cyrilzakka/clinical-trials huggingface dataset:
Registry to Measure the Impact of Adding Genomic Testing

This is a prospective open registry to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer. Physicians will complete a series of questionnaires. Biopsy tissue will be tested using the Prolaris® genomic test and a relative cancer aggressiveness score will be shared with the physician and the patient.

This is a prospective open registry to measure the impact on first-line therapy of genomic testing of biopsy tissue from recently diagnosed treatment-naïve patients with early stage localized prostate cancer . Physicians, using standard clinical-pathological parameters (PSA, Gleason score, clinical stage and percent positive cores), will complete a questionnaire that will record their recommendation for first-line therapy from among various treatment options. A sample of the biopsy tissue will then be tested using the Prolaris® genomic test and a relative cancer aggressiveness score will be shared with the physician. After reviewing and considering the results of the genomic testing but prior to the patient consult, the physician will then complete a second treatment decision questionnaire and VAS again. The physician will then discuss the recommended treatment plan with the patient and record the agreed treatment plan on a third questionnaire. After the initial treatment has been initiated, the physician or research staff will record the actual treatment administered in the fourth questionnaire (preferably recorded within 3 months of the patient consultation).

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed (\< or equal to 12 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics:
* PSA less than or equal to 10 ng/dl and
* Gleason's 7 (4+3 or 3+4) or Gleason's 6 and
* Age greater than 55 years old and
* Clinical Stage T1 or T2
* Clinically localized (no evidence on clinical or imaging studies of advanced disease).
* No hormonal therapy including luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, anti-androgen, estrogens or exogenous androgens, when applicable.

Exclusion Criteria:

- Known history of hypogonadism
A Trial of Hydrus Microstent Versus Goniotomy

The goal of this clinical trial is to evaluate the comparative efficacy and safety of Hydrus Microstent, incisional goniotomy, and excisional goniotomy when combined with cataract surgery in patients with mild and moderate open-angle glaucoma. The main questions it aims to answer are:

* How do the intraocular pressure lowering effects of these three microinvasive glaucoma surgeries compare?
* How do the safety profiles of these three microinvasive glaucoma surgeries compare?

Participants will be randomized to one of these three microinvasive glaucoma surgeries in combination with cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Visually significant cataract planned for surgery
* Mild to moderate open-angle glaucoma, including pigmentary glaucoma and pseudoexfoliation glaucoma
* Mild stage glaucoma includes glaucomatous optic neuropathy and visual field mean deviation better than -6.0 dB, with no points in the central 5 degrees \<15 dB
* Moderate stage glaucoma includes: 1) glaucomatous optic neuropathy and visual field mean deviation equal to or worse than -6.0 dB but no worse than -12.0 dB and no central 5 degree points \<15 dB or 2) mean deviation -12.0 dB or better with 1 central 5 degree point \<15 dB
* Medicated IOP between 10 to 31 mm Hg, inclusive, at time of decision for surgery
* Willing and able to understand and provide informed consent
* Willing and able to attend postoperative examinations per protocol schedule

Exclusion Criteria:

* Prior argon laser trabeculoplasty, laser peripheral iridotomy, incisional glaucoma surgery, or cyclophotocoagulation
* Selective laser trabeculoplasty within 90 days of study enrollment
* Iridotrabecular contact for 180 degrees or greater
* Peripheral anterior synechiae in nasal or inferior angle
* Best corrected visual acuity worse than 20/200
* Phacodonesis on pre-operative examination
* Vitreous in anterior chamber on pre-operative examination
* Nanophthalmos
* Anti-platelet and anticoagulant medications other than aspirin 81mg daily
* Active treatment for another ophthalmic condition in either eye (e.g., anti-VEGF injections, steroids for corneal transplant)
* Abnormality in study eye that could affect tonometry
* Glaucoma diagnosis other than the above
* Normal tension glaucoma
* Conditions that can cause elevated episcleral venous pressure (e.g., Sturge-Weber syndrome, Graves disease, retrobulbar tumor)
* History of uveitis in either eye
* Inability to complete gonioscopy examination
* Use of oral steroids within 90 days or anticipated use of oral steroids
* Oral medications that can affect IOP, including oral carbonic anhydrase inhibitors such as acetazolamide and methazolamide
* History of steroid-associated IOP elevation
* Medically unfit for attending planned study visits
* Involvement in another interventional research study
Lung Volume Reduction Coil Treatment in Emphysema.

