cyrilzakka/clinical-trials huggingface dataset:
Use of Real-time Fluorescence Imaging in Diabetic Foot Ulcers: the Impact of Colonization

The study evaluates the efficacy of fluorescence-guided de-colonization in patients with non-infected diabetic foot ulcers. The efficacy will also be compared between those who used artificial dermis and split-thickness skin graft for reconstruction surgery.

Diabetic foot ulcers (DFU) are the main cause of hospitalization in diabetic patients. These hard-to-heal ulcers have a high amputation rate, and a 5-year mortality rate of 50% once being amputated. Treatments for DFU include infection management, wound debridement, revascularization, pressure off-loading, etc. Recently, a novel imaging device called MolecuLight i:X was introduced to help visualize clinically undetectable fluorescent bacteria in wounds and has shown promising effects in the identification of infection. However, as microorganisms almost colonize all chronic wounds, the term "bacterial colonization" should be distinguished from clinical infection. While infection delays the healing process, the impact of colonization on wound reconstruction remains unclear; and the assessment is often more difficult on DFU patients with peripheral neuropathy and vascular diseases. In the present study, investigators will conduct a prospective randomized controlled trial to evaluate the clinical outcome of achieving "high-quality de-colonization" with the aid of MolecuLight i:X in the treatment of noninfected DFU patients, and to compare its efficacy between artificial dermis and split-thickness skin graft.

Eligibility Criteria:
Inclusion Criteria:

1. 20 ≤ age \< 80
2. Body mass index (BMI) \< 35 kg/m2
3. Glycated hemoglobin (HbA1c) \< 10%
4. Target ulcer: (1) 10 ≤ size \< 100 cm2 (2)Located on or below malleolus (3)Wagner's grade 2 or 3 initially (4)Margin \> 3 cm between target ulcer and other ulcers
5. Transcutaneous oxygen pressure (TcPO2) ≥ 30 mmHg and 0.8 ≤ ankle-brachial index (ABI) ≤ 1.2
6. Patient willingness and signed informed consent

Exclusion Criteria:

1. Pregnancy
2. Type I diabetes mellitus (Type I DM)
3. Active malignancy
4. Taking glucocorticoids, immunosuppressants, or in an immunocompromised status
5. Lab test upon admission for reconstruction surgery: (1) hemoglobin (Hb) \< 8.0 g/dL, or white blood cell (WBC) \< 3000 cell/μg (2) aspartate aminotransferase (AST) / alanine aminotransferase (ALT) / total bilirubin \> 3x upper normal limits (3) albumin \< 2.5 g/dL
Usability, Immediate, and 30 Day Effect of External Neuromodulation With iTEAR100 Generation 2 in Dry Eye Patients

iTEAR generation 2 will be supplied t eligible subjects at Day 0. At Day 30, symptom questionnaires and ophthalmic exam will be performed.

TEAR generation 2 will be supplied t eligible subjects at Day 0. At Day 30, symptom questionnaires and ophthalmic exam will be performed. At both exam days, a Schirmer test before and after will be performed as well as parameters which indicate immediate effect of treatment and treatment over the 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Dry eye

Exclusion Criteria:

* unable to read consent
* investigator discretion
Strategies of Interruption/Reinitiation of Antiretroviral Therapy in HIV-Infected Patients With Lipodystrophy

Aim: To assess the safety on the progression of HIV infection and the efficacy on the evolution of metabolic parameters and body fat of either viral load- or CD4 cell-driven strategies of intermittent treatment in chronically HIV-1-infected persons.

Design: Pilot, prospective, open, randomized, controlled 3-year study.

Setting and patients: University hospital. Patients with viral load \<200 copies/mL and CD4 cell count \>450/mm3 for at least the last 3 months. Three arms with 50 patients each, that will be randomized either to continue antiretroviral therapy, or to discontinue it as long as either HIV-1 RNA be lower than 30000 copies/mL or CD4 cell count be higher than 300/mm3.

