cyrilzakka/clinical-trials huggingface dataset:
Safety and Antiviral Activity of Clevudine in Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials

The purpose of this study is to determine safety and efficacy of clevudine 10 mg qd for 24 weeks after completion of 24-week treatment with clevudine 30 mg qd with 12 weeks follow-up period


Eligibility Criteria:
Inclusion Criteria:

1. Patient is between 18 and 60, inclusive
2. Patients who have completed L-FMAU-301 or L-FMAU-302 clinical trial.
3. Patient is HBsAg positive at week 48 in L-FMAU-301 or L-FMAU-302.
4. Patient has bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), a serum albumin level of at least 3.5 g/dL at week 48 in L-FMAU-301 or L-FMAU-302.
5. Women of childbearing potential must have a negative serum (β-HCG) pregnancy test at screening.
6. Patient is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Patients with HBV DNA \< 4,700 copies/mL, ALT normalization and consecutive e seroconversion at week 40 and 48 in L-FMAU-301
2. Patients with HBV DNA \< 4,700 copies/mL and ALT normalization in L-FMAU-302
3. Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
4. Patients previously treated with α-interferon, lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection.
5. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
6. Patient is coinfected with HCV, HDV or HIV.
7. Patient with clinical evidence of liver mass or hepatocellular carcinoma and α-Fetoprotein \> 50 ng/mL
8. Patient is pregnant or breast-feeding.
9. Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases. For males, condoms should be used. Females must be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using at least medically acceptable barrier method of contraception (i.e. IUD, barrier methods with spermicide or abstinence)
10. Patient has a clinically relevant history of abuse of alcohol or drugs.
11. Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases excluding asymptomic GB stone, neurological, cardiovascular, oncologic or allergic disease. The patient with a benign tumor except for liver mass, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
12. Patient has creatinine clearance less than 60mL/min as estimated by the following formula:

(140-age in years) (body weight \[kg\])/(72)(serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]

13.Patient whom investigator consider is not suitable in this study
DECAMP-1: Diagnosis and Surveillance of Indeterminate Pulmonary Nodules

The goal is to improve the efficiency of the diagnostic follow-up of patients with indeterminate pulmonary nodules by determining whether biomarkers for lung cancer diagnosis that are measured in minimally invasive biospecimens are able to distinguish malignant from benign pulmonary nodules that are incidentally detected in high-risk smokers.

The Detection of Early lung Cancer Among Military Personnel (DECAMP) consortium is a multidisciplinary and translational research program that includes 7 Veterans Administration Hospitals (VAH), the 4 designated Military Treatment Facilities (MTF) and 4 academic hospitals as clinical study sites, several molecular biomarker laboratories, along with Biostatics, Bioinformatics, Pathology and Biorepository cores. The DECAMP Coordinating Center will facilitate rapid selection, design and execution of clinical studies within this multi-institutional consortium. The goal will be accomplished by recruiting 500 smokers with indeterminate pulmonary nodules (0.7cm - 3.0cm) on chest CT who will undergo fiberoptic bronchoscopy and will be followed for 2 years until a final diagnosis is made. The diagnostic performance of four previously established lung cancer biomarkers in this cohort will be validated; 1) a gene-expression biomarker measured in bronchial airway brushings; 2) a proteomic signatures measured in bronchial airway biopsies; 3) a proteomic signature measured in serum; and 4) a signature of serum cytokines. The added value of the molecular markers to clinical and imaging markers routinely used in the diagnostic work up of these patients and develop an integrated model (i.e. clinical, imaging \& molecular markers) that results in the most robust diagnostic predictor will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* 45 years of age or older;
* Initial diagnosis of indeterminate pulmonary nodule (0.7-3.0 cm);
* Smoking status: Current or former smoker with ≥ 20 pack years (pack years = number of packs per day X number of years smoked)
* Willing to undergo fiberoptic bronchoscopy;
* Able to tolerate all biospecimen collection as required by protocol;
* Able to comply with standard of care follow up visits including clinical exams, diagnostic work-ups, and imaging for a minimum of two years;
* Able to fill out Patient Lung History questionnaire;
* Willing and able to provide a written informed consent.

Exclusion Criteria:

* History or previous diagnosis of lung cancer;
* Diagnosis of pure ground glass opacities on chest CT;
* Contraindications to nasal brushing or fiberoptic bronchoscopy including ulcerative nasal disease, hemodynamic instability, severe obstructive airway disease, unstable cardiac or pulmonary disease; inability to protect airway or altered level of consciousness;
* Allergies to any local anesthetic that may be used to obtain biosamples in the study.
Taste Acceptability of Tomato-Soy-Arugula Seed Beverages in Men With Prostate Cancer

This study is a sensory analysis of several different formulations of a novel tomato-soy-arugula seed beverage in men with prostate cancer. Eating a diet rich in a variety of fruits and vegetables has been associated with decreased risk of a variety of diseases, including prostate cancer. Mixed vegetable beverages may be useful in prostate cancer survivorship.

