cyrilzakka/clinical-trials huggingface dataset:
Extension Study Of Tanezumab In Osteoarthritis

Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab

This study was terminated on 27 October 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Eligibility Criteria:
Inclusion Criteria:

* Must have participated in previous (specific) Phase 3 trials of Tanezumab in osteoarthritis

Exclusion Criteria:

* Willing to comply with scheduled visits and treatment plan Is medically fit to participate in the trial in the judgement of the Investigator
Suppression of Oral HHV8 Shedding With Valganciclovir

The purpose of the study is to use valganciclovir to define the role of antiviral therapy in suppression of HHV-8 shedding in HHV-8 seropositive men. Our hypothesis is that valganciclovir will substantially reduce the frequency of detection and amount of HHV-8 in the mouth.

The purpose of the study is to use valganciclovir to define the role of antiviral therapy in suppression of HHV-8 shedding in HHV-8 seropositive men. Our hypothesis is that valganciclovir will substantially reduce the frequency of detection and amount of HHV-8 in the mouth. Such reduction will serve to confirm that the mouth is the site of active HHV-8 replication. If valganciclovir is found to be effective, the findings from this proposal would serve as the basis for a clinical trial with valganciclovir for prevention of Kaposi's Sarcoma (KS) in high-risk HHV-8 seropositive persons.

After informed consent, all subjects will undergo medical history, physical examination and screening laboratory examination. Eligible patients will return to clinic for randomization to receiver either valganciclovir 900 mg qd or placebo. Participants will receive a diary for noting adverse events and concurrent medications. The clinician will instruct the participants on collection of mouth swabs and provide Dacron swabs, vials with PCR media and pre-printed labels. Subjects will be asked to obtain a swab of oral mucosa every morning. Clinic visits every other week will serve to review interim medical history and diaries for adverse events, collect PCR swabs, dispense additional medication and draw safety labs. The study uses a double-blind, randomized placebo design. Therefore, participants will not know whether they will be taking a placebo or active medication at any time during the study. Due to the crossover study design, however, all participants will receive the same amount of placebo and study drug over the duration.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* HHV-8 seropositive or previous evidence of HHV-8 shedding
* a frequent shedder of HHV-8
* not receiving any drugs with known anti-HHV-8 activity for study duration
* able to comply with the study protocol
* agree to HIV testing

Exclusion Criteria:

* history of evidence of CMV disease
* hypersensitivity to ganciclovir or valganciclovir
* use of high-dose acyclovir, valacyclovir, famciclovir, ganciclovir, foscarnet, or cidofovir
* neutropenia
* renal insufficiency with serum creatinine greater than 1.5mg.ml or CrCl less than 60
* AST or ALT greater than 5 times upper limit of normal
* concurrent administration of medications which are often associated with severe neutropenia or thrombocytopenia
* concurrent administration of probenecid or didanosine
Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase) in Elderly Patients With First Line Acute Lymphoblastic Leukemia

The main purpose of this study is to determine the maximum tolerated and efficient dose of GRASPA® in combination with polychemotherapy treatment of elderly patients with ALL, 55 years and over, Philadelphia chromosome-negative (ALL Ph-).

This open label, non randomised, multicentric and national phase IIa study was designed to evaluate the safety and efficacy of GRASPA®, a suspension of red blood cells encapsulating E. Coli L-asparaginase, at different doses and in combination with the polychemotherapy regimen recommended by the European Working Group on Adult ALL (EWALL) for frontline therapy of patients with ALL Ph-, aged 55 years old and over. Patients with a good performance status (WHO score ≤2) and a newly diagnosed ALL Ph- were treated with the backbone polychemotherapy consisting of a first 4-week induction phase comprising dexamethasone, vincristine and idarubicin, a second 4-week induction phase including cyclophosphamide, cytarabine, a 6-month consolidation phase consisting of 6 alternating cycles with methotrexate, asparaginase and folinic acid (cycles 1, 3 and 5) and high-dose cytarabine (cycles 2, 4 and 6) with Granulocyte colony stimulating factor (G-CSF) support followed by a 16-month maintenance period with mercaptopurine, methotrexate and vincristine/dexamethasone pulses. GRASPA® was administered on day 3 of induction 1 and on day 6 of induction 2 of the chemotherapy regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥55 years old
* With newly diagnosed ALL without prior treatment
* Capable to receive polychemotherapy (World Health Organization (WHO) performance status ≤2)
* With or without meningeal disease
* Having signed an Informed Consent Form
* Subscribed to social security insurance