Study end-points: evolution of plasma metabolic parameters, body fat, and bone mineral density; incidence of adverse effects due to antiretroviral therapy and symptoms consistent with acute retroviral syndrome; incidence of virological failure (plasma HIV-1 RNA \>200 copies/mL while on therapy), immunological failure (CD4 cell count \<200/mm3 while on therapy), or clinical failure (development of AIDS-defining illnesses); cost of antiretroviral therapy administered and time free of therapy in the arms assigned to intermittent treatment; and the evolution of T lymphocyte subpopulations and the development of proliferative and cytotoxic responses against HIV.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected patients
* On stable antiretroviral therapy
* Viral load below 200 copies/ml
* CD4 above 450 cells/mcl during last 3 months

Exclusion Criteria:

* Weight variation higher than 10% compared with previous stable weight
* Active (CDC-C) opportunistic events
* Major depression or schizophrenia under psychiatric treatment
* Lack of clinical stability
* Pregnant women or planning pregnancy
A Study to Determine the Safety and Efficacy of LX3305 in Subjects With Active Rheumatoid Arthritis

The primary objective of this study is to determine the safety of LX3305 in a dose escalation compared with placebo over 12 weeks in subjects with active rheumatoid arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects, aged 18 to 75 years
* Active rheumatoid arthritis (RA), class I to III (defined by the American College of Rheumatology), diagnosed at least 3 months prior to Screening
* Minimum of 4 swollen joints (at Screening and Day 1), minimum of 4 tender joints (at Screening and Day 1), and serum C-reactive protein (CRP) level \>1.2x the upper limit of normal and/or elevated erythrocyte sedimentation rate (ESR)
* If receiving methotrexate (7.5 mg to 25 mg/week), subject must have been treated for at least 6 weeks prior to Screening and currently receiving a stable dose of methotrexate (MTX) with a stable route of administration, and have no plans to change MTX dose during the study
* Ability to give written informed consent

Exclusion Criteria:

* Women who are pregnant or nursing
* RA diagnosis prior to 16 years of age (juvenile RA)
* Intra-articular and/or parenteral corticosteroids within 4 weeks of study Day 1
* Receipt of live vaccine within 4 weeks prior to Day 1
* Major surgical procedure within 8 weeks prior to Day 1
* Blood donation within 4 weeks prior to Day 1
* Any systemic inflammatory condition
* History of bleeding diathesis
* History of medically significant opportunistic infection
* History of drug or alcohol abuse within 3 years prior to Day 1
* History of cancer within 5 years prior to Day 1
* Presence of hepatic or biliary disease
* History of tuberculosis
* History of human immunodeficiency virus (HIV)
* Any clinically significant laboratory test results, in the opinion of the investigator
* Use of any investigational agent or participation in an investigative trial within 30 days of Day 1
* Concurrent use of any biologic agent for the treatment of RA or concomitant disease modifying antirheumatoid drugs (other than MTX, hydroxychloroquine, leflunomide, and sulfasalazine - at stables doses for 8 weeks)
ANCHORS Alcohol & Sexual Health Study: UH3 Project

80 young adult men will complete an initial survey and receive 1 of 2 types of alcohol and sexual health education and information to encourage prevention of alcohol-related problems, HIV and other sexually transmitted infections (STIs). Participants will then take pre-exposure prophylaxis (PrEP) for HIV prevention and complete a daily 5-minute, telephone-based interactive voice response (IVR) assessment of alcohol/substance use, sexual behavior and PrEP taking for 30 days. Medication will all be active PrEP. There is no placebo control in this study. Follow-up will occur after 30-days and 6-months later.


Eligibility Criteria:
Inclusion Criteria:

* Ability to read and write English
* Consumption of 5 or more drinks per drinks in a day at least once in the past 30-days
* Sexual intercourse with another man without condom use at least once in the past 30 days
* HIV seronegative at medical screening
* Report currently taking PrEP willingness to take PrEP

Exclusion Criteria:

* History of clinically significant withdrawal from alcohol, defined as any one of the following: a) a lifetime history of seizures, delirium, or hallucinations during alcohol withdrawal; b) a Clinical Institute Withdrawal Assessment scale score \> 8; c) a report of drinking to avoid withdrawal symptoms in the past 12 months; or d) a lifetime history of medical treatment for withdrawal.
* Self report injection drug use
* DSM-5 criteria for moderate or severe current substance use disorder besides alcohol and nicotine.
* Serious psychiatric symptoms
* Use of medications that interfere with PrEP including diuretics, nephrotoxic drugs, non-steroidal anti-inflammatory drugs, antiretroviral drugs or other drugs that may interfere with tenofovir excretion
* Active hepatitis B infection
* The following medical exclusions: serious or life-threatening conditions; inadequate biochemical, hepatic, hematologic, or pancreatic function according to laboratory testing
* Participant reports currently taking injectable PrEP
A Study for Patients With Multiple Sclerosis

