cyrilzakka/clinical-trials huggingface dataset:
Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology

Study team will plan a prospective, randomized control trial using our institution's spine clinical outcomes registry. Eligible patients undergoing ACDF (see inclusion criteria listed below) will be randomized to an Intervention or Control Group, which will differ according to the interbody cage used during the procedure. In the Intervention Group (100 patients), Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology will be implanted at each treated level. In the Control Group (100 patients), patients will receive an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology. Interbody cages used in the Control Group (along with the decision to apply anterior plate fixation) will be determined according to surgeon preference. There will be no blinding to the type of implant used. Standard demographic and procedural variables will be collected for all patients (including history of diabetes, tobacco, use, prior use of oral corticosteroids, number of levels fused, and presence of bicortical screw placement). Clinical and radiographic outcomes in the Intervention and Control Groups will be directly compared.

Aim 1: Examine the effect of nanoLOCK technology on rates of postoperative dysphagia after ACDF.

Aim 2: Evaluate the effect of nanoLOCK technology on radiographic fusion.

Aim 3: Evaluate how nanoLOCK technology influences the development of radiographic adjacent segment disease.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years of age or older
* Subjects undergoing ACDF surgery for degenerative pathology (one, two or three levels)
* Subjects with no prior history of cervical spine surgery
* Subjects with complete/usable data

Exclusion Criteria:

* Subjects under the age of 18
* Subjects not undergoing ACDF surgery
* Subjects with prior cervical spine surgery
* Subjects with cervical neoplastic or infectious disease pathology
* Subjects with cervical trauma pathology
* ACDF performed at C2-3
* Subjects with incomplete/unusable data
Evaluation of Efficacy and Long-term Safety for Lucidis Instant Focus© - PMCF Study Protocol

The objectives of the study is to evaluate efficacy and long-term safety of the Lucidis lens. Through this study, the objective is to obtain an up-to-date clinical evaluation of the medical device thus supplementing data from experimental trials. Clinical and functional changes in the implanted eyes among a patient population in which the opaque crystalline lens resulting from cataract was removed and replaced by a Lucidis IOL will be described.

Refractory function in patients with a cataract is mainly restored by implanting intra-ocular lenses (IOL) destined to replace the crystalline lens. While new surgical techniques for removing the crystalline lens have been developed, these lenses have been considerably perfected to resemble the natural crystalline lens as closely as possible.

The objectives of the study is to evaluate efficacy and long-term safety of the Lucidis lens. Through this study, the objective is to obtain an up-to-date clinical evaluation of the medical device thus supplementing data from experimental trials. Clinical and functional changes in the implanted eyes among a patient population in which the opaque crystalline lens resulting from cataract was removed and replaced by a Lucidis IOL will be described.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (≥18 years)
* having agreed to take part in the study and complete post-operative follow-up requirements (by having signed the information leaflet-informed consent form);
* with;
* for whom the physician made the decision to implant a Lucidis

Exclusion Criteria:

* patient included in an interventional therapeutic trial at the time of inclusion;
* patient presenting contraindications for the implantation of an intraocular lens;
* patient presenting an ophthalmic disorder liable to interfere with the study endpoints;
* patient presenting with an astigmatism ≥1.0 D;
* patient refusing or unable to comply with the follow-up procedures in the study (patient unable to be reached by telephone, liable to be lost to follow-up, etc.);
* History of previous intraocular surgery in the study eye in the previous 6 months;
* patient is pregnant, breast-feeding or unable to make the decision to participate in a clinical investigation (e.g. mentally ill or handicapped person)
Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects

The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-naive subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate to severe low back pain for ≥6 months
* Treating CLBP with a stable daily maintenance dose of non-opioid analgesic medication up to 10 mg morphine sulfate equivalents (MSE) per day for ≥4 weeks. (Additional as needed \[PRN\] non-opioid analgesic medications permitted on top of the stable daily maintenance dose of non-opioid analgesic)
* Stable health, as determined by Principal Investigator
* Are female who are practicing abstinence or using a medically acceptable form of contraception or have been post-menopausal, biologically sterile, or surgically sterile for more than 1 year
* Willing and able to comply with all protocol required visits and assessments

