cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PF-04958242 in Healthy Adult Volunteers

The primary objective of this study evaluates the safety and tolerability of multiple, escalating doses of PF-04958242 administered orally to healthy adult participants.This study also evaluates the plasma and urine multiple dose pharmacokinetics (PK) of PF-04958242.

A decision was made to terminate the B1701002 study so that emerging data from the study and from a preclinical study in rats could be further examined and incorporated into a new study design and protocol.

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Key Inclusion Criteria:

* Body Mass Index (BMI) of 17.5 to 30.5 kilograms per meter quared (kg/m2);
* Total body weight \>50 kilograms (kg) (110 pounds \[lbs\]);

Key Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing);
* Positive urine drug screen;
* Pregnant or nursing females, and females of child bearing potential;
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Autograft Versus Calcium Phosphate Macroporous Bioceramics as Bone Substitute for Tibial Valgus Osteotomy

The aim of the study is to compare radiological behavior of blocks of macroporous phosphocalcium as bone substitute in comparison with iliac crest autograft in tibial valgus osteotomy.


Eligibility Criteria:
Inclusion Criteria:

* knee osteoarthritis eligible for tibial valgus osteotomy
* \> 18 y.o

Exclusion Criteria:

* prior tibial osteotomy
* history of local infection
* rheumatoid and other inflammatory arthritis
Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis

This is a phase III trial to determine whether adjunctive sertraline will lead to improved survival 18-week survival.

There was an initial phase I/II unmasked dose finding pharmacokinetic study of CSF concentrations in 172 persons conducted from August 2013 to August 2014. See NCT03002012.

This is a phase III randomized trial to evaluate whether sertraline when added to standard amphotericin-based therapy for cryptococcal meningitis, will lead to improved survival . Cryptococcal meningitis diagnosis will be made via CSF cryptococcal antigen (CRAG) at time of lumbar puncture (LP) with confirmation by CSF culture. After informed consent, subjects that meet eligibility requirements will be able to enter study. A non-randomized phase I dose-escalation study will first be conducted to help optimize dosing for a larger randomized phase II study.

Phase III Design: Subjects will be randomized to standard induction therapy with masked placebo or sertraline at 400mg/day. We will use a permutated block randomization in a 1:1 allocation (n=275 per arm). Total anticipated enrollment: 550 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Cryptococcal meningitis diagnosed by CSF cryptococcal antigen (CRAG)
* HIV-1 infection
* Ability and willingness of the participant or legal guardian/representative to provide informed consent
* Willing to receive protocol-specified lumbar punctures

Exclusion Criteria:

* Age \< 18 years
* Receipt of \>=3 doses of amphotericin therapy
* Cannot or unlikely to attend regular clinic visits
* History of known liver cirrhosis
* Presence of jaundice
* Pregnancy
* Current breastfeeding
Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation

This study is a 2-armed parallel, multi-centered, pragmatic clinical trial that compares the comparative effectiveness of non-pharmacological treatment and pharmacological treatment for non-acute lumbar disc herniation.

This study is a multi-centered, pragmatic clinical trial that compares the comparative effectiveness of non-pharmacological treatment and pharmacological treatment for non-acute lumbar disc herniation. The participants who voluntarily signed informed consent will be randomly assigned in 1:2 ratio to non-pharmacological group and pharmacological group and will receive the 8 weeks of intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Numeric rating scale (NRS) score of radiating pain or low back pain 5 or more for recent 3 serial days.
2. Onset time of radiating pain occurred 3 months before enrollment.
3. Radiologically diagnosed with lumbar disc herniation in lumbar spine magnetic resonance imaging (L-spine MRI), which can explain lower extremity radiation pain and back pain
4. 19-69 years old
5. participants who agreed and signed informed consent form

Exclusion Criteria:

1. Spine metastasis of cancer, acute fracture of spine, or spine dislocation
2. Progressive neurologic deficits or severe neurologic deficits
3. Soft tissue diseases that can induce low back pain(ie. cancer, fibromyalgia, rheumatoid arthritis, gout,etc)
4. Presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc)
5. Concurrent use of steroids, immunosuppressants, orpsychotropic medications or any other medication that can interrupt the study result
6. Hemorrhagic disease, severe diabetes or taking anticoagulant drug
7. Participants who took NSAIDs within 1 week
8. Pregnant or lactating women
9. Participants who had undergone lumbar surgery within 3 months
10. Participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial during follow up period of this trial
11. Participants who can not write informed consent
12. Participants who is difficult to participate in the trial according to investigator's decision
Trimodal (18)F-choline-PET/mpMRI/TRUS Targeted Prostate Biopsies

Prostate cancer is the first cancer in humans (25%). The most widely used tracer in oncology, the 18-Fluoro DeoxyGlucose does not allow the study of prostatic neoplasia. On the other hand, Choline, which is an amino alcohol, is involved in the synthesis of cell membranes and has an affinity for prostate cells. Its concentration is directly proportional to cell proliferation. The analogue of choline has the advantage of having a rapid and stable accumulation over time in cancer cells, with a rapid urinary excretion (4 minutes after injection).