* BACKGROUND: Medical therapeutic options for the treatment of emphysema remain limited. Lung volume reduction surgery is infrequently used because of its high morbi-mortality. Endobronchial lung volume reduction coil (LVRC(®), PneumRx, Mountain View, CA) treatment has been recently developed and has been shown to be feasible and associated with an acceptable safety profile, while resulting in improvements in dyspnea, exercise capacity and lung function. The objective of this study is to analyze the cost effectiveness of LVRC treatment in severe emphysema.
* METHODS:This prospective, multicenter study, randomized with a 1:1 ratio (LVRC vs conventional treatment) will include 100 patients who will be followed up for 1year. The primary outcome measure is the 6-month improvement of the 6-minute walk test: the percentage of patients showing an improvement of at least 54m will be compared between groups. A cost-effectiveness study will estimate the cost of LVRC treatment, the global cost of this therapeutic option and will compare the cost between patients treated by LVRC and by medical treatment alone.
* EXPECTED RESULTS:This study should allow validating the clinical efficacy of LVRC in severe emphysema. The cost-effectiveness study will assess the medical-economic impact of the LVRC therapeutic option.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral emphysema on Chest CT Scanner
* Post bronchodilator FEV1 \< 50 %
* Total Lung Capacity \> 100 %
* Residual Volume \> 220 %
* Dyspnea score between 2 and 4 based on the mMRC scale
* Stopped cigarette smoking for more than 8 weeks
* Pulmonary rehabilitation within the previous twelve months
* Consent form signed
* Covered by Medical Insurance

Exclusion Criteria:

* Post bronchodilator FEV1 \< 15%
* Post-bronchodilator change in FEV1 \> 20%
* Severe recurrent respiratory infections requiring more than 2 hospitalization stays within the past twelve months
* COPD exacerbation requiring hospital stay within 3 months
* Pulmonary Hypertension (Pulmonary systolic pressure \>50 mmHg on cardiac echo)
* Patient unable to perform a 6-min walking test in room air
* Giant bulla of more than 1/3 of the lung field on Chest CT
* Strictly homogeneous emphysema on Chest CT
* Clinically significant bronchiectasis
* Past history of lobectomy, lung volume reduction surgery, lung transplantation
* Any extrapulmonary diseases compromising survival or evaluation within the protocol (severe cardiac disease, severe renal insufficiency, cancer...)
* Lung carcinoma or pulmonary nodule on CT scan requiring Chest CT scan follow-up
* Contra-indication to general anesthesia
* Oral anticoagulant treatment (antivitamin K)
* Allergy to nitinol
* Inclusion in an other study assessing respiratory treatments
* Patient protected by the law
A Long Term Follow-up Study in Participants Treated in a Preceding Phase 2 or 3 Study With a Regimen Containing Odalasvir and AL-335 With or Without Simeprevir for the Treatment of Hepatitis C Virus (HCV) Infection

The main purpose of this study is to evaluate the durability of Sustained virologic response (SVR) in participants who achieved SVR at last post-therapy visit of parent studies (LPVPS) with NCT Numbers NCT02569710 and NCT02765490.

This multicentre study will not provide any study treatment but collect follow-up data for up to 3 years to assess the long term durability of SVR achieved in one of the parent studies \[phase 2 or 3 with AL-335 and Odalasvir (ODV) with or without Simeprevir (SMV\]. In addition participants who failed to achieve an SVR in the parent study can be enrolled to assess the presence of resistance associated substitutions (RAS) and their persistance over time. It is expected that the vast majority of approximately 250 participants will enrolled in the study. Safety parameters and Liver disease status will be assessed in all participants over time.

Eligibility Criteria:
Inclusion Criteria:

* Participant was randomized to a regimen containing Odalasvir (ODV) with AL-335 with or without Simeprevir in a preceding Phase 2 or Phase 3 study (parent study)
* Participant received at least 1 dose of ODV with AL-335 with or without SMV in the parent study
* Participant has completed the last post-therapy follow-up visit of the parent study ( LPVPS) and has not passed the screening period of 6 + 3 months after the LPVPS
* Participant has signed an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study

Exclusion Criteria:

* Participant is currently enrolled or plans to enroll in another study with an investigational drug (including investigational vaccines) or an invasive investigational medical device between the LPVPS and Visit 6 of the present study (36 months (+/-) 4 weeks after the LPVPS of the parent study)
* Participant received antiviral or immunomodulating treatment, including therapeutic vaccines, for HCV infection between the LPVPS and the screening visit of the present study, or is planned to receive such treatment during the period of this follow-up study
* Participant is not able to adhere to the requirements of the follow-up study
Impact of Humira® Therapy on Ocular Inflammation, Selected Health Care Resource Utilization and Patient Reported Outcomes in Patients With Active Non-infectious Intermediate, Posterior and Panuveitis in Routine Clinical Practice

This study aims at evaluating real life effectiveness of originator adalimumab (Humira®) participants with active non-infectious intermediate, posterior and panuveitis (NIIPPU) despite high-dose corticosteroid therapy; including effect on ocular inflammation, health-related quality of life, health resource utilization, work ability and medication burden, as well as describe the characteristics of NIIPPU participants treated with Humira® in the real-life setting.