Exclusion Criteria:

* Current cancer related pain or received chemotherapy with 6 months of screening
* Receiving opioid analgesic medication \>10 mg MSE per day within 28 days of screening
* Subjects with a history of other chronic painful conditions
* Reflex sympathetic dystrophy or causalgia, acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
* Allergy or contraindications to any opioid or acetaminophen
* Surgical procedure for relief of pain with 6 months
* Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
* QT interval corrected using Fridericia's formula (QTcF) of ≥450 milliseconds on the 12-lead electrocardiogram (ECG)
* History of long QT syndrome or a family member with this condition
* Moderate to severe hepatic impairment
* Moderate to severe renal impairment
* Current or past history of alcohol abuse
* Positive urine toxicology screen for drug of abuse
* History or abnormalities on physical exam, vital signs, electrocardiogram, or laboratory values
(CHANT)Real World Study of Duvelisib in the Treatment of Non-Hodgkin's Lymphoma (NHL)

This is a multicenter, non-interventional and prospective real-world study to evaluate the efficacy and safety of Duvelisib capsules in patients with non-Hodgkin's lymphoma.

This is a multicenter, non-interventional and prospective real-world study to evaluate the efficacy and safety of Duvelisib administered to subjects who have been diagnosed with non-Hodgkin's lymphoma that is relapsed or refractory, including but not limited to the following subtypes : a) Follicular lymphoma(FL); b) Chronic lymphocytic leukemia/small lymphocytic lymphoma or Richter syndrome(CLL/SLL or RS); c) Marginal zone lymphoma(MZL); d) Peripheral T-cell lymphoma(PTCL); e) Diffuse large B-cell lymphoma(DLBCL).

Eligibility Criteria:
Inclusion Criteria:

* To participate in the study voluntarily and sign the informed consent (ICF), with good compliance and cooperative visits;
* Patients must be ≥ 18 years of age (Based on the date of signing the informed Consent (ICF));
* Pathologically or Histologically confirmed NHL including but not limited to the following subtypes:

  1. Follicular lymphoma (FL);
  2. Chronic lymphocytic leukemia/small lymphocytic lymphoma or Richter syndrome (CLL/SLL or RS);
  3. Marginal zone lymphoma (MZL);
  4. Peripheral T-cell lymphoma (PTCL);
  5. Diffuse large B-cell lymphoma (DLBCL).
* Patients who have received at least one systemic chemotherapy and have relapsed at the end of the treatment or progressed during treatment;
* Must have adequate organ function defined by the following laboratory parameters:

  1. Bone marrow function: Absolute neutrophil count (ANC) ≥ 0.5 × 10\^9/L, Platelet count (PLT) ≥ 25 × 10\^9/L, blood transfusion can be used before medication;
  2. Liver and kidney function: Aspartate transaminase (AST) and alanine aminotransferase (ALT)≤5.0 × ULN;
  3. Estimated creatinine clearance value ≥30 milliliters/minute (as determined by the Cockcroft-Gault method).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
* Patients with infections should be treated first and then considered for enrollment when the infection is under control.

Exclusion Criteria:

* Female subjects who are pregnant or breastfeeding;
* Estimated lifetime is less than 3 months;
* In the investigator's judgment, patients who require but are unable to receive prophylactic treatment for Pneumocystis or herpes simplex virus (HSV) prior to trial drug treatment;
* History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function;
* Prior history of drug-induced colitis or drug-induced interstitial pneumonia;
* Known hypersensitivity to Duvelisib or its excipients;
* Administration of medications or foods that are strong inhibitors or inducers of CYP3A beginning 2 weeks prior to the first dose of Duvelisib;
* According to the judgement of the researcher, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study.
The Cymbalta Pregnancy Registry

The Cymbalta Pregnancy Registry is a U.S. based Registry designed to monitor women who are exposed to Cymbalta (duloxetine) during pregnancy. This is an observational, exposure-registration and follow-up registry.


