cyrilzakka/clinical-trials huggingface dataset:
Effectiveness and Safety of Synvisc® Versus Usual Treatments in Patients With Knee Osteoarthritis

Comparison of treatment cost of knee osteoarthritis (OA) in patients treated with Synvisc® versus usual treatments as well as evaluation of safety and effectiveness of these treatments.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatient aged at least 18 years
* Patient suffering from predominant femoro-tibial knee osteoarthrosis with or without effusion. The diagnosis must be based on American College of Rheumatology (ACR) criteria. Radiological grade will be assess according to Kellgren-Lawrence scale
* Assessment of pain on active movement (i.e. walking) (by the patient) must be at least 40 mm on a 100 mm VAS
* Patient who received at least two courses of at least ten days within the last three months with non-steroidal antiinflammatory drugs (NSAID) and/or who are treated continuously for the last two month with slow-acting anti-osteoarthritis drugs
* Patient's informed written consent obtained in accordance with French legislation

Exclusion Criteria:

* Patient suffering from acute congestive osteoarthritis flare of the target knee (at the time of inclusion) which means that concomitantly to knee effusion at least 2 of the following criteria are present:

  * nocturnal disturbances due to knee pain
  * morning stiffness over 45 minutes
  * increase of knee pain more than 50% within the last week
  * articular reddening
  * articular heat
* Intra-articular administration of hyaluronic acid in the target knee within the previous year
* Intra-articular administration of hyaluronic acid in the target knee within the three previous months
* Any other intra-articular injection in the target knee within the last 6 months
* Any contraindication to intra-articular injections
* Present or past history of infected target knee joint
* Previous prosthesis knee surgery, tibial osteotomy, synovectomy or synoviorthese of the target knee
* Arthroscopy, articular lavage, debridement, menisectomy of the target knee within the previous year
* Planned knee surgery within the nine following month
* Any other musculoskeletal disorders that can interfere with osteoarthritis diagnosis or the evaluation of its severity
* Known hypersensitivity to avian products
* Presence of lymphatic or venous stasis
* Pregnancy or breastfeeding
* Clinical evidence of or known severe cardiac, hepatic, renal, metabolic, haematological disease, mental disturbance
* Participation in another clinical trial during this study or during the previous month
* Previous participation in this trial
* Patient who requires help concerning shopping or house keeping
* Patient unable to comply with the protocol (e.g. patient unable to attend each trial visit or to fill the diary booklet or the quality of life questionnaire)
A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients

REHAB-HF: A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients, is a multicenter, randomized, attention-controlled, single-blind trial designed to examine the hypothesis that, in addition to standard care, a novel, tailored, progressive, multi-domain rehabilitation intervention administered to older patients with acute decompensated heart failure (ADHF) beginning early during hospitalization and continuing for 12 weeks will improve physical function and key clinical outcomes, including the rate of rehospitalization.

There will be three lead centers, Wake Forest Baptist Health along with Thomas Jefferson University and Hospital-Co-Investigator Dr. David Whellan, and Duke University Medical Center-Co-Investigator Dr. Christopher O'Connor. Each center may recruit up to 3 geographically close, tightly affiliated 'satellite' sites under their management and budgetary control. Together, these sites will recruit a total of 352 consenting patients ≥ 60 years old hospitalized with ADHF. Following informed consent and baseline testing, the participants will be randomized in a 1:1 fashion to receive a 12-week novel, progressive, multi-domain rehabilitation and exercise training intervention or attention control. The multi-domain rehabilitation intervention will include endurance, mobility, strength, and balance training and will be tailored based on participant performance in each of these domains. It will begin upon randomization during the hospitalization and will continue 3 times per week in an outpatient setting. Participants randomized to the attention control arm will receive all services ordered by their primary physician and will be contacted bi-weekly by study staff. All participants will undergo measures of physical function and quality of life at baseline, 1 month, and 3 months. Clinical events will be monitored for 6 months following the index hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years old
* In the hospital setting \>24 hours for the management of ADHF, or diagnosed with ADHF after being hospitalized for another reason. ADHF will be confirmed by the study physician, and will be defined according to the Food and Drug Administration definition of hospitalized heart failure as a combination of symptoms, signs, and HF-specific medical treatments.

Exclusion Criteria:

* Acute myocardial infarction
* Planned discharge other than to home or a facility where the participant will live independently
* Already actively participating in formal, facility-based cardiac rehabilitation
Sulforaphane to Reduce Symptoms of Schizophrenia

The purpose of this study is to determine if taking a sulforaphane nutraceutical versus a placebo will reduce symptoms of schizophrenia when used in addition to standard antipsychotic medications.