The goal of this study is to assess the feasibility and the accuracy for targeting image guided prostate biopsy to detect prostate cancer after Imaging fusion of choline-PET/CT compared to 1.5T multiparametric magnetic resonance imaging (mpMRI) with 3D-transrectal ultrasound (TRUS) .


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspicion of prostate cancer
* Patients who performed prostate mpMRI and F-Choline 18 PET scan
* Patient capable of receiving clear informations
* Patient giving a written consent for their participation via a consent signed by both parents of the patient (or legal tutor)
* Patient covered by a healthcare insurance

Exclusion Criteria:

* Patients without suspect image of neoplasia after mpMRI and F-Choline 18 PET scan
Biomarkers, Neurodevelopment and Preterm Infants

Approximately 2% of neonates in the US are born very preterm. Preterm births are associated with impaired cognitive, language and motor function, and increased risk for autism spectrum disorders. Epidemiological studies indicate a dose-response relationship between gestational age at delivery and cognitive impairments, with the most immature of newborns being the most susceptible to developmental delays. Sensitive and reproducible biomarkers of long-term neurocognitive impairments are currently lacking. The investigators seek to identify epigenetic markers that mediate the relationship between adverse prematurity-related exposures and neurocognitive impairments. The overarching hypothesis of this proposal is that DNA methylation profiles of CD34+ hematopoetic progenitor and stem cells from very preterm infants can be used as a risk-stratifying biomarker for predicting neurocognitive impairment in childhood.


Eligibility Criteria:
Inclusion Criteria:

* \<32 weeks" gestation
* Born at Weiler Division of Montefiore

Exclusion Criteria:

* Intraventricular hemorrhage
* Chromosomal abnormalities
* Congenital viral conditions
All-poly Versus Metal-backed

The primary objective is the assessment of prosthetic migration results after two years of the Triathlon PS Knee System with all-polyethylene tibial components compared to the Triathlon PS Knee System with metal-backed modular components by means of Roentgen Stereophotogrammetry.

The secondary objective will be the prediction of the long-term survival based on the two-year migration patterns combined with clinical factors and radiographic aspects. In order to identify other clinical parameters besides the fixation of the prosthesis components, clinical scores and radiographic aspects will be correlated with the RSA outcome.

Eligibility Criteria:
1. The subject is morbidly obese, defined as Body Mass Index (BMI) of \> 40. 2. Patient has a flexion contracture of 15° and more. 3. Patient has a varus/valgus contracture of 15° and more. 4. Patients with a pre-operative knee score of \>70. 5. The subject has a history of total or unicompartmental reconstruction of the affected joint. 6. The subject will be operated bilaterally. 7. Patients who had a Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA \> 1 year ago with good outcome can be included in the study). 8. Patients who had a Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA \> 6 months ago with good outcome can be included in the study). 9. The subject has an active or suspected latent infection in or about the knee joint. 10. Osteomyelitis 11. Sepsis 12. Patient who is expected to need lower limb joint replacement for another joint within one year. 13. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. 14. The subject has a systemic or metabolic disorder leading to progressive bone deterioration. 15. The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements. 16. The subject's bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. 17. The subject has had a knee fusion to the affected joint. 18. Female patients planning a pregnancy during the course of the study. 19. The patient is unable or unwilling to sign the Informed Consent specific to this study
Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1:FOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC (MARAVI-PEP)

As a measure of secondary prophylaxis, and with the final objective of avoiding the infection, it has been suggested to use antiretroviral therapy. This is known as post-exposure prophylaxis (PEP).

Although there are different recommendations, almost every guideline recommend using 3 drugs as PEP both in USA and Europe.

Toxicity is one of the main limitations of PEP. Side effects during PEP are very usual, are attributed mainly to PI and are the main reasons for poor adherence or lost of follow-up.