PRIMARY OBJECTIVES:

I. To evaluate the sensory acceptability of a novel tomato-soy-arugula seed beverage in men with prostate cancer.

OUTLINE:

Patients receive 4 tomato-soy beverages and 3 labeled arugula seed powder portions. Patients add 1 arugula seed powder portion to each of 3 tomato-soy beverages immediately prior to consumption and they consume 1 beverage without the powder. After each beverage tasting, patients complete a survey on the sensory acceptability of the sample.

Eligibility Criteria:
Inclusion Criteria:

* Have a prostate cancer diagnosis
* Not be allergic to tomato or tomato products
* Not be allergic to soy or soy related products
* Not be allergic to any cruciferous vegetables (e.g.: broccoli, cauliflower, kale, brussels sprouts, arugula/rocket, bok choy, etc.)
* Voluntarily agree to participate and read the informed consent documents
Platelet-rich Plasma in Calcific Tendinitis

Needle aspiration of calcific deposits (NACD ) is the treatment of choice for calcific tendinitis which does not respond to conservative treatment. NACD is effective in approximately 70% of the patients.When NACD is not effective, surgery is often the only treatment that remains.Surgery, however, is discouraged by th e Dutch guidelines for diagnosing and treating patients with subacromial pain syndrome.Therefore,both patients and the doctors treating those patients will benefit from a more effective minimal invasive treatment for calcific tendinitis.Injection of platelet-rich plasma (PRP) might, considering its positive effect on tissue repair, be a possible solution here.Previous research investigating the effects of PRP on other tendinopathies did, however, show controversial results. The aim of this double-blind randomized controlled trial is to investigate the effect of the adjuvant application of PRP after NACD on pain reduction ,recovery of shoulder function, tendon recovery,resorption of calcific deposits, the percentage of patients with persistent complaints and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 yrs
* clinical manifestions of tendinitis calcarea (pain, stifness, lock sensations, muscle atrophy)
* persistent pain sympoms \>6 months
* standardized AP x-ray shows calcific deposit of \> 5mm \& morphologic Type I \& II deposits (classification of Gärtner en Simons)
* ineffective intervention \> 2 types of conservative treatment (among which are non-steroidal anti-inflammatory drugs, physiotherapy, local anesthesia injection and/or corticosteroids, extracorporele shock wave therapy)
* indication and referral for barbotage by orthopeadic surgeon

Exclusion Criteria:

* age \> 55 years
* morphological type III deposits according to classification of Gärtner and Simons) (as indicated by standardized x-ray AP)
* bigliani type III acromion, and acromial spur of acromioclavicular osteovyt
* previous (ineffective) barbotage
* the existence of other shoulder related injuries next to calcific tendinitis (full-thickness rupture of the rotator cuff, adhesive capsulitis (frozen shoulder), arthrosis of the glenohumeral- or acromioclavicalar joint
* shoulder joint instability
* shoulder injury due to trauma or previous shoulder surgeries
* other types of disorders that could negatively influence the outcomes (rheumatic arthritis. cervical spine disorders, neurological upper extremity disorders, diabetes mellitus, infections, blood disorders, malignity, pregnancy)
* known allergic responses to one of the medications applied in the current study (lidocaine, bupivacaine, kenacort)
* usage of anti-coagulants other than ascal of plavix
Incisional Correction of Corneal Astigmatism During Phacoemulsification

Today, cataract surgery is regarded as refractive surgery, mainly aiming emmetropia, and this makes eliminating corneal astigmatism is critical. Corneal astigmatism of more than 1 diopter has been reported in up to 45% of the cataract surgery candidates.

It is possible to reduce pre-existing corneal astigmatism by creating a clear corneal incision at the steep meridian of the cornea, however; creating a small incision can correct the only astigmatism up to 1 Diopter, and sometimes this method may not be easy to perform due to the location of steep meridian like the difficulty while creating a superonasal or inferonasal incision at the left eye. This approach is usually sufficient for correcting astigmatism less than 1 D in most eyes. An opposite side clear corneal incision (OCCI) could enhance the flattening effect on the cornea.


Eligibility Criteria:
Inclusion Criteria:

* Clear cornea
* No history of previous ocular surgery
* Central corneal thickness (CCT) \<640

Exclusion Criteria:

* Irregular corneal astigmatism or lenticular astigmatism
* Corneal opacities or pathology like Fuch's endothelial dystrophy
* Previous ocular surgeries like glaucoma surgery or PKP or pterygium excision
* Posterior segment diseases and pathology
* Complicated phacoemulsification
Effects Of Prednisolone On Rheumatoid Arthritis Patients

This study will assess the Pharmacokinetic (PK) and Pharmacodynamic (PD) effects of Prednisolone on Rheumatoid Arthritis (RA) patients.