Eligibility Criteria:
Inclusion Criteria:

* Capacity for written informed consent
* Age 18-65 years, inclusive
* Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder as determined by the Structured Clinical Interview for DSM-5 Disorders (SCID-5)
* Currently an outpatient at time of screening
* Residual psychotic symptoms of at least moderate severity as evidenced by a Positive and Negative Syndrome Scale (PANSS) total score of 60 or higher AND one or more of the following: one or more PANSS positive symptom scores of 4 or higher; OR containing at least three positive or negative items with scores of 3 or higher at the screening visit
* Receiving antipsychotic medication for at least 8 weeks prior to enrolling in the study with no antipsychotic medication changes within the previous 21 days from visit 2 (week 0)
* Conformance to PORT Treatment Recommendation about Maintenance Antipsychotic Medication Dose
* Proficient in the English language
* Participated previously in one of our screening studies

Exclusion Criteria:

* Any clinically significant or unstable medical disorder as determined by the principal investigator and/or the study physician (e.g., HIV infection or other immunodeficiency condition (such as receiving chemotherapy), uncontrolled diabetes, congestive heart failure)
* DSM-5 diagnosis of intellectual disability or comparable diagnoses determined by previous versions of the DSM
* DSM-5 diagnosis of a moderate or severe substance use disorder, except for caffeine or tobacco, within the last three months prior to the screening visit. If the patient has a positive drug toxicity screen at the time of visit 1 (screening), further evaluation by the investigator will be done of the substance use to determine eligibility.
* Any current use of a broccoli supplement (e.g., Avmacol® or other health food broccoli supplement)
* Participated in any investigational drug trial in the past 30 days prior to the screening visit
* Pregnant, planning to become pregnant, or breastfeeding during the study period
Acute Treatment of Bipolar II Depression

This study will compare the medications lithium and lamotrigine (Lamictal®) in treating depression in individuals with bipolar II disorder.

Bipolar II disorder (BDII) is a serious condition characterized by depressive and hypomanic episodes. The disability and suicide risk associated with BDII is equal to bipolar I disorder. However, there are no clinical trials for BDII, nor is the treatment of BDII addressed in current treatment guidelines. Data suggest that Li and LTG may be effective treatment options for BDII. This study will determine the safety, effectiveness, and tolerability of the two drugs in people with BDII.

Participants in this study will be randomly assigned to receive either Li or LTG for 16 weeks. Participants will be assessed every 2 weeks. One week after study completion, participants will have a follow-up visit. Measures of depression, mania, quality of life, functioning, and participant satisfaction will be taken.

Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of bipolar II disorder

Exclusion Criteria:

* Use of lithium or lamotrigine
* Intolerance to lithium or lamotrigine
* Substance abuse or dependence within the last month
* Suicidal thoughts
* Unstable medical conditions
* Pregnancy or breast-feeding
* Stable on current medications
* Use of fluoxetine (Prozac) within 2 weeks of study
* Require an antipsychotic medication
* Do not speak or read English
Virtual Reality for Preoperative Anxiety in Interventional Cardiology

Improving the management of perioperative anxiety is important. Anxiety can have an impact on the intervention and can increase postoperative complications as well as emotional and behavioral incidents that then have an impact on adherence to care. These findings are also true in interventional cardiology. That is why, for several months, the Grenoble University hospital paramedical team, in collaboration with the medical profession, improved by using several techniques (educational sheet, therapeutic communication). Following a survey of the patients of Grenoble university hospital, a gray area persists in their care. The room where the patient attends his examination. The investigators would then use the new technology that makes virtual reality in the transfer room to evaluate its benefit in a random study on preoperative anxiety in interventional cardiology.


Eligibility Criteria:
Inclusion Criteria:

* Major male or female patient
* Coronarography procedure programmed for exploration of coronary artery disease following a positive ischemia test, realized in ambulatory
* Patient who has given written consent to participate in the study

Exclusion Criteria:

* Arrhythmia patient and / or patient with a pacemaker
* Hemodynamic instability
* Patient who has already had coronarography
* Prior revascularization by coronary bypass
* End-stage renal disease (Creatinine clearance \<30 ml / min),
* Allergy to iodine contrast agent
* Blind or visually impaired patient (high degree)
* Deaf or hard of hearing patient
* Patient with claustrophobia or unable to wear a mask over the eyes
* Patient whose physical or psychological state could compromise obtaining informed consent and compliance with protocol requirements
* Patient under administrative or judicial supervision
* Foreign patient who does not understand French
* Major patient protected by law (article L1121-8 and L1121-5)
* Pregnant or lactating patient
* Patient not affiliated with social security
Study of Intravitreal REGN2176-3 in Participants With Neovascular ("Wet") Age-Related Macular Degeneration (AMD)

The primary objective of the study was to explore the effect of REGN2176-3 on the Early Treatment Diabetic Retinopathy Scale (ETDRS) best-corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (AMD), compared to intravitreal aflibercept injection (IAI) monotherapy.

