cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Efficacy of a Modified Regimen of Ublituximab

The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab as measured by T1 Gadolinium (Gd)-enhancing lesions.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RMS (2017 Revised McDonald criteria).
* Participants must meet one of the following prior treatment definitions:

  1. Participants naïve to treatment.
  2. Participants previously treated with a DMT who have discontinued treatment prior to consent and meet the washout requirements.
* Expanded Disability Status Scale (EDSS) score ≤ 5.5 at screening.
* Neurologically stable for \> 30 days prior to first dose of ublituximab.

Exclusion Criteria:

* History of any Grade \> 3 Infusion Related Reaction (IRR) on prior anti-CD20 therapy.
* Primary-progressive multiple sclerosis (PPMS) or inactive Secondary Progressive MS (SPMS).
* Active chronic (or stable but treated with immune therapy) disease of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency, etc.).
* Current evidence or known history of clinically significant infection, including: chronic, recurrent, or ongoing active viral, bacterial, or fungal infectious disease requiring long term systemic treatment such as, but not limited to chronic urinary tract infection, chronic pulmonary infection with bronchiectasis, tuberculosis, or active hepatitis C virus (HCV).
* Previous serious opportunistic or atypical infection.
* Evidence of chronic active or history of hepatitis B virus (HBV) infection as evidenced by a detectable hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb), or chronic hepatitis C infection. Participants with positive hepatitis C virus antibody (HCV Ab) are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).
* History or evidence (clinical, radiological, or biomarker) of suspected or confirmed progressive multifocal leukoencephalopathy (PML).
* Receipt of any live or live-attenuated vaccines (including vaccines for varicella-zoster virus or measles) within 4 weeks prior to first study drug administration.
* Participants requiring treatment with intravenous immune globulin (IVIG) for decreased immunoglobulins within the 12 months prior to W1D1.
* Any active malignancies other than adequately treated basal, squamous cell or in situ carcinoma.
* Participants who have ever received ublituximab, alemtuzumab, cyclophosphamide, mitoxantrone, cladribine, or daclizumab (including for non-MS indications).
A Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese

The aim of this study is to find out how NNC0174-0833 taken with semaglutide works in people who are overweight or obese. Both study medicines have been investigated on their own. The study also looks at how the study medicines behave in participant's body and how they are removed from the participant's body. Participants will get 1 of the following 2 treatments - which treatment any participant gets is decided by chance: Semaglutide (a new medicine) and NNC0174-0833 (a potential new medicine), or semaglutide and placebo (a "dummy medicine similar to the study medicine but without active ingredients). Participants will get 2 injections per week for 20 weeks. A study nurse at the clinic will inject the medicine with a needle in a skin fold in the participant's stomach area. The study will last for about 16 months, but duration of participation for any participant will last up to about 7.5 months. Participants will have 28 clinic visits with the study staff and some will be overnight visits. Participants will be asked about their health, medical history and habits including mental health questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of non-childbearing potential, aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body mass index (BMI) between 27.0 and 39.9 kg/sqm (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

Exclusion Criteria:

* Any disorder at screening which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
* Male subject who is not sexually abstinent or surgically sterilised (vasectomy) and is sexually active with female partner(s) of childbearing potential and is not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the last dose of investigational medical product.
REDWIL: Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors

Surgical site infection is common in colorectal surgery leading to increased postoperative pain, longer hospital stay, delayed wound healing and increased re-operation rates. Hence, reducing the wound infection rate is a major aim in abdominal surgery.

Wound protectors were invented for retracting the abdominal wall and keeping the abdominal wall sterile in order to reduce bacterial colonialization of the wound and wound infections.

This is a prospective-randomized trial comparing use of wound protectors versus woven drapes in laparoscopic colon resections with minilaparotomy.


Eligibility Criteria:
Inclusion Criteria:

* elective laparoscopic colorectal resection with minilaparotomy

Exclusion Criteria:

* emergency operation
* patients under 18 years of age
Ultrasound Therapy and Therapeutic Exercise for Chemotherapy Induced Peripheral Neuropathy (CIPN)

The primary purpose of the trial is to determine the preliminary efficacy of therapeutic ultrasound in the treatment of pain and sensory disturbance related to chemotherapy induced peripheral neuropathy.

Thirty cancer patients with colon or colorectal cancer undergoing chemotherapy treatment including the agent oxaliplatin will take part in the study. Patients will be randomly assigned to either standard care alone (education and therapeutic exercises) or standard care plus 10 treatments of therapeutic ultrasound to the toes and fingers.

Participants in both groups will follow a home exercise program for a 6 week period. Therapeutic ultrasound will be administered daily (e.g., Monday to Friday) over the first two week period of the study.