Eligibility Criteria:
Inclusion criteria:

* Meet the ACR criteria for diagnosis of rheumatoid arthritis.
* Required treatment with Prednisolone.
* Currently on a non-steroidal anti-inflammatory agent (NSAID).
* Willing to stay on current dose of NSAID for two weeks during study.

Exclusion criteria:

* Major health issues such as osteoporosis, diabetes, heart failure, heart attack, kidney failure, or acute infection.
An Extended Access Program (EAP) for Perampanel

The main objective of this EAP is to ensure that participants participating in Study E2007-G000-332, Study E2007-G000-311, E2007-G000-238, E2007-G000-338 or EAP E2007-G000-401 continue to have access to perampanel until such time that the appropriate formulation of perampanel becomes commercially available in the country in which they reside or until no participants remain in the EAP.


Eligibility Criteria:
Inclusion criteria:

1. Participants who have completed their participation in Study E2007-G000-332, Study E2007-G000-311, E2007-G000-238, E2007-G000-338, or who are being rolled over from EAP E2007-G000-401 and, who in the opinion of the treating physician, continue to demonstrate a positive benefit-to-risk ratio from treatment with perampanel.
2. Participants who provide informed consent where applicable per local requirements.
3. Female participants of childbearing potential must agree for the duration of the program and for a period of at least 1 month following last dose of perampanel to be abstinent or to commit to the consistent and correct use of a medically acceptable method of birth control (example, a double-barrier method \[condom plus spermicide, condom plus diaphragm with spermicide\]).

Exclusion criteria:

1. Participants who reside in countries where the appropriate formulation of perampanel is commercially available.
2. Female participants who are nursing, pregnant, or planning to become pregnant.
Autophagy Dysfunction in Hidradenitis Suppurativa

The pathogenesis of HS is still poorly understood: the pilosebaceous tropism and the fact that patients respond to combinations of antibiotics and/or immunosuppressive treatments suggest the involvement of 3 factors that would be intimately linked: the presence of (i) a microbial dysbiosis, (ii) a dysfunction of the pilosebaceous apparatus and (iii) an inappropriate immune response. But how these 3 elements interact with each other remains unestablished, with few studies that have analyzed them from a kinetic point of view. Beyond a possible dysfunction of the pilosebaceous apparatus, we hypothesize a bacterial dysbiosis in connection with abnormalities of autophagy function with secondary development of an inappropriate immune response. Because of its functions of bacterial clearance and activation of local immune response, a defect in the autophagic process may be associated with the development of inflammatory pathologies related to microbial dysbiosis. Crohn's disease (CD), an inflammatory pathology of the gastrointestinal tract associated with intestinal dysbiosis, has been associated with alterations in autophagy, with approximately 50% of patients having single nucleotide polymorphisms (SNPs) associated with autophagy deficiency (Ellinghaus et al., 2013). The epidemiological association of CD/HS, the presence of skin dysbiosis and a chronic inflammatory response during HS, make us suspect a deficit of autophagic function in these patients, in a similar way to what is observed during Crohn's disease.

The aim of this study is to analyze the frequency of 100 SNPs, reported to be associated with autophagy deficiency, in a cohort of moderate-to-severe HS patients.


Eligibility Criteria:
Inclusion Criteria:

* Subject aged 18 to 65 years (included)
* Subject diagnosed with HS for at least 1 year
* Subject diagnosed with moderate-to-severe HS defined by HS PGA≥3
* Subject presenting an HS with inflammatory phenotype defined by the presence of folliculitis, nodules and/or abcesses
* Subject suffering from at least 4 flares/year and presenting 5 active inflammatory lesions (nodules and/or abcesses)
* Subject able to read, understand and give documented informed consent
* Subject willing and able to comply with the protocol requirements for the duration of the study
* Subject with health insurance coverage according to local regulations

Exclusion Criteria:

* - Pregnancy or breast-feeding women
* Subject currently experiencing or having a history of other concomitant skin or systemic inflammatory conditions that could constitute a bias (i.e. psoriasis, Crohn's Disease, etc.)
* Subject with any additional condition that, in the opinion of the investigator, may interfere with the assessment or put the subject at risk
* Linguistic or mentally incapacity to sign the consent form
* Subject protect by the law (adult under guardianship, or hospitalized in a public or private institution for a reason other than study, or incarcerated)
* Subject in an exclusion period from a previous study or who is participating in another clinical trial using a drug
Nd:YAG Laser Versus Diode Laser Assisted New Attachment Procedure (Lanap) in the Management of Stage II Periodontitis

Aim of the study was to assess and compare the clinical and microbiological changes following Laser assisted new attachment procedure (LANAP®) using diode 940 nm versus ND:YAG 1064 nm, and to compare the outcome to conventional periodontal therapy


Eligibility Criteria:
Inclusion Criteria:

* Periodontal diagnosis of stage II periodontitis.
* Residual periodontal pocket ≥4 mm, 3-4 mm clinical attachment loss with horizontal bone loss higher than 15% in radiography.
* O'Leary plaque index \<10%.