Eligibility Criteria:
Inclusion Criteria:

* Sufficient evidence (e.g., date or gestational age) to confirm that Cymbalta exposure occurred during pregnancy
* Sufficient data to establish in which trimester of pregnancy the exposure to Cymbalta first occurred (i.e., first, second or third trimester)
* Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (i.e., whether the outcome of pregnancy was known at the time of first contact with the Registry)
* Date the pregnancy exposure is reported to the Registry
* Source of the report (Health Care Professional or pregnant patient)
* Full contact information for the reporter and Health Care Professional willing and able to provide accurate pregnancy-related information (name, address, phone number, etc.)

Exclusion Criteria:

* Reported cases that do not meet the minimum criteria for Registry enrollment are deemed ineligible.
Exploratory Study of a New Urine Collection Device for Men

The aim of the investigation is to evaluate the subjects experience of a new collection device for men.

An open-labelled, single arm study design was chosen for this investigation with a duration of 1 week + up to 3 days extra.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Male
3. Be at least 18 years of age and have full le-gal capacity
4. Suffering from urinary incontinence equiva-lent to using up to 6 pads or 2 diapers per day
5. Have had current incontinence issues for at least 3 months
6. Able to understand patient information and able to change the product himself
7. Up to 6 of the subjects can be users who are using an intermittent catheter due to re-tention, but who are also dribble inconti-nent in-between catheterizations, and hence need a product to handle the inconti-nence.
8. Able to fit the test product.

Exclusion Criteria:

1. If experiencing incontinence less than once per week
2. Bedridden, using wheelchair or using a walking aids regularly
Association Between Patients' Perceptions of Success in Post-op Pain Management and Overall Experience With Care

Assessing the association between patients' perceptions of success with post-operative pain management and overall experience with care.

A study to assess the association between patients' perceptions of success with post-operative pain management following total hip replacement or hysterectomy surgery and their later perception of pain management while in the hospital and the hospital overall.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be 18 years of age or older
* Subject (or their legally acceptable representative) must have signed an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
* Subject is receiving a unilateral total hip replacement or a hysterectomy (total abdominal hysterectomy, total abdominal hysterectomy/bilateral salpingo-oophorectomy, total vaginal hysterectomy, or total vaginal hysterectomy/salpingo-oophorectomy)
* Subject is expected to remain hospitalized for at least 24 hours post-operatively
* Subject is expected to experience pain requiring IV PCA or non-PCA (non-patient controlled opioids via IV, IM, SC, or PO routes of administration) opioids for at least 24 hours after surgery
* Subject is classified as American Society of Anesthesiology (ASA) category I, II, or III
* Subject is willing to complete the required post-operative survey measures to be completed in the hospital
* Subject is willing to complete a post-discharge survey (including HCAHPS survey instrument) via telephone approximately two-weeks (14 days) post-discharge

Exclusion Criteria:

* Subject is having an operation other than the surgical procedures selected for inclusion (e.g., bilateral or partial hip replacement, or hip revision)
* Subject cannot read, write, and communicate in English
* Subject has a history of tolerance to opioids including those prescribed opioids in the 3 month period leading up to the perioperative period (i.e., a subject is considered to have a potential tolerance to opioids if for 4 consecutive days prior to surgery they have been taking a short acting/short acting combination opioid analgesic greater than 120 mg codein daily, 40 mg hydrocodone daily, 200 mg tramadol daily, or 40 mg oxycodone daily or if they were on any dose of strong opioid analgesic such as morphine, hydromorphone, or fentanyl)
* Subject has a history of allergy to opioids reported pre-operatively or documented in medical history
* Subject is scheduled to receive additional surgical procedures beyond those listed within 72 hours of the initial surgery
Safety and Efficacy Study of Topical Methyaminlevulinate (MAL) in Subjects With Facial Acne

A study of safety and efficacy of topical methyaminlevulinate 80mg/g with and without occlusion followed by red light exposure in subjects with facial acne.