Eligibility Criteria:
Inclusion Criteria:

1. adults18 or older,
2. receiving or have received chemotherapy treatment for colon or colorectal cancer,
3. chemotherapy regimen includes the agent oxaliplatin,
4. Grade 1, 2 or 3 on the National Cancer Institute Common Terminology Criteria for Adverse Events for sensory and motor neuropathy.

Exclusion Criteria:

1. neuropathy pre-existing the patient's cancer diagnosis;
2. contraindications to therapeutic ultrasound:

   * active cancer in region of hands or feet,
   * presence of deep vein thrombosis,
   * lack of sensation in hands or feet,
   * metal or plastic implants in hands or feet;
3. peripheral vascular disease or other serious existing non-malignant disease which may affect their ability to complete testing and treatment sessions.
Treatment of Thoracolumbar Spine Fractures: Percutaneously Placed Pedicle Screws Versus Open Treatment

In patients presenting with Type A and Type B1, B2 thoracolumbar fractures, there is a lack of evidence demonstrating similar outcomes between patients treated with percutaneous pedicle screws and those treated openly. It has been demonstrated that percutaneous pedicle screw fixation has fared well for patients in the short term; however, it is unclear whether the outcomes are equivalent or inferior/superior compared to open treatment.

The authors seek to establish a high-level evidence base to determine clinical patient outcomes, radiographic outcomes, as well as cost-effectiveness data in comparing thoracolumbar burst fracture patients treated with percutaneous pedicle screws, open treatment, and brace treatment. Additionally, the authors seek to establish data relating to patient occupational data, complications, and need for further surgery (revision/removal of hardware), as well as short-term variables relating to hospital visit (length of stay, estimated blood loss, time under fluoroscopy).


Eligibility Criteria:
Inclusion Criteria:

* All patients from ages 18 and older who present to Allegheny General Hospital with an acute thoracolumbar fracture will be considered eligible for the study (i.e. \<3 weeks from trauma date).
* Minor fractures around the fracture site or compression fractures will be permitted if they do not require treatment
* For the purposes of the study, patients must be English-speaking and live within the 100 mile radius from the greater Pittsburgh area for consent and follow-up purposes
* Patients who cannot safely undergo brace treatment due to comorbidities such as obesity, pulmonary injury, elderly status, reliability, and multitrauma
* Patients must have Type A or Type B1,B2 thoracolumbar fracture (must be able to correct deformity through percutaneous instrumentation)

Exclusion Criteria:

* Patients presenting with a neurologic deficit
* Patients who receive a laminectomy for decompression of the neural elements
* Patients who have a significant head injury
* Oncologic patients
* Women who were found to be pregnant or breast feeding at any point during their admission, hospital stay, treatment, or clinical follow-up.
* Individuals who are currently incarcerated.
* Adolescents under 18 years of age.
* Patients who have a relative contraindication to operative treatment will be excluded - infection, skin disease, bleeding disorder, etc.
Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS

The purpose of this study is to learn about the pharmacokinetics and pharmacodynamics of RPC1063 in RMS.

The purpose of this study is to characterize the full pharmacokinetic and pharmacodynamics profiles of RPC1063 in patients with relapsing multiple sclerosis (RMS) following multiple-dose administration of the two different dosing regimens that are being evaluated in the Phase 3 RMS studies.

Eligibility Criteria:
Key Inclusion Criteria:

* MS, as diagnosed by the revised 2010 McDonald criteria
* Exhibits a relapsing clinical course consistent with RMS and history of brain MRI lesions consistent with MS
* Expanded disability status scale (EDSS) score between 0 and 6.0

Key Exclusion Criteria:

* Primary progressive MS
* Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis

Primary Objective:

To determine the long-term safety and tolerability of SAR442168 in RMS participants

Secondary Objective:

To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging methods

Approximately 62 months including the 8 weeks post-treatment visit

Eligibility Criteria:
Inclusion criteria:

* Participants must have completed treatment in the DRI15928 study
* Female participants must continue to use an acceptable effective contraception method of birth control from inclusion and until the last dose of study drug, except if she has undergone sterilization at least 3 months earlier or is postmenopausal. Menopause is defined as being amenorrheic for ≥12 months with plasma follicle stimulating hormone (FSH) level \>30 UI/L.
* The participant must have given written informed consent prior to undertaking any study related procedure.