A current standard regimen is AZT+3TC (Combivir®) or tenofovir+emtricitabine (Truvada®) plus the PI lopinavir/r. Toxicity associated with this regimens are high (31-85% of cases), with a 10-35% interruption of PEP Maraviroc, a CCR5 receptor antagonist, very well tolerated, coul be an adequate drug for PEP.


Eligibility Criteria:
Inclusion Criteria:

* Both sexes
* Older than 18 years old
* A potentially sexual exposition to HIV
* Accept to participate

Exclusion Criteria:

* Pregnant women
* The source case a person with HIV antiretroviral resistances
* Persons with a treatment that is contraindicated with the drugs in the study
Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [Pf-01913539] In Subjects With Hepatic Impairment And Normal Hepatic Function

1. To compare the pharmacokinetics of Dimebon in subjects with mild and moderate hepatic impairment to subjects with normal hepatic function.
2. To assess the safety and tolerability of Dimebon in subjects with hepatic impairment and subjects with normal hepatic function.
3. To explore the pharmacokinetics of Dimebon in subjects with severely-impaired hepatic function.


Eligibility Criteria:
Inclusion Criteria:

* Healthy (healthy is defined as the absence of clinically-relevant abnormalities identified by a detailed medical history, full physical examination, 12-lead ECG and clinical laboratory tests).
* Free of any medical or surgical conditions that might significantly interfere with gastrointestinal absorption, distribution, metabolism, or excretion of Dimebon.
* Demographically comparable to subjects with mild and moderate hepatic impairment.
* Subjects with hepatic impairment: Screening medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests performed within 28 days before the first dose of study medication, abnormal findings that are related to the subject's underlying condition are acceptable.
* Satisfy the criteria for Class A, B, or C of the modified Child-Pugh classification \[Mild (Child-Pugh Scores 5-6 points), moderate (Child-Pugh Scores 7-9 points), and severe (Child-Pugh Scores \>9 and \<12 points)\] within 14 days before the first dose of study medication.
* A diagnosis of hepatic impairment due to cirrhosis, not secondary to other diseases, which is confirmed and documented by medical history, physical examination, liver biopsy or hepatic ultrasound, CT scan or MRI.

Exclusion Criteria:

* Subjects presenting with any of the following will not be included in the trial:CYP2D6 PM genotype, as identified by screening genotyping.
* A known sensitivity to Dimebon.
* Exposure within the previous three months to a drug known to have a negative effect on skeletal muscle or reproductive organs.
* History of febrile illness within 5 days prior to the first dose.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, active peptic ulcer within last 3 months).
Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty

The purpose of this research is to collect data on patients that had the Legion Porous HA Tibial Baseplates and/or the Legion Porous HA Femoral component implanted in the past. Smith \& Nephew will evaluate the safety and performance of these implants for 10 years post-surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Subject received primary TKA with the LEGION Porous HA Tibial Baseplates (either with holes or without holes) and/or the LEGION Porous HA CR Femoral Component, due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, or degenerative arthritis).
2. Subject received primary TKA between 24 and 60 months prior to the time of consent.

   Inclusion criteria for prospective follow-up (subjects must meet criteria 1 \& 2 from above and criteria 3,4 and 5 below):
3. Subject agrees to consent and to follow the prospective study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/IEC approved informed consent form.
4. Subject must be available through ten (10) years postoperative follow-up.
5. Subject is able to read, understand, and communicate responses to Patient Reported Outcome assessments in English.

Exclusion Criteria:

Exclusion criteria for retrospective chart review - Any one (1) of the following criteria will disqualify a potential subject from participation in the retrospective chart review:

1. Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty
2. Subject has ipsilateral hip arthritis resulting in flexion contracture.
3. At the time of enrollment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator: Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty; Contralateral primary total knee or unicondylar knee arthroplasty.
4. Subject has a condition that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, lupus, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).
5. Subject has a known allergy to one or more of its components of the study device.
6. Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days.

   Exclusion criteria for prospective follow-up - Any one (1) of the criteria from 1-6 above will disqualify a potential subject from participation in the prospective follow-up) as will any one (1) of the below criteria 7, 8 and 9:
7. Subject, in the opinion of the Principal Investigator (PI), has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
8. Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.
9. Subject is found to have had a revision of the study device(s).
A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development

This study will monitor patients during the first year following their stroke.

Stroke is a very serious condition where there is a sudden interruption of blood flow in the brain.

The main aim of the study will be to find out how many of those who experience their first-ever stroke then go on to develop spasticity that would benefit from treatment with medication.