The secondary objectives of the study were the following:

* To explore the effect of 2 dose levels of IVT REGN2176-3 on anatomical changes of CNV in participants with nAMD compared to IAI monotherapy (at week 12)
* To evaluate if short-term treatment with REGN2176-3 followed by IAI monotherapy offered the same or additional benefit compared to continuous treatment with REGN2176-3. Also to determine if there was benefit in initiating IAI treatment prior to REGN2176-3 compared to continuous treatment with IAI.
* To assess the safety and tolerability of IVT REGN2176-3 in participants with nAMD


Eligibility Criteria:
Key Inclusion Criteria:

1. Men or women ≥50 years of age
2. Active subfoveal CNV secondary to AMD as evidenced by FA in the study eye, as determined by the reading center, including juxtafoveal lesions that affect the fovea
3. BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye at the screening visit
4. Provide signed informed consent

Key Exclusion Criteria:

1. Any prior treatment with anti-VEGF treatment in the study eye
2. Any prior treatment (ie, systemic or ocular treatment) with PDGF or PDGFR inhibitors
3. Dense fibrotic scar or atrophy in the study eye involving the center of the fovea
4. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye
5. Prior vitrectomy in the study eye
6. Any history of macular hole of stage 2 and above in the study eye
7. Any intraocular or periocular surgery within 3 months of day 1 in the study eye, except lid surgery
8. History of corneal transplant in the study eye
9. Evidence of diabetic retinopathy or diabetic macular edema in either eye
10. Positive serum human chorionic gonadotropin/urine pregnancy test at the screening or baseline visit
Intensive Care Unit Acquired Infections in Patients Colonized With Extended Spectrum Enterobacteriaceae

Worldwide emergence of extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) had become a major problem in ICU, with at least 10% of incidence at the admission in Europe. A systematic rectal swab is used in 70% of French ICU to detect intestinal ESBL-E carriage The relationship between intestinal carriage and ICU-acquired infection is not perfectly known. The investigators conducted a five years study monocentric retrospective observational cohort in patients with presence of extended-spectrum β-lactamase-producing Enterobacteriaceae in systematic rectal swabs to investigate which type of infections and which bacteria are involved.

The investigators also collect data about antibiotherapy used to treat these infections.

Intestinal carriage of extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) had become a major problem in general population, morover in intensive care units. Systematic rectal swab for screening is done in 70% of French ICU in routine. Some studies had show a good negative predictive value of this test for ICU-acquired infection (for example ventilator-associated pneumoniae), but a poor predictive positive value. The precise relationship between intestinal carriage and ICU-acquired infection is not perfectly known.

Probabilist antibiotherapy with carbapenem for ESBL-E suspected infection are currently recommanded by national and european Guidelines, particulary in case of shock or immunodepression.

A ESBL-E systematic screening-guided strategy for probabilist antibiotherapy could be interesting, and could lead to a carbapenem or a carbapenem-sparing focused antibiotherapy.

The investigators conducted a monocentric retrospective observational cohort study in patients with presence of extended-spectrum β-lactamase-producing Enterobacteriaceae in systematic rectal swabs to investigate the number of ESBL-E related infections, the site of these infections and which species of bacteriae are involved. They also investigate which was the antibiotherapy administered, and investigate what factors lead clinicians to treat the infection with carbapenem antibiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* admitted in Brest ICU (medical or surgical)
* positive rectal swab for ESBL-Enterobacteriae screening at the admission or during the ICU stay
* written consent

Exclusion Criteria:

* refusing to participate
Single-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.

Single-dose nicotine pharmacokinetics with three oral nicotine replacement products.