Exclusion criteria:

* The participant has a confirmed concomitant laboratory or ECG abnormality or medical condition deemed by the investigator incompatible with continuation of SAR442168 treatment.
* The participant has received any live (attenuated) vaccine (including but not limited to varicella zoster, oral polio, and nasal influenza) between the last DRI15928 visit and the first treatment visit in the LTS16004 study.
* The participant has received a non-study MS disease modifying treatment between the last IMP treatment in Study DRI15928 and inclusion in Study LTS16004, which by judgement of the Investigator may add unjustified risk to switching back and continuing treatment with SAR442168. Washout periods after treatment with non-study DMTs should be respected except for interferons or glatiramer acetate treatment.
* The participant is receiving strong inducers or inhibitors of CYP3A or CYP2C8 hepatic enzymes.
* The participant is receiving anticoagulant/antiplatelet therapies, including:

  * Acetylsalicylic acid (aspirin)
  * Antiplatelet drugs (eg, clopidogrel)
  * Warfarin (vitamin K antagonist)
  * Heparin, including low molecular weight heparin (antithrombin agents)
  * Dabigatran (direct thrombin inhibitor)
  * Apixaban, edoxaban, rivaroxaban (direct factor Xa inhibitors)

Note: All above drugs need to be stopped at least 5 half-lives before study drug administration except for aspirin, which needs to be stopped at least 8 days beforehand.

* Prior/concurrent clinical study experience. The participant is taking part in another interventional clinical trial of another drug substance.
* Uncooperative behavior or any condition that could make the participant potentially non-adherent with the study procedures
* The participant is pregnant or is a breastfeeding woman.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Celecoxib Efficacy And Safety Versus Diclofenac In Acute Pain Due To Cervical Sprain Related To A Traffic Accident

This Study Will Evaluate Celecoxib Efficacy And Safety Versus Standard Doses Of Diclofenac In Acute Pain Due To Cervical Injury (Due To A Sprain) Related To A Motor Vehicle Accident

On 21Oct2010 study was prematurely terminated due to poor enrollment with subsequent low number of participants. No safety or efficacy issues were involved in the decision to terminate prematurely.

Eligibility Criteria:
Inclusion Criteria:

* Patients That Had Suffered A Car Accident And Due To It Suffered A Cervical Sprain

Exclusion Criteria:

* Recent Cervical Sprains Or Other Cervical Conditions
LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases

RATIONALE: LMB-7 immunotoxin can locate tumor cells and kill them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of LMB-7 immunotoxin in treating patients who have leptomeningeal metastases metastases.

OBJECTIVES: I. Determine the toxicity of intrathecal LMB-7 immunotoxin in patients with leptomeningeal metastases. II. Identify objective therapeutic responses in this group of patients.

OUTLINE: This is a dose escalation study. Patients receive LMB-7 intrathecally on days 1, 3, and 5. Treatment may be repeated every 4 weeks if the patient does not demonstrate HAMA neutralizing antibodies to PE-38 in CSF, has stable or responding disease, and has not experienced greater than grade II toxicity. Three to six patients are entered at each dose level. Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience grade 3 or worse toxicity or a neuroradiology toxicity score of 10 or greater.

PROJECTED ACCRUAL: Approximately 15 to 24 patients will be accrued over one year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven primary intracranial or extraneural neoplasm with leptomeningeal metastases At least 30% of malignant cells in the cerebrospinal fluid, primary tumor, or metastatic tumor must react with the B3 mouse monoclonal antibody

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: ANC greater than 1000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.2 mg/dL Pulmonary: DLCO at least 60 Other: No neutralizing antibodies to Pseudomonas exotoxin Not pregnant or nursing Not allergic to penicillin

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No chemotherapy within past 4 weeks (6 weeks for nitrosoureas) unless there is evidence of disease progression in CNS No concurrent chemotherapy Endocrine therapy: Patients receiving corticosteroids must be on stable dose for 10 days prior to entry Radiotherapy: No radiotherapy to disease site within past 3 months unless there is evidence of disease progression in CNS No concurrent radiotherapy Surgery: Not specified
IMPROVE: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis

The aim of IMPROVE is to define the optimal maintenance therapy for ANCA-associated vasculitides (AASV) by comparing the AZA (standard regimen) with MMF in terms of efficacy, i.e. in preventing relapses.

HYPOTHESIS :

MMF might be more effective than azathioprine as maintenance drug in AASV patients, reducing by 50% relapse rate, with a same frequency of adverse effects

AASV, including Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA) and renal limited vasculitis (RLV), are progressive, multisystem, autoimmune diseases which require the prescription of immunosuppressive therapy. Treatment using corticosteroids and cytotoxic drugs has been standardised (ECSYSVASTRIAL project), but relapse rate remains high and treatment-related toxicity is non negligible. The IMPROVE trial aims to reduce this relapse rate by using mycophenolate mofetil (MMF) for maintenance therapy. The potential benefit of MMF has been suggested in a published open and uncontrolled study. Patients with newly diagnosed systemic AASV will be randomly assigned to receive either MMF or reference treatment with azathioprine (AZA), once remission has been obtained with cyclophosphamide and prednisone. MMF and AZA will be continued for a total of 42 months of therapy with concomitant prednisone dose tapering. The study will last 48 months. Hence, within the last 6 months of the study duration, the patients will not receive any immunosuppressive drugs.

