most surgeries for Prostate Resection are taken under Spinal anesthesia. Adequate block level for Prostate Resection is T10. But sometimes, old age patients can develop severe complication after spinal anesthesia. So we started this study to know the adequate drug concentration for Spinal anesthesia taken for Prostate Resection surgery.

As people age, the incidence of prostate hyperplasia increases. So patients under Transurethral Resection of Prostate(TURP) or Holmium Laser Ennucleation of Prostate(HoLEP) are mostly ole age people. Most old age patient has several underlying disease. So patients can develop high mortality and morbidity. Most surgeries for Prostate Resection are taken under Spinal anesthesia. Adequate block level for Prostate Resection is T10. But sometimes, old age patients can develop severe hypotension and vital unstability due to unintentional high sensory and motor blocks. These complications are due to the decreased cerebrospinal fluid volume with increase of age. So we started this study to know the adequate drug concentration for Spinal anesthesia taken for Prostate Resection surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for TURP \& HoLEP under spinal anesthesia
* Male between 65 and 100
* The American Society of Anesthesiologists physical status class 1 or 2

Exclusion Criteria:

* Patients with coagulopathy
* Patients with infectious disease
* Patients with a drug allergy
* Patients under 50kg or over 100kg
* In case of switching to general anesthesia
Role of Opioids in Epidural Solutions

It is unclear whether addition of opioids to epidural solutions for postoperative analgesia is beneficial. In this multicenter randomized double-blinded trial, we aim to test the primary hypothesis that epidural solutions containing only bupivacaine are as effective as solutions containing both bupivacaine and fentanyl in promoting analgesia in patients recovering from open abdominal surgery. We also aim to assess the incidence of epidural-induced hypotension, the difference in patient-reported opioid side-effects between the two groups. If we demonstrate no clinically important difference between the two interventions, clinicians will be able to substantially reduce the amount of opioids patients receive during their postoperative recovery, and potentially decrease the associated high incidence of opioid adverse effects in post-surgical patients.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. 18-85 years old
3. Undergoing open abdominal surgery (including colorectal, intestinal, gastric, pancreatic, hepatobiliary, urological, or gynecological surgery)
4. For which a clinical decision has been made to provide epidural analgesia preoperatively and extending to the post-operative period
5. Anticipated hospitalization of at least 2 nights

Exclusion Criteria:

1. Known allergy to bupivacaine or fentanyl
2. Chronic liver disease, defined as cirrhosis, portal hypertension, or variceal bleeding
3. Patients under chronic alpha-blocking agents for hypertension
4. Clinical contraindications to epidural introduction, as judged by the anesthesia provider (thrombocytopenia, un-interrupted anticoagulation, clinically-significant atrio-ventricular conduction block, etc.)
5. Pregnant women
ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain

The purpose of this enhanced surveillance study ("ESS") is to collect information regarding chronic adverse events that are possibly related to the ExAblate® System ("ExAblate") that are received by InSightec ("InSightec") following PMA approval. This study will examine adverse events reported in patients undergoing the device procedure for the first two years of commercial experience. Other relevant data may be collected as well.

This proposed Registry will be performed in full compliance with all HIPAA rules and their implementations at potential participating sites. All patients planned to undergo the ExAblate procedure in a commercial setting after PMA approval will be offered a consent so they can be included in the ESS. Non-consenting patients will not be included in the ESS. However, information regarding the total number of subjects treated at each participating site with the device will also be collected.

InSightec will set up a (password protected) EDC database for the sites to enter the information of participating subjects treated with the ExAblate device from all U.S. sites using the ExAblate procedure for the bone metastases indication. This will occur for a total duration of 2 years following device approval. It should be noted that any adverse event that meets the Medical Device Report ("MDR") definition will be reported as an MDR as well.

There will be no control group. Reporting to FDA will occur at six-month intervals for the first two-years after PMA approval.

Eligibility Criteria:
This study collects safety data on patient treatments performed commercially under the FDA approved labeling.

* Eligibility is as per approved device indication.
* All registry-consented patients who undergo commercial ExAblate procedure for bone mets palliation after device approval.
Molecular Epidemiology of Clostridium Difficile Infections in Children

Objectives:

1. Describe the molecular epidemiology of Clostridium Difficile infection in children in the Chicago area.
2. Determine the clinical spectrum and risk factors for Clostridium Difficile infection secondary to particular endemic strains in children.
3. Define the risk factors for recurrent and community-associated Clostridium Difficile infection in children.


Eligibility Criteria:
Inclusion Criteria:

* Clostridium Difficile infection

Exclusion Criteria:

* Age \< 1 year
* Age \> 18 years
CYA Versus MMF for Treatment of Moderate-Severe Psoriasis.

Psoriasis is an immuno-mediated skin disorder, which affects about 2-3% of the population worldwide. For moderate-severe forms of psoriasis systemic immunosuppression is the treatment of choice. This clinical trial was initiated to compare the safety and effectiveness of mycophenolate mofetil and cyclosporine A for the treatment of psoriasis. Patients are randomized to receive either 2.5 mg/kg BW cyclosporine A or 1 g bid mycophenolate mofetil. If after six weeks no decrease in the PASI score occures cyclosporine A doses are increased to 5 mg/kg BW for additional six weeks. In the other arm mycophenolate mofetil is increased to 1 g tid for additional six weeks.

Not needed.

Eligibility Criteria:
Inclusion Criteria:

* moderate-to-severe psoriasis (PASI Score equal and greated 10)
* written informed consent
* for female patients effective birth control

Exclusion Criteria:

* psoriasis arthritis
* psoriasis palmo-plantaris
* erythrodermic psoriasis
* drug-induced psoriasis
* pregnancy
* previous treatment with cyclosporine A or mycophenolate mofetil
* pregnancy
* reduced liver function
* high blood pressure
* reduced kidney function
* severe viral or bacterial infection
* 2 weeks before or after vaccinations
* innate or acquired immunodeficiency
* severe neurologic or psychiatric symptoms
* participation in other trials
* other reasons voiced by the treating physician
Organ Protection With Sevoflurane Postconditioning

Organ protection, volatile anesthetics, postconditioning, hepatic surgery

This study aims at the evaluation of a potential attenuation of ischemic-reperfusion injury in the liver with sevoflurane postconditioning upon reperfusion.

Eligibility Criteria:
Inclusion criteria:

* older than 18 years
* patients undergoing liver resection (benign or malignant tumors)

Exclusion criteria:

* non-german speakers
* laparoscopic liver resection
* coagulopathy (platelets \< 50'000/ml, Quick \< 50%)
* liver cirrhosis