Photocure ASA has developed a cream formulation containing methyl aminolevulinate (MAL), an ester of ALA. There is extensive experience with the safety of MAL-PDT in humans.

This study will assess safety and efficacy of four treatments with methylaminolevulinate (MAL) at 80 mg/g performed with and without occlusion and followed by red light exposure 90 minutes later in subjects with facial acne vulgaris. Subjects will be randomized to one of two groups of 20 subjects: Group 1 will receive 25 J/cm2 of red light (45 mW/cm2) and group 2 will receive 37 J/cm2 of red light (90 mW/cm2). For each subject one side of the face will be randomized to receive MAL for 90 minutes without occlusion and the other side of the face will receive MAL for 90 minutes with occlusion.

Eligibility Criteria:
Inclusion Criteria:

* Subject willing to use an adequate contraceptive method or is surgically sterile, post menopausal, abstinent or with a same-sex partner. Adequate means of contraception include; IUD in use 30 days prior to day 0, barrier methods and spermicide in use atleast 14 days prior to day 0 or oral contraceptive in use for at least 6 months prior to day 0
* Age 18 or older
* Capable of giving informed consent
* Diagnosis of acne vulgaris on the face with at least 10 inflammatory lesions on both sides of the face at screening and day 0
* Global acne severity assessment score ≥ 3 at the screening and day 0 visit.

Exclusion Criteria:

* Allergy to methylaminolevulinate or any component of the vehicle
* Acne fulminans or conglobata on the face
* Clinical significant sensitivity to visible light, porphyria or porphyrin sensitivity
* Use of any topical treatment for acne on the face within the previous 2 weeks before day 0
* Any use of systemic antibiotics within 1 month prior to day 0 or use of isotretinoin within 1 year prior to Day 0
* Exposure to ultraviolet radiation (UVB phototherapy, sun tanning salons) within 4 weeks of Day 0
* Use of any investigational drug within 4 weeks of Day 0
* Alcoholism or drug abuse in the past year
* Any unstable or serious medical condition at the discretion of the investigator
* Current pregnancy or lactation
* Use of hormonal contraceptives solely for control of acne
* Current use of oral contraceptives (unless subject is on a stable dose e.i. at least six months of treatment prior Day 0), testosterone or any other systemic hormonal treatment
* Any serious dermatological disorder, including malignancies that would either put the subject at risk or interfere with efficacy or safety evaluations
* Fitzpatrick phototype V or VI (inadequate penetration of red light in dark skin subjects)
* Subjects with extensive facial hair (e.g. beard) that would either impair red light exposure or interfere with lesion evaluation.
Carboxytherapy for Periorbital Dark Circles

the study evaluates carboxytherapy for the treatment of periorbital dark circles

two different concentrations of carboxytherapy administered to patients are compared regarding efficacy

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals with dark circles

Exclusion Criteria:

* infections, scarring, pregnancy, allergy, on treatment for the condition.
Impact of Triclosan-coated Suture on Surgical Site Infection After Colorectal Surgery

Despite adequate antimicrobial prophylaxis and perioperative correction of risk factors, surgical site infections (SSI) remain the most frequent complication of colorectal resection (range 10-17%). Several strategies may be implemented to prevent SSI. Among these, the use of local antimicrobial agents seems successful.

The primary aim of the present trial was to evaluate the efficacy of a surgical suture, coated with Triclosan a synthetic soluble antimicrobial agent, in reducing the SSI rate after colorectal operations.