To obtain additional safety data in subjects who have previously completed the MBP8298-01 study "A Double Blind Placebo Controlled Multi-Centre to Evaluate the Efficacy and Safety of MBP8298 in Subjects with Secondary Multiple Sclerosis" Dirucotide is generic name for MBP8298.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects participating in this study must have completed treatment and all required evaluations in the previous MBP8298-01 study "A Double Blind Placebo Controlled Multi-Centre Study to Evaluate the Efficacy and Safety of MBP8298 in Subjects with Secondary Progressive Multiple Sclerosis",
2. Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial in accordance with regulatory requirements,
3. In the Investigator's opinion, subjects must be reliable, compliant and agree to cooperate with all trial evaluations.

Exclusion Criteria:

1. Use of any concomitant disease modifying therapy for Multiple Sclerosis e.g. ß-interferon, glatiramer acetate or mitoxantrone, cyclophosphamide, methotrexate, azathioprine, or any other immuno-modulating (e.g. IVIG) or immunosuppressive drugs including recombinant or non-recombinant cytokines.
2. Any medical, psychiatric or other condition that could result in a subject not being able to give fully informed consent, or to comply with the protocol requirements.
3. Any other condition that, in the Investigator's opinion, makes the subject unsuitable for participation in the study.
4. Females who are breast feeding, pregnant or not using a medically approved method of contraception regularly.
INtraoperative photoDYnamic Therapy of GliOblastoma

The study pilot evaluate the feasibility of a "5-ALA- PpIX (protoporhyrin IX) mediated per-PDT protocol" in patients with glioblastoma accessible for complete surgical removal of contrast. This treatment will be carried out in addition to the current reference treatment of glioblastoma: maximum resection surgery followed by radiochemotherapy according to the protocol Stupp


Eligibility Criteria:
Inclusion Criteria:

1. Patient male or female ≥18 years
2. General status (WHO) of Performance status 0, 1 or 2
3. Probable glioblastoma according to clinical and radiological criteria,
4. whose surgical indication was given in Multidisciplinary consultation meeting (RCP) of neurooncology,
5. Decision to treat the patient as part of the Clinical trial also taken in neuro-oncology RCP ("Multidisciplinary consultation meeting")
6. Patient operable on the basis of absence of cardiopulmonary disease history; a complete medical check-up sufficient to insure a post-operative state with normal daily life
7. Clinical neuro-oncological monitoring and long-term MRI scheduled at the hospital CHRU of Lille, center of reference of the region
8. Patient able to understand and sign voluntarily Informed consent
9. Patient able to adhere to the visit's calendar of the study and other imperatives of the protocol
10. Women of child-bearing potential should benefit of an effective contraception
11. For patients receiving hepatotoxic therapy in the long term, this treatment must be suspended during the 24h after taking 5-ALA
12. Patient assigned to an heath insurance

Exclusion Criteria:

1. Contraindications to 5-ALA (Gliolan®) and to per-operative PhotoDynamic Therapy "perPDT":
2. Contraindications to 5-ALA

   * Porphyria
   * Taking photosensitizer treatment
   * Severe renal or hepatic impairment
   * Bilirubin\> 1.5 x maximum level, Alkaline Phosphatases and transaminases (ASAT)\> 2.5 x Maximum. rates
   * Creatinine clearance \<30 mL / min;
   * Non-compliance with the rules of prevention of the transient risk of cutaneous photosensitization
3. Contraindications to surgery
4. Contraindications to magnetic resonance imaging (MRI)
5. Treatment with an experimental drug within 30 Days prior to the start of the study
6. Clinical follow-up impossible to perform for psychological, familial, social or geographical reasons,
7. Legal incapacity (persons deprived of their liberty or Guardianship or guardianship),
8. Pregnant or nursing women
9. Refusal to participate or sign the consent of the study
10. Soy allergy
An Observational Study of the Progression of Intermediate Age-Related Macular Degeneration

This is a multicenter prospective study in participants with intermediate age-related macular degeneration (iAMD). One primary objective of this study is to assess iAMD disease progression, by the timeline and rates of conversion for high-risk iAMD at baseline to more advanced atrophic AMD stages. The other primary objective of this observational study is to assess the feasibility of measuring the rate of photoreceptor loss as a potential clinical endpoint. The study will consist of an observation period of approximately 3 years (\~144 weeks) for participants.