Exclusion Criteria:

* ALL translocation(9;22) and/or BCR-ABL (Breakpoint Cluster Region-Abelson) positive
* Performance status incompatible with chemotherapy treatment (WHO score \>2)
* Patient presenting with a general or visceral contraindication to intensive treatment including :

  * Cardiac insufficiency defined as Left Ventricular Ejection Fraction \<50% of the theoretical value
  * Plasma creatinine concentration 2 times greater than the upper limit of laboratory ranges, except if related to ALL
  * Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) levels 5 times greater than the upper limit of laboratory ranges, except if related to ALL
  * Patient with another evolutive cancer other than ALL
  * Severe evolutive infection, or Human Immunodeficiency Virus (HIV) seropositive or, active hepatitis related to B or C viral infection
* Prior treatment with L-asparaginase (irrespective of the form)
* History of grade 3 transfusional incident (life threatening)
* Patient presenting rare and/or dangerous anti-erythrocyte antibodies thus leading to the unavailability of phenotype compatible Red Blood Cells Concentrate
* Patient included in another clinical trial during the last 4 weeks
Optimized MRI of Patients With Hip Arthroplasty

This is a single-center single-arm clinical trial with a paired design which compares the effectiveness of 3T MRI with (modified) and without (standard) radiofrequency pulse polarization optimization in reducing metal-related artifacts in patients with hip arthroplasty implants.

Twenty participants with symptomatic primary total hip arthroplasty will be imaged with both methods. The results of the two methods will be compared in reference to the size of the artifact-degraded regions, visibility of the normal structures and the rate of abnormality detection.Primary Objective: To assess the size of the artifact-degraded regions, defined as regions of the image where underlying anatomic structure are obscured, between modified and standard MRI protocols. Secondary Objectives: (1) To assess the visibility of normal structures between modified and standard MRI protocols. (2) To assess the abnormality detection rate using modified and standard MRI protocols.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 with unilateral symptomatic (e.g. pain) total hip arthroplasty
* Referred for MRI examination at the discretion of the treating physician
* Provision of signed and dated informed consent form
* No metal hardware in the body including contralateral hip arthroplasty
* No contraindication to MRI: defined as claustrophobia or presence of other MRI-incompatible devices

Exclusion Criteria:

* History of revision hip arthroplasty
* Pregnancy (self-reported, or self-suspected)
* Hip arthroplasty surgery within one year of enrollment
* Clinical indication to administer intravenous contrast material during MRI
6-year Antibody Check After Third Vaccination Against Japanese Encephalitis

The purpose of this study is to determine whether there are persisting antibodies against Japanese Encephalitis 6 years after the last vaccination with IXIARO(R) and to adapt or confirm mathematical models accordingly.

Japanese Encephalitis (JE) is a potentially devastating mosquito-borne viral disease. The JE virus (JEV), a Flavivirus, is endemic to many regions in Asia, and while JE is primarily a pediatric disease in the endemic regions, travelers from non-endemic regions to Asia are usually naïve to the virus and may be at risk for contracting JE at any age.

The present study aims to investigate antibody titers at approximately 6 years after the third dose of JE vaccine (JE-VC), in a cohort of participants from an earlier booster dose trial, to strengthen the statistical model of the duration of protection after the booster.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who received a booster dose of JE-VC in study IC51-311
* Subjects who are willing to give written informed consent to participate in the trial

Exclusion Criteria:

* Subjects who received a further dose of any Japanese Encephalitis Vaccine since study IC51-311
* Severe immunosuppression (as result of medical conditions or medication) since study IC51-311, such as history of radiation therapy or cytostatic therapy
* simultaneous participation in another clinical study
Tecfidera Slow-Titration Study