The study is a single-dose, randomized, crossover study with 24 subjects (all subjects will receive all treatments). The investigational products will be 6 mg, 4 mg and 2 mg Nicotine medicated gum given as single doses at separate treatment visits. Periods without NRT, lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before, and at 2.5, 5, 7.5, 10, 15, 20, 30, 45, and 60 minutes as well as after 1.5, 2, 4, 6, and 8 hours after start of product administration. Subjects will also be monitored to capture any adverse events that may occur. The trial is blind in the sense that treatment labels will not be revealed to subjects and trial personnel. Also the bioanalysts, pharmacokineticists and monitor will be unaware of treatment labels.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects, smoking at least 15 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2 and a total body weight of at least 55.0 kg.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.
High Dose Rifapentine Pharmacokinetics, Tolerability and Safety Dosage Rifapentine for Treatment of Tuberculosis

The primary objective of this study is to characterize rifapentine drug levels in patients with TB in relationship to its effectiveness in treating TB and any adverse effects experienced by participants.

This is a one-period, non-blinded, multi-center pharmacokinetic substudy of rifapentine and rifampin in patients with tuberculosis enrolled in Tuberculosis Trials Consortium (TBTC) Study 29. This PK substudy will use a convenience sample, i.e. be restricted to TBTC sites having logistical capacity for intensive pharmacokinetic sampling. These sites will have non-random selection of patients. In addition to the intensive sampling of 60 patients in this PK study, all patients receiving rifapentine in Study 29 will be eligible for sparse PK sampling as part of the parent treatment protocol.

Eligibility Criteria:
Inclusion Criteria:

* Any patient enrolled in TBTC Study 29.
* Provision of informed consent for the study.
* Willingness to be sampled in an out-patient clinic or be admitted to a General Clinical Research Center (GCRC) or hospital on one occasion

Exclusion Criteria:

• Severe anemia as defined by a hematocrit less than 25% (most recent value, measured within 30 days of the PK study).
Antidepressant Efficacy of Psychotherapy and Citalopram in Patients With Breast Cancer and Major Depression

To provide evidence on the antidepressant efficacy of two therapeutic treatments: pharmacological treatment (citalopram) and psychotherapy treatment, in women diagnosed with breast cancer and major depression.


Eligibility Criteria:
Inclusion Criteria:

* Female patients first time diagnosed with breast cancer (stage I, II, III, or IV) between ages 18 and 75 (both inclusive).
* Patients with a "moderate-severe" level of emotional distress who meet the diagnostic criteria for major depression for at least two weeks or adjustment disorder with depressive mood for at least two months, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria (DSM-V), during the twelve months following the diagnose of breast cancer.
* Informed Consent Form Signature

Exclusion Criteria:

* Women who are pregnant or breastfeeding.
* Suicide risk.
* Metastatic brain disease.
* Personal History of oncological disease.
* Personal History of serious somatic disease (cardiac, hepatic, respiratory, endocrinological, neurological and haematological).
* Personal History of organic brain disorder, substance abuse/dependence.
* Personal History of psychotic disorder, bipolar disorder and/or mental retardation.
* Contraindications of citalopram treatment.
* Taking antidepressants after the breast cancer diagnosis.
* Psychotherapy treatment after breast cancer diagnosis .
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)

The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.


Eligibility Criteria:
Inclusion Criteria:

1. Have type 2 diabetes mellitus for at least 1 year.
2. Are at least 18 years old.
3. Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following OAMs for the 6 weeks prior to Visit 1, at or above the doses defined in the following: Metformin--1500 milligrams per day (mg/day); Sulfonylureas--1/2 the maximum daily dose, according to the local package insert; Dipeptidyl peptidase-intravenous (DPP-IV) inhibitors-- 1/2 the maximum daily dose, according to the local package insert; Thiazolidinediones (TZDs)--30 mg/day pioglitazone or 4 mg/day rosiglitazone.
4. Have a hemoglobin A1c (HbA1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before Visit 2.
5. Body mass index (BMI) greater than or equal to 25 and less than or equal to 45 kilograms per square meter (kg/m2).

Exclusion Criteria

1. Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
2. Have taken any glucose-lowering medications not included in Inclusion Criterion \[3\] (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before Visit 1.
3. Have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
4. Have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dL) (177 micromoles per liter \[micromol/L\]).
5. Have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase \[ALT\], or aspartate transaminase \[AST\] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.
Effects of Jeju Red Horsehead Fish-based, High Protein Diet on Satiety and Incretin Hormones in Diabetes Patients

The aim of our study is to investigate the effects of high-protein diet on satiety and incretin hormones in patients with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus
* Subjects signed a written informed consent form

Exclusion Criteria:

* Liver cirrhosis
* Chronic renal disease (serum creatinine \> 2mg/dL)
* Severe congestive heart failure
* Significant infectious or inflammatory diseases
* intractable malignant neoplasm
* Pregnancy