Eligibility Criteria:
Inclusion Criteria:

* For women of childbearing potential, agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, during the study for at least 28 days after the last fluorescein injection for the fluorescein angiography (FA) administration
* Study eye: High-risk intermediate AMD

Exclusion Criteria:

* Macular disease in either eye with subretinal deposits not typical of AMD
* Pigmentary abnormalities of the retina in either eye not typical of AMD
* Atrophy in either eye due to causes other than AMD
* Study eye: Any concurrent or history of ocular or intraocular condition
* Study eye: Intraocular surgery, including cataract surgery, within 3 months prior to Day 1
* Study eye: Retinal tears or peripheral retinal breaks within 3 months prior to Day 1
* Study eye: Concurrent or history of retinal laser photocoagulation or anti-vascular endothelial growth factor (anti-VEGF) treatment for exudative MNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy
* Study eye: Presence of choroidal nevus with overlying drusen in the circle with a radius 3600 micrometer centered on the fovea
* Study eye: Previous participation in interventional clinical trials for GA or early stages of AMD, except for vitamins and minerals, regardless of the route of administration within the last 6 months, except for sham-arm participants
* Study eye: History of glaucoma surgery, corneal transplant, retinal pigment epithelium tear, retinal tear that involves the macula, retinal detachment
* Either eye: Uncontrolled progressive glaucoma
* Either eye: Moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy
* Either eye: History of recurrent infectious or inflammatory ocular disease
* Any concurrent or history of taking medications that can induce retinal toxicity
Elimination of CD4+CD25+ Regulatory T Cells in Patients With Hepatocellular Carcinoma

It has been shown that patients with advanced HCC have an increased frequency of CD4+CD25+ regulatory T cells. These cells might suppress tumor-specific immune responses. Cyclophosphamide has been shown to reduce the frequency of CD4+CD25+ regulatory T cells. The aim of this study is to test if the treatment with cyclophosphamide leads to a decrease in the frequency of CD4+CD25+ regulatory T cells and to increase tumor specific immune responses in patients with advanced HCC.


Eligibility Criteria:
Inclusion Criteria:

* adequate WBC
* adequate liver and kidney function
* no immunodeficiency
* ECOG \< 2

Exclusion Criteria:

* advanced liver cirrhosis
* severe cardiopulmonary diseases
HEALEY ALS Platform Trial - Regimen A Zilucoplan

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.

Regimen A will evaluate the safety and efficacy of a single study drug, zilucoplan, in participants with ALS.

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. This trial is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. The HEALEY ALS Platform Trial Master Protocol is registered as NCT04297683.

Once a participant enrolls into the Master Protocol and meets all eligibility criteria, the participant will be eligible to be randomized into any currently enrolling regimen. All participants will have an equal chance of being randomized to any currently enrolling regimen.

If a participant is randomized to Regimen A - Zilucoplan, the participant will complete a screening visit to assess additional Regimen A eligibility criteria. Once Regimen A eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active zilucoplan or matching placebo.

Regimen A will enroll by invitation, as participants may not choose to enroll in Regimen A. Participants must first enroll into the Master Protocol and be eligible to participate in the Master Protocol before being able to be randomly assigned to Regimen A.

For a list of enrolling sites, please see the HEALEY ALS Platform Trial Master Protocol under NCT04297683.

Eligibility Criteria:
Inclusion Criteria:

* The following inclusion criterion is in addition to the inclusion criteria specified in the Master Protocol (NCT NCT04297683).

  1. Vaccination with a quadrivalent meningococcal vaccine and meningococcal serotype B vaccine at least 14 days prior to the first dose of study drug at the Baseline (Day 0) visit. Meningococcal vaccines (including boosters) should be administered in accordance with the study's vaccination worksheet.