The primary objective of the study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the incidence of dimethyl fumarate (DMF \[Tecfidera\])-related gastrointestinal (GI) adverse events (AEs) in participants with multiple sclerosis (MS). The secondary objective of this study is to assess whether a 6-week titration (compared with a 1-week titration) is effective in reducing the average severity and duration of GI symptoms over 12 weeks of DMF treatment in this study population.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of MS consistent with locally labeled indication for DMF
* No prior treatment with DMF
* Female subjects of childbearing potential who are not surgically sterile and male subjects must practice effective contraception during their participation in the study
* Have had a recent complete blood count (CBC), including lymphocyte count, that does not preclude participation in the study, in the judgement of the investigator

Key Exclusion Criteria:

* Have a recent history or ongoing GI illness (e.g., peptic ulcer, irritable bowel syndrome) or any other current condition with GI signs and symptoms (e.g., nausea, vomiting, abdominal pain, or diarrhea) that may interfere with assessment of study endpoints
* Have other major comorbid conditions that preclude participation in the study, as determined by the investigator
* Participant is pregnant, breastfeeding, or planning a pregnancy during the study period
* Are receiving concomitant disease-modifying therapies for MS including, but not limited to, natalizumab, interferon beta, glatiramer acetate, fingolimod, alemtuzumab, teriflunomide, or laquinimod at screening
* History of severe allergic or anaphylactic reactions or known drug hypersensitivity
* NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Study of Intravenous Aflibercept in Combination With FOLFIRI in Japanese Patients With Metastatic Colorectal Cancer

The primary objective is to determine the dose of aflibercept to be further studied in combination with irinotecan/5-fluorouracil/isovorin (FOLFIRI) in Japanese patients with metastatic colorectal cancer.

Secondary objectives of this study are to assess the safety profile of aflibercept, to determine the pharmacokinetics of aflibercept, to make a preliminary assessment of antitumor effects.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically proven malignant tumor of the colon or rectum which is metastatic and inoperable.
* Patients must have received at least one prior line of treatment with any standard of care, who have failed the treatment, or who have not been eligible for standard of care for safety reasons.

Exclusion Criteria:

* Treatment with chemotherapy, hormone therapy, radiotherapy, surgery, blood products, or any investigational agent within 28 days.
* ECOG Performance Status\>1
* Anticipated need for a major surgical procedure or radiation therapy during the study.
* Uncontrolled malignant ascites.
* History of brain metastases, spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease on screening CT or MRI scan.
* Pregnant or breast-feeding women.
* Uncontrolled hypertension
* Patients who have previously been treated with aflibercept
* History of abdominal fistula, GI perforation, or intra-abdominal abscess within the past 28 days.
* History of hypersensitivity to any recombinant proteins, irinotecan, fluoropyrimidine or isovorin.
* Known dihydropyrimidine dehydrogenase deficiency.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The U.S. PDA Registry

The objective of this study is to demonstrate the continued safety and efficacy in a real-world setting of transcatheter device closure of the PDA in premature infants less than 2kg in weight at the time of device implant using the Amplatzer Piccolo Occluder device and other devices performed in the USA.

Based on the IMPACT registry, there are over 6000 transcatheter device closures of PDA that occurs in the United States annually. However, there are no comprehensive data collection tools for this procedure. The current databases do not include multiple data points, or follow-up data, or a section for specific adverse events to be documented. Moreover, until now, there has been no approved devices for PDA closure in children \< 2kg. This clinical study is the first of its kind to collect data from all transcatheter device closure of PDA in children \< 2kg performed in the USA.This study will be limited to children between 700 to 2000 grams who are the most vulnerable population undergoing this procedure. This will allow us to understand the real world experience (efficacy and safety) of using the Amplatzer Piccolo Occluder and other devices in an extremely vulnerable, yet highly underserved population. The study will allow for standardization of this procedure throughout the country for the small children (\<2 kg) with a PDA. This is a multi-center, single arm, observational data collection study. This will be a large population study to help analyze outcomes in subjects \<2 kg. The trial has two primary endpoints for safety and effectiveness without formal hypothesis. The safety and effectiveness results will be compared with data reported in the ADO II AS IDE and Continued Access Protocol studies.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of PDA.
2. Clinical indication for transcatheter PDA closure (discretion of the physician).
3. Weight \<2 kg at the time of device implant.