This was a non-sponsored, multicenter, prospective, randomized, controlled, single-blind study. Two hundred and seventy-three patients candidate to colorectal resection were enrolled. Exclusion criteria were: age \< 18 or \> 85 years, pregnancy, peritonitis, peritoneal contamination during operation, ongoing infections, ASA score \> 3, denied consent.

135 were randomized to the treatment arm and 136 to the control arm. Treatment consisted of abdominal wound closure by suturing peritoneum, fascia, subcutaneous tissue, and skin with Polyglactin 910 Triclosan-coated suture (treatment arm) or with Polyglactin without Triclosan (control arm). SSI were defined according to the Atlanta CDC. Patients were followed up by office visits for 30 days after discharge.

Eligibility Criteria:
Inclusion Criteria:

* patients candidate to elective colorectal resection

Exclusion Criteria:

* no consent
* peritonitis
* hypersensitivity to triclosan
* ASA \> 3
* ongoing infections
Quality Assurance of Cognitive-behavioral Therapy

The study examines associations between competence in cognitive-behavioral therapy (CBT) and adherence to evidence-based generic CBT in therapists and treatment outcome in patients with depression or an anxiety disorder in psychiatric outpatient care.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of major depression or an anxiety disorder (panic disorder, agoraphobia, social anxiety, generalized anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder)

Exclusion Criteria:

* Psychosis, bipolar disorder, eating disorder, substance use disorder, high risk of suicide, any simultaneous psychological treatment
A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)

The purpose of this study is to treat human immunodeficiency virus (HIV) and Hepatitis C Virus (HCV) co-infected subjects with telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) to achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA) 12 weeks after the last planned dose of study drug.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have chronic, genotype 1a or 1b, hepatitis C with HCV RNA greater than (\>) 1000 international units per milliliter (IU/mL)
* Population A: HCV Pegylated interferon (Peg-IFN)/RBV treatment naive (received no prior HCV therapy)or Peg-IFN/RBV prior treatment with relapse
* Population B: Peg-IFN/RBV prior null or partial responder
* Participants must not have achieved undetectable HCV RNA 24 weeks after the last planned dose of study drug (SVR24) after at least 1 prior course of Peg IFN/RBV therapy of standard duration
* Participant must have positive HIV antibody at Screening
* Participant must have a diagnosis of HIV-1 infection \>6 months before Screening
* Participants should be taking 1 of the following permissible highly active antiretroviral therapy (HAART) regimens for HIV continuously for 12 weeks prior to screening:

  * Atripla® or equivalent components (efavirenz, tenofovir, emtricitabine)
  * Efavirenz plus Epzicom® (abacavir, lamivudine) or equivalent components
  * Boosted atazanavir (atazanavir with ritonavir) plus Truvada® (tenofovir, emtricitabine) or equivalent components
  * Boosted atazanavir plus Epzicom®, or equivalent components
  * Raltegravir plus Truvada®, or equivalent components
  * Raltegravir plus Epzicom®, or equivalent components
* Cluster of differentiation 4 (CD4) counts and human immunodeficiency virus Type 1 (HIV-1) ribonucleic acid (RNA) meeting acceptable criteria at Screening as specified in the protocol
* Laboratory values within acceptable ranges at Screening as specified in the protocol

Exclusion Criteria:

* Subjects anticipating a need to switch HAART regimens within 14 weeks after Day 1 or any switches occurring 12 weeks prior to Day 1
* Use of azidothymidine (AZT), didanosine (ddI) or stavudine (d4T) nucleosides
* Contraindications to any planned HAART component as per the respective drug labeling information
* Contraindications to Peg-IFN or RBV
* Evidence of hepatic decompensation
* Clinical suspicion of acute hepatitis
* Any other cause of liver disease in addition to hepatitis C
* History of organ transplantation (except cornea and skin)
* Autoimmune-mediated disease
* Participated in any investigational drug study within 90 days before Day 1
* Previous treatment with an HCV protease inhibitor