The primary end-point will the disease-free period, taken as the period of time from remission until relapse or study end; secondary end-points will be adverse events, cumulative damage (assessed using damage score VDI) and immunosuppressive drug cumulative dose.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with WG, MPA or renal-limited vasculitis.
* ANCA positivity. ANCA positivity requires PR3-ANCA or a typical cANCA pattern by indirect immunofluorescence (IIF), preferably confirmed by anti-PR3 ELISA. MPO-ANCA determined by ELISA requires demonstration of pANCA, and pANCA by IIF requires confirmation by anti-MPO ELISA. Optionally, central review of ANCA serology can be performed.
* Age 18 to 75 years

Exclusion Criteria:

* Any cytotoxic drug within previous year, unless started within one months of entry and according to the protocol design
* Co-existence of another systemic autoimmune disease, e.g. SLE
* Hepatitis B or Hepatitis C infection
* HIV positivity
* Failure to achieve remission after 6 months of CYC therapy
* Failure to control progressive disease with induction protocol
* Malignancy (usually exclude unless agreed with trial co-ordinator)
* Pregnancy or inadequate contraception
* Age below 18 and above 75 years\*
* Endstage renal failure unless active extrarenal disease requires treatment (temporal dependency of hemodialysis is not an exclusion criterion)
* Inability for informed consent

  * After discussion with the trial administrator, patients less than 18 years may be incorporated on separate application according to the appropriate local ethic committee.
A Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer (SALUTE)

This is a placebo-controlled, double-blind, multicenter, randomized study for preliminary evaluation of the efficacy and safety of combining bevacizumab with cisplatin (or carboplatin) and etoposide in patients with previously untreated extensive-stage small cell lung cancer (SCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented small cell carcinoma of the bronchus, classified as extensive-stage disease
* Measurable disease or lesions
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

Exclusion Criteria:

* Life expectancy of \< 12 weeks
* Current, recent, or planned participation in another experimental drug study
* Ongoing or active infection
* Active malignancy other than SCLC or superficial basal/squamous cell carcinoma within the previous 5 years
* Prior systemic therapy, radiation therapy, or surgery for SCLC
* Inadequate bone marrow function, renal function, or hepatic function
* Serum sodium of \< 120 mg/dL
* Inadequately controlled hypertension
* History of hypertensive crisis or hypertensive encephalopathy
* New York Heart Association Class II or greater congestive heart failure
* History of myocardial infarction or unstable angina within 6 months prior to study enrollment
* History of stroke or transient ischemic attack within 6 months prior to study enrollment
* Known central nervous system disease, except for brain metastases treated with whole-brain radiotherapy
* Significant vascular disease or recent peripheral arterial thrombosis within 6 months prior to study enrollment
* History of hemoptysis within 4 weeks prior to study enrollment
* Evidence of bleeding diathesis or coagulopathy in the absence of therapeutic anticoagulation
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of a need for a major surgical procedure during the course of the study
* Core biopsy or other minor surgical procedure, including placement of a vascular access device, within 7 days prior to Day 1
* History of abdominal fistula or gastrointestinal perforation within 6 months prior to study enrollment
* Serious, non-healing wound, active ulcer, or untreated bone fracture
* Known hypersensitivity to any component of bevacizumab
* Pregnant (positive pregnancy test) or lactating
Comparison of Two Triple Regimens for Treatment and Retreatment of Chronic Hepatitis C Infection

The purpose of this observational study is to compare two approved treatment regimen(s) containing boceprevir and telaprevir, as part of standard of care for the treatment of hepatitis C.

The objective of the study is to compare the effect of adding 2 oral hepatitis C virus (HCV) protease inhibitors, telaprevir versus boceprevir, as part of current standard treatment regimen with (pegylated-interferon-alpha + ribavirin) for HCV Genotype-1 infection. Data will be obtained from medical records of consenting patients.

Eligibility Criteria:
Inclusion Criteria:

* Age - 18-64 years
* HCV genotype 1
* HCV RNA \>100,000
* Liver biopsy within 5 years before enrollment
* Absolute neutrophil count of at least 1200 per cubic millimeter
* Platelet count of at least 90,000 per cubic millimeter
* Hemoglobin level of at least 12 g per deciliter
* Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) forms

Exclusion Criteria:

* HCV genotypes other than genotype 1
* Immunocompromised conditions including HIV, transplant or immunosuppressive drugs
* Decompensated liver disease or hepatocellular carcinoma
* Any other types of active cancer
* Active autoimmune disorders
* Major psychiatric disorders
* Active drug or alcohol use
* Pregnancy or lactation
* Patients with allergy to any of the drugs used in this study
* Drugs that may interact with boceprevir or telaprevir as listed in the package insert