Exclusion Criteria:

* The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683).

  1. History of meningococcal disease.
  2. Prior treatment with a complement inhibitor.
Powerful Tools for Caregivers of Dementia Patients

The purpose of this study is to examine if a psycho-educational intervention for caregivers of patients with dementia will decrease caregiver burden, increase caregiver physical activity, and decrease the reporting of behavioral and psychological symptoms of the person with dementia.


Eligibility Criteria:
Inclusion Criteria:

* Caregiver lives with or provides care for the care recipient for an average of at least 4 hours per day.
* Care for an individual with a physician diagnosis of dementia (mild to moderate stage of dementia).
* Care for a care recipient who experiences behavioral symptoms that bother or upset the caregiver moderately, very much, or extremely. The occurrence of problematic behaviors and caregivers' reactions will be assessed with 6-items adapted from the Revised Memory and Behavior Problems Checklist (Teri et al 1992).

Exclusion Criteria:

* Care for a care recipient who is bed-bound or has advanced dementia: Functional Assessment Staging (FAST)(Sclan \& Reisberg 1992) stage 7.
* Caregiver's cognitive, hearing, visual, or other physical impairments lead to difficulty with informed consent process, assessment, or participation in the intervention.
* Caregiver who is involved in another trial that addresses caregiver burden or behavioral expressions.
A Phase 2 Study of BGJ398 in Patients With Recurrent GBM

This is an open-label non-randomized, multicenter, phase II study of BGJ398 administered to adult patients with histologically confirmed GBM and/or other glioma subtypes with FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3.

Patients were enrolled in two groups. Group 1 enrolled patients who are not candidates for surgery. Group 2 was planned to enroll patients who are surgical candidates. Patients from both groups were evaluated for tumor response and progression by MRI every 8 weeks until disease progression or discontinuation from study using RANO criteria.

Eligibility Criteria:
Inclusion criteria:

1. Patients with histologically confirmed GBM and/or other glioma subtypes at the time of diagnosis or prior relapse.
2. Written documentation of local or central laboratory determination of amplification or translocation to FGFR1-TACC1, FGFR3-TACC-3 fusion and/or activating mutation in FGFR1, FGFR2,or FGFR3
3. RANO defined tumor progression by MRI in comparison to a prior scan
4. Patients must have received prior external beam radiotherapy and temozolomide.

Exclusion criteria:

1. History of another primary malignancy
2. Prior or current treatment with a FGFR inhibitor
3. Neurological symptoms related to underlying disease requiring increasing doses of corticosteroids
4. Patients must not be taking Enzyme Inducing Anti-Epileptic Drug (EIAED). If previously on an EIAED, the patient must be off of it for at least two weeks prior to study treatment.
Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism (VTE) in Medical Patients With Renal Insufficiency

Fondaparinux is a parenteral anticoagulant drug and is approved for the prevention of venous thromboembolism in high risk medical patients. A relevant proportion of medical patients have moderate to severe renal insufficiency, which is an independent risk factor for bleeding. This risk may be further increased when low molecular weight heparin or fondaparinux are administered in patients with severe renal insufficiency, defined by a creatinine clearance of lower than 30 mL/min. No clear indications are available to reduce such risk in patients who require thromboprophylaxis. A lower dose of fondaparinux, 1.5 mg daily, has been recently approved for the prevention of venous thromboembolism in the specific population of patients with a creatinine clearance between 20 and 50 mL/min (European Marketing Authorization). However, there are to our knowledge no clinical studies that have assessed the safety and efficacy of this reduced dosage in medical patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 60 years
* Acute medical disease requiring thromboprophylaxis according to international guidelines
* Anticipated immobilization of at least 4 days
* Renal insufficiency defined by creatinine clearance between 20 and 50 mL/min according the MDRD formula
* Written informed consent

Exclusion Criteria:

* Active bleeding or bleeding in the previous 3 months
* Known bleeding diathesis
* Platelet count \< 100.000
* Ongoing treatment with unfractionated heparin, low molecular weight heparin, fondaparinux, or vitamin K antagonists
* Use of prophylactic doses of heparin, low molecular weight heparin, or fondaparinux in the previous 72 hours
* Life expectancy \< 1 month