Exclusion Criteria:

1. Weight \<700 gm or greater than or equal to 2 kg at the time of device implant.
2. Age \< 3 days at the time of device implant.
3. Pre-existing coarctation of the aorta.
4. Pre-existing left pulmonary artery stenosis.
5. Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension.
6. Intracardiac thrombus that interferes with device implant.
7. Active infection requiring treatment at the time of impant.
Vitamin D Regulation of Gut Specific B Cells and Antibodies Targeting Gut Bacteria in Inflammatory Bowel Disease

Specific Aim 1: Characterize the effects of vitamin D treatment on expression of α4β7 on B cells in patients with inflammatory bowel disease (IBD).

Specific Aim 2: Determine the effects of vitamin D treatment on fecal immunoglobulins, percentage of Ig-coated gut bacteria, gut microbiome composition (global and bound by immunoglobulins) in patients with IBD and the association of these parameters with change in α4β7+ B cells .

Specific Aim 3: Compare BCR repertoire (BCR clonotypes, immunoglobulin heavy chain gene (IGHV), and isotype usage) between α4β7+ and α4β7- B cells in patients with IBD and identify α4β7+ BCR clonotypes associated with Ig-bound gut bacteria .


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years or older) with inflammatory bowel disease (ulcerative colitis or Crohn's disease)
* Low serum vitamin D (25(OH)D ≤ 25 ng/mL
* Not currently on high dose vitamin D supplementation
* No prior bowel resections
* No antibiotic use in past 3 months.

Exclusion Criteria:

* Patients less than 18 years old
* No diagnosis of IBD
* Serum 25(OH)D \> 25 ng/mL
* Patients already on vitamin D supplementation
* Prior history of bowel surgery (colectomy or small bowel resections)
* Recent antibiotic use in past 3 months
* Renal Dysfunction
* History of Hypercalcemia
* History of HIV
* History of IgA deficiency
* History of Common Variable Immunodeficiency (CVID)
* Active C. diff infection
Retrospective Assessment of AE-Related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma

This was a retrospective cohort study using Truven Health Analytics' MarketScan Commercial Claims and Encounters and Medicare Supplement and Coordination of Benefit administrative claims databases. The analysis was conducted using the most recent 5 years of data from the database, 01 January 2015, to 28 February 2021 (study period). Included patients were followed for outcome evaluation from the index date (first prescription of treatment, immunotherapy \[IO\] or targeted therapy \[TT\] following diagnosis of non-metastatic malignant melanoma and evidence of first lymph node resection), until the first occurrence of end of continuous eligibility or end of the study period.


Eligibility Criteria:
Inclusion Criteria:

* Patients with at least one diagnosis of malignant melanoma of skin (The International Classification of Diseases, 9th Revision, Clinical Modification \[ICD-9\] codes: 172.0-172.9 or V10.82; ICD-10 (10th revision) codes: C43.0 C43.10, C43.11, C43.111, C43.112, C43.12, C43.121, C43.122, C43.20, C43.21, C43.22, C43.30 C43.31 C43.39 C43.4, C43.51, C43.52, C43.59 C43.60, C43.61, C43.62, C43.70, C43.71, C43.72, C43.8 C43.9 D03.0 D03.10 D03.11, D03.111, D03.112, D03.12, D03.121, D03.122, D03.20 D03.21 D03.22 D03.30 D03.39 D03.4 D03.51 D03.52 D03.59 D03.60 D03.61 D03.62 D03.70 D03.71 D03.72 D03.8 D03.9 Z85.820) anytime from the start of data collection until the start of study period.
* Patients with a procedure of first lymph node dissection or nodal basin ultrasound surveillance, per the National Comprehensive Cancer Network (NCCN) guidelines version 2.2020. The first lymph node dissection / nodal basin ultrasound surveillance signified that the patient was eligible to receive systemic treatment as adjuvant therapy.
* The first lymph node dissection or nodal basin ultrasound surveillance (index adjuvant date) must have had a diagnosis of malignant melanoma of skin within 6 months, to ensure that the dissection was related to melanoma.
* Patients with at least pharmacy or medical claim for the study drugs within 1 year on and after index date. The index date was the date of first prescription of study drug, IO (i.e., nivolumab, ipilimumab + nivolumab, pembrolizumab) or dabrafenib + trametinib.
* At least 18 years of age at the time of adjuvant treatment initiation.
* Patients with at least 6 months of continuous enrollment prior to the index date.
* Patients with at least 6 months of continuous enrollment after the index date.