Eligibility Criteria:
Inclusion Criteria:

* Participants voluntarily signed a patient authorization form to use and disclose personal health information (or informed consent, where applicable).
* Age \>= 18 years at the time of the enrollment.
* Diagnosis of active NIIPP uveitis as defined by the presence of at least 1 of the following parameters:

  1. Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
  2. \>= 2+ anterior chamber cells \[Standardization of Uveitis Nomenclature (SUN) criteria\]
  3. \>= 2+ vitreous haze \[National Eye Institute (NEI)/SUN criteria\]
* Humira® treatment is indicated as per local Summary of Product Characteristics (SmPC) and professional and/or reimbursement guidelines.
* Decision on the treatment with Humira® was made prior to any decision to approach the patient to participate in this study.

Exclusion Criteria:

* Participants who cannot be treated with Humira® according to the local Humira® SmPC and/or local professional and reimbursement guidelines.
* Prior treatment with Humira®, including current course of Humira® started prior to baseline visit assessments.
* Participants currently participating in other clinical research.
* Participants who are unwilling or unable to complete the quality of life and other patient reported questionnaires.
TBI Project Amsterdam

Traumatic Brain Injury (TBI) is the world leading cause of acquired brain injury. Literature suggests a pivotal role for attentional functioning in neurocognitive and behavioural consequences of paediatric TBI. Limitations of traditional neuropsychological measures of attentional functioning have interfered with identification of the effect of paediatric TBI on attentional networks so far. Moreover, the associations between attentional networks, learning abilities, academic performance and behavioural and emotional problems following paediatric TBI are yet to be explored.

Background:

Traumatic brain injury (TBI) is the world leading cause of disability in children (Winslade, 1998), causing deficits in motor function, neurocognition and adaptive behaviour (Anderson, 2001). Literature shows that age at injury is inversely related to the magnitude of deficits following TBI, highlighting the vulnerability of children for the effects of TBI.

The neurocognitive consequences of paediatric TBI have primarily been characterized by impairments in speed of information processing, attentional functioning and learning (Babikian \& Asarnow, 2009; Catroppa \& Anderson, 2009), interfering with typical neurocognitive development. We aim at elucidating the effects of TBI on neurocognitive function and investigate the relations between neurocognitive deficits, academic achievement and emotional and behavioural function, in order to improve our understanding of the post-injury functioning of children that have suffered TBI.

Methods:

Patients with TBI will be compared to a control group consisting of orthopedically injured patients. Orthopaedic control (OC) groups offer a better comparison to TBI patients than typically developing children by controlling for TBI risk factors related to neurocognition (e.g. Attention Deficit Hyperactivity Disorder, socioeconomic status), hospitalisation and the type of injuries other than brain injuries.

Measures:

Child's Orientation and Amnesia Test, Attention Network Test, Probabilistic Learning Test, Child Behaviour Checklist, Strengths \& Difficulties Questionnaire, Experimental Neurocognitive Test developed at the VU University and Pupil Monitoring System.

Eligibility Criteria:
Inclusion Criteria:

TBI patients will be included if they

* have parental written informed consent
* provide written informed consent if aged over 11 years
* are Dutch speaking
* have a clinical diagnosis of TBI (closed head injury)
* have a time post-injury that is longer than 1 month
* are aged between 6-12 years.

Trauma control patients will be included if they:

* have parental written informed consent
* provide written consent if aged over 11 years
* are Dutch speaking
* have suffered an orthopaedic injury
* have no history of TBI
* and are aged between 6-12 years.
Preemptive Analgesia of Gabapentoids in Orthopedic Surgery

To address the preemptive analgesic effect of preoperative gabapentoids versus no gabapentoids in orthopedic surgery

Computer search for all studies used preoperative gabapentoids versus no gabapentoids in orthopedic surgery during the last 10 years (from 2011 - 2020)

Eligibility Criteria:
Inclusion Criteria:

* RCT, during last 10 years, involving orthopedic surgery

Exclusion Criteria:

* non randomized trials, unavailable study data
Evaluating of the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The purpose was the evaluation of efficacy and safety of 10 mg oral Vardenafil in Nigerian subjects with Erectile Dysfunction (ED).