Exclusion Criteria:

* Patients with furcation involvement.
* Class II/III tooth mobility.
* Smokers who smoke more than 10 cigarettes per day.
* Patients with any systemic condition possibly affecting the outcome of periodontal therapy.
* Patients who had received any local or systemic anti-inflammatory medications or antibiotics within the last 6 months.
* Alcohol consumers.
* Pregnant or lactating women.
* Patients with parafunctional habits.
Osseotite Certain Prevail for the Preservation of Crestal Bone

A potential complicating factor affecting implants is crestal bone loss. The causes of crestal bone loss are attributed to several factors. Among those hypothesized, proof for one or another cause remains obscure. Clinical documentation suggests that implant design may be a key factor. While the evidence is inconclusive, various authors suggest that it is a result of a combination of effects including (1) limited drilling procedure and restricted second-stage surgery 2, (2) rough implant surface in crestal bone 3, (3) microthread design for implant stiffness 4, (4) loading along a conus versus a flat interface 5, and (5) the absence of a significant microgap 6.

The practice of platform switching (e.g. placing a 4 mm diameter abutment on a 5 mm implant seating surface physically moves the inflammatory cell infiltrate zone away from the crestal bone). The growing body of anecdotal platform switch evidence supports this biological width hypothesis. Here the biological width refers to the height of the dento-gingival attachment apparatus around a normal tooth and is defined as the distance necessary for a healthy existence of bone and soft tissue from the most apical extent of a dental restoration.

To formally test this hypothesis the current study has been designed. The Prevail implant has been made with an integrated medialized seating surface that establishes a platform switching function. This implant moves the implant/abutment interface away from the crestal bone and may therefore reduce the amount of bone loss observed in the standard (non-medialized) Osseotite implant design. The objective of this study is to evaluate crestal bone levels adjacent to the implant reference point from the time of implant placement to a period of two years after loading.


Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex and any race greater than 18 years of age
* Patients for whom a decision has already been made to use dental implants for the restoration of existing edentulism in the mandible or maxilla.
* Patients must be physically able to tolerate conventional surgical and restorative procedures.
* Patients must agree to be evaluated for each study visit, especially the yearly follow-up visits.

Exclusion Criteria:

* Patients with active infection or severe inflammation in the areas intended for implant placement.
* Patients with a \> 10 cigarette per day smoking habit.
* Patients with uncontrolled diabetes mellitus.
* Patients with uncontrolled metabolic bone disease where there is a diagnosis of the following: Osteomalacia, primary or secondary hyperparathyroidism, renal osteodystrophy, or Paget's disease of bone.
* Patients with a history of therapeutic radiation to the head
* Patients in need of bone grafting at the site of the intended study implant for augmentation purposes.
* Patients who are known to be pregnant at the screening visit.
* Patients with evidence of severe para-functional habits such as bruxing or clenching
Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide 100 mg /25 mg Tablet Under Fed Conditions

The objective of this study was to prove the bioequivalence of losartan potassium/hydrochlorothiazide 100/25 mg tablet under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to losartan potassium hydrochlorothiazide or any comparable or similar product.
A Pilot Study to Explore the Role of Gut Flora in Crohn's Disease

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Crohn's disease.

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Crohn's disease.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients age 12 and older. (interest is given to children 12 and older to compare with mothers).
3. Diagnosis of Non-Fistulating Crohn's disease confirmed by at least one of the following

   1. Colonoscopy
   2. Capsule Endoscopy
   3. Computerized Tomography (CT) Scan
   4. Magnetic Resonance Imaging (MRI)
   5. Balloon-assisted enteroscopy

Exclusion Criteria:

1. Refusal to sign informed consent form
2. Presence of Fistulating Crohn's disease
3. Treatment with antibiotics within 2 weeks prior to screening
4. Treatment with probiotics within 6 weeks prior to screening.
5. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
6. Postoperative stoma, ostomy, or ileoanal pouch
7. Participation in any experimental drug protocol within the past 12 weeks
8. Treatment with total parenteral nutrition
9. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
10. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study