Exclusion Criteria:

* Patients with a diagnosis of non-melanoma primary malignancy (ICD-9: 140.xx-165.xx, 170.xx-171.xx, 173.xx-195.xx, 200.xx-208.xx; ICD-10: C00.x - C14.x, C41.x, C49.x, C50, C51) during the 6 months pre-index period.
* Patients with chemotherapy or interferon alpha before index date.
* Patients with pregnancy (ICD-9: 630.xx-679.xx, V22.xx-V24.xx, V27.xx-V28.xx; ICD-10: O00 - O99) any time during the study period.
Comparison of the Results of Treatment by Gamma Nail Versus Dynamic Hip Screw for Unstable Intertrochanteric Hip Fractures

The study hypothesis is the the results of the use of Gamma nail will be superior to the use of Dynamic hip screw for unstable intertrochantric hip fracture.


Eligibility Criteria:
Inclusion Criteria:

* patients diagozied with acute intertrochantric unstable fracture
* a minimum minimental score of 6
* ability to walk 500 meters indepedently

Exclusion Criteria:

* pathological fracture
* multiple fractures
* neurological conditions
Antiplatelet Therapy After Cardiac Arrest

There is growing evidence that standard dual antiplatelet therapy with acetylsalicylic acid (ASA) and clopidogrel is not as effective in the setting of therapeutic hypothermia after cardiac arrest as in normothermic patients. The reasons for this are probably slower gastrointestinal motility, absorption and liver metabolism required for clopidogrel to take action. Since ticagrelor has faster intestinal absorption and no need for liver metabolism we expect its effect to be good even in patients with therapeutic hypothermia after cardiac arrest. Patients treated with therapeutic hypothermia after cardiac arrest and percutaneous coronary intervention will be randomised into two groups. One will be treated with ASA and clopidogrel and the other with ASA and ticagrelor. Blood samples will be collected before and 2, 4, 12, 22 and 48 hours after P2Y12 inhibitor administration. Platelet function will be measured by VerifyNow P2Y12 assay and by Multiplate ADPTest. Differences between the groups will be analysed.

Hypothesis: Antiplatelet therapy with ticagrelor is more effective than therapy with clopidogrel in the comatose survivors of cardiac arrest treated with therapeutic hypothermia and percutaneous coronary intervention (PCI).


Eligibility Criteria:
Inclusion Criteria:

* Female and male over 18 years old
* Unconscious survivors of cardiac arrest treated with therapeutic hypothermia
* Acute coronary syndrome (NSTEMI or STEMI) as a reason of cardiac arrest
* PCI with stent implantation
* Provision of informed consent prior to any study specific procedures is impossible because subjects are unconscious at the moment of inclusion

Exclusion Criteria:

* Use of any P2Y12 inhibitors in last 10 days
* Use of prasugrel before and 48 hours after loading dose of P2Y12 inhibitor
* Use of eptifibatide before and 48 hours after loading dose of P2Y12 inhibitor
* Thrombocytopenia (\<50\*109/L)
* Allergic reaction to acetylsalicylic acid, clopidogrel or ticagrelor
* Ticagrelor contraindications: previous intracranial bleeding, active pathological bleeding, moderate to severe hepatic impairment, heart rate \< 40/min at presentation
* Suspected or confirmed pregnancy
* Use of bivalirudin before and 48 hours after loading dose of P2Y12 inhibitor