Eligibility Criteria:
Inclusion Criteria:

* Men \>/= 18 years of age
* Erectile Dysfunction

Exclusion Criteria:

* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy
* Other exclusion criteria apply according to the Summary of Product Characteristics
Qualitative Validation of Patient-Reported Outcomes (PRO) Instrument

The purpose of this study is to conduct concept elicitation and cognitive debriefing interviews with patients who have been implanted with the KAMRA inlay in order to assess the content validity of a PRO instrument


Eligibility Criteria:
Inclusion Criteria:

1. Minimum 45 years of age, maximum age 60 years;
2. Subject has been implanted with the KAMRA inlay;
3. Subject is in good general health, as evidenced by medical history;
4. Subject is willing and able to attend and participate in the interviews and demographic questionnaire (fluent in U.S. English); and
5. Signed informed consent document.

Exclusion Criteria:

1. Subject has severe neurological or cognitive deficits or an uncontrolled psychiatric condition that might affect their ability to participate in the interview;
2. Subject has insufficient ability to read or write that would prevent them from completing a questionnaire without help;
3. Subject is not a fluent speaker of U.S. English; or
4. Subject is unable to attend the interview.
Clarithromycin as Adjuvant to Periodontal Debridement

To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.

To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.Forty patients were select and randomly assigned into two groups: Group clarithromycin with 20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days; group placebo with 20 subjects that received FMUD associated with placebo. Probing depth (PD), gain in clinical attachment level (CAL) and bleeding on probing (BOP) were evaluated at baseline, 3 and 6 months post- operatively.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Generalized Aggressive Periodontitis
* presence of ≥20 teeth
* presence of ≥ 6 sites presenting probing depth (PD) ≥5mm with bleeding on probing (BOP) and ≥2 sites with PD ≥7mm (including incisors and first molars, in addition to two other non-contiguous teeth between them)
* good general health
* \<35 years of age
* agree to participate in the study and sign a written consent

Exclusion Criteria:

* pregnant or lactating
* suffering from any other systemic disease (e.g. cardiovascular, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease
* received antimicrobials in the previous 6 months
* taking long-term anti-inflammatory drugs
* received a course of periodontal treatment within the last 12 months
* smoked
Evaluating Factors Affecting Survival in Colon and Rectum Cancer

Colorectal cancers are frequent among cancers of the gastrointestinal system. Whether there are any differences between survival in rectum and colon cancer patients is controversial. This study aimed to compare survival in the surgically treated rectum and colon cancers and determine the factors affecting survival.

Colorectal cancers are frequent in the gastrointestinal system. It is the 4th most common cancer after lung, prostate, and bladder in the male population and it is the 3rd after breast and thyroid cancers in the female population according to World Health Organization. It is considered significant morbidity and mortality cause and is estimated to develop in more than 1.000.000 individuals annually worldwide. Colorectal cancers form 10% of all cancers in the female and male populations. It is the 2nd most common cause of death among cancers in the United States of America.

In studies, it is stated that the risk of developing colorectal cancer in an individual is 5-6%. Also, the risk of death of an individual due to colorectal cancer was determined as 3%. In the last 50 years, the rate of colorectal cancer mortality decreased in the female population while it did not change in the male population. Whether there is a difference in survival time between rectum and colon cancers is controversial.

With the development in neoadjuvant treatment approaches, poor prognosis in past years got better. Recent studies show that the prognosis in rectum cancers is better than in colon. Nevertheless, factors affecting prognosis other than treatment for both colon and rectum cancers are not clarified.

In this study, the investigators aimed to evaluate the surgically treated rectum and colon cancer patients' survival and factors affecting survival time.

Eligibility Criteria:
Inclusion Criteria:

Patients who were operated and diagnosed histopathologically as adenocarcinoma were included.

Exclusion Criteria:

Inoperable and recurrent colorectal cancer patients and patients that were diagnosed with other than adenocarcinoma were excluded from the study.
Preventive Treatment of VETD in Patients With Multiple Myeloma Receiving Chemotherapy With Thalidomide or Lenalinomide.

Patients with multiple myeloma have seen their survival rate strongly improved with the use of new anti angiogenic agents. Among them, the new chemotherapy with thalidomide or lenalinomide are frequently successfully suggested in therapeutic protocol such as MPT however they can strongly increase the risk of venous thrombo embolic disease (DVT and PTE) up to 20%. In these conditions, a prevention of this risk can be proposed by physician with either low molecular weight heparin (LMWH) anticoagulants or antiplatelets agents. Pending the new recommendations on the management of VTED, the purpose of this study is to describe in real life conditions the management by oncologists of the thrombo embolic risk for such patients


Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple myeloma receiving a chemotherapy protocol including thalidomide or lenalidomide

Exclusion Criteria:

* Patients involved in an interventional clinical trial