Spasticity is a common post-stroke condition that causes stiff or ridged muscles.

The results of this study will provide a standard guideline on the best way to monitor the development of post-stroke spasticity.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be aged 18 to 90 years at the time of providing informed consent
* First-ever clinical stroke, defined according to World Health Organization criteria as rapidly developing clinical signs of focal (at times global) disturbance of cerebral function lasting more than 24 hours, within the past 4 weeks;
* Confirmed paresis of the arms and/or legs which does not resolve within 1 day, according to the NIHSS score (a score of \> 0 on Question 5 or 6 of the scale) between Day 3 and day 14 after the stroke
* Capable of giving informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

Exclusion Criteria:

* Upper or lower extremity functional impairment prior to stroke per investigator judgement (e.g., modified Rankin Scale \>2);
* Presence of significant/major neurological impairment that might affect muscle tone (other than limb paresis);
* Severe multi-impairment or diminished physical condition before stroke that could have caused paresis/spasticity/motor deficit per investigator judgement;
* Life expectancy of less than 12 months as a result of severity of stroke or other illnesses (e.g. cardiac disease, malignancy, etc.)
* Participation in any interventional study
Safety and Effectiveness of VYC-12 Hyaluronic Acid Injectable Gel for Treatment of Superficial Cutaneous Depressions

This study will evaluate the safety and effectiveness of VYC-12 hyaluronic acid (HA) injectable gel for filling fine lines, as measured by skin texture improvement, and for improvement of skin quality.


Eligibility Criteria:
Inclusion Criteria:

* Participants in good general health
* Score of 2=Moderate (coarse and uneven visual skin texture) or 3=Severe (coarse visual skin texture, crosshatched fine lines) on both cheeks using the 5-Point Allergan Skin Roughness Scale (ASRS).

Exclusion Criteria:

* Has undergone tissue augmentation with dermal fillers including HA, calcium hydroxylapatite, autologous fat, mesotherapy, or other cosmetic procedures (eg. face-lift, laser, photomodulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative procedures) in the face or neck within the past 12 months
* Has received any crosslinked HA filler in any anatomic area within the past 12 months
* Has undergone treatment with botulinum toxins in the face or neck within the past 6 months
* Has ever received semi-permanent fillers or permanent facial implants (eg. poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene) anywhere in the face or neck
* Has facial hair that would interfere with the visualization of the face or neck
* Has undergone a dental procedure within the past 6 weeks
* Has a tendency to develop hypertrophic scarring
* Has a history of allergy to HA products and/or to gram-positive bacterial proteins as HA is produced by Streptococcus-type bacteria
* Has a history of anaphylactic shock
* Has been previously diagnosed with streptococcal disease (eg. recurrent sore throat, acute rheumatic fever)
* Has current cutaneous inflammatory or infectious processes (eg. acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion on the face or neck
* Is on an ongoing regimen of anticoagulation therapy (eg. warfarin)
* Is on an ongoing regimen of medications (eg. aspirin, ibuprofen) or other substances (eg, herbal supplements with garlic, gingko biloba, or ginseng) known to increase coagulation time within 10 days of undergoing study device injection
* Has begun using any over-the-counter or prescription, oral or topical, antiwrinkle products on the face or neck within the past 30 days.
Supersaturation and Precipitation of Diclofenac in the Stomach of Healthy Volunteers

Investigate the supersaturation and precipitation behaviour of diclofenac in the stomach of healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Age 20 - 35 years

Exclusion Criteria:

* Illness
* Acute / Chronic gastric disorder
* Use of medicine
* (possible) pregnancy
* Frequent exposure to X-rays during the past year
* HIV / Hepatitis B Virus or Hepatitis C Virus infection
Effect of Extraneal (Icodextrin)on Triglyceride Levels in PD Patients

This is a Phase IV study evaluating triglyceride levels in peritoneal dialysis patients.

This prospective, open label, multi-center study evaluates the use of 7.5% icodextrin used in the long-dwell exchange in peritoneal dialysis patients with elevated triglyceride levels. Fasting triglyceride levels will be measured during the study.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* CAPD/APD on dialysis for at least 3 months
* Elevated fasting triglyceride levels

Exclusion Criteria:

* enrolled in another study requiring IRB approval
* allergy to starch-based polymers
* glycogen storage disease
* maltose or isomaltose intolerance
* active alcohol/substance abuse
* Pregnant or nursing
* received an investigational drug within 30 days of screening