cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Intradermal Injections of Newfill Versus Eutrophill in the Treatment of Facial Lipoatrophy in HIV-infected Patients ANRS 132 SMILE

Treatment of facial lipoatrophy with dermal injections polylactic acid (Newfill TM) is a safe procedure and has been now widely used with a good efficacy. However, this therapy is not effective in all treated patients and the benefit of the injections may decrease with time necessitating re-injections several months after the first sets of injections. In this study we would like to compare the efficacy and safety of Eutrophill(polyacrylamid gel), a resorbable filler compound versus Newfill in a comparative, randomised, multicenter trial. Primary endpoint will be the self-perception by the patient with a visual analogue scale (VAS index). Secondary endpoints are a quality of life questionnaire (MOS-HIV), the a-NBC questionnaire (perception by the patient and by the doctor of the severity of the lipoatrophy), the measure of the dermal thickness and cheek skin fold as assessed by the Skinfold Caliper, the ordering of digital photographs and the evaluation of the dermal thickness by CT scan.

The aim of the study is to compare the efficacy and safety of Eutrophill (polyacrylamid gel), a resorbable filler compound versus Newfill( polylactic acid) in a comparative, randomised, multicenter trial and patient-blinded study, in the treatment of facial lipoatrophy in HIV-infected patients, one year after the first injection (week 48). The efficacy will be assessed by measuring the median self-perception index of the patients with a visual analogue scale (VAS index).The study will compare between treatments, at week 48, week 72 and week 96 versus baseline :the median increase of the VAS index, the rate of treatment failure, the scores of 2 patients-questionnaires (a-NBC and MOS-HIV),the ordering of digital photographs,the median increase of the facial dermal thickness of the cheek and the dermal skin fold as assessed by a Skinfold Caliper.

The study will compare at week 48 and week 96 versus baseline:

the median increase of dermal thickness as assessed by CT scan of the face. Safety will be assessed by the frequency and nature of immediate and delayed side effects.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* confirmed laboratory diagnosis of HIV infection
* facial lipoatrophy
* stable antiretroviral treatment or no treatment for at least 3 months
* written informed consent

Exclusion Criteria:

* history of surgical or cosmetic intervention for facial lipoatrophy
* no history of antiretroviral therapy
* current opportunistic infection
* currently stavudine containing antiretroviral regimen
* CD4 cell count under 200per µL, plasma HIV RNA above 10000 copies per mL under antiretroviral therapy
* platelets under 50000 per µL and or abnormal coagulation tests
* pregnancy
* major or concomitant illness
Tretinoin in Treating Patients With Mycosis Fungoides or Sezary Syndrome

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of tretinoin in treating patients who have any stage mycosis fungoides or Sezary syndrome.

OBJECTIVES: I. Determine the efficacy of tretinoin (TRA) in patients with mycosis fungoides/Sezary syndrome. II. Evaluate the spectrum of toxicity of TRA in this patient population.

OUTLINE: Nonrandomized study. Single-agent Chemotherapy. Tretinoin, All-trans-Retinoic Acid, TRA, NSC-122758.

PROJECTED ACCRUAL: If 1 or more of the first 15 evaluable patients experience an objective response, then 20 additional patients will be entered. It is anticipated that the accrual rate will be 1-2 patients per month.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Biopsy-proven mycosis fungoides/Sezary syndrome Stage I-IV disease No CNS involvement At least 1 measurable lesion required (skin, lymph nodes, visceral lesion, or peripheral blood counts)

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-3 Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin no more than 2.0 mg/dL Transaminases no more than 2 x normal Alkaline phosphatase no more than 2 x normal Renal: Creatinine no more than 2.0 mg/dL Other: No active systemic infection No significant organ failure uncontrolled with medication No pregnant or lactating women Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior systemic therapy Chemotherapy: At least 4 weeks since prior topical chemotherapeutics or systemic therapy Endocrine therapy: At least 4 weeks since prior topical (including steroid) therapy or systemic therapy Radiotherapy: Not specified Surgery: Not specified
Myocardial Fibrosis Identification in Patients With Anthracycline-induced Cardiotoxicity

This is an interventional study for patients who had developed Anthracycline-Induced Cardiotoxicity (AIC) during or after anthracycline-containing therapy, referred to the Cardioncology Unit for heart failure treatment

The main aim of this interventional study is to evaluate biochemical and imaging markers of fibrosis in patients who had previously developed AIC during or after anthracycline-containing therapy.

Anthracycline-induced cardiomyopathy (AIC) is define as a reduction in Left Ventricular Ejection Fraction (LVEF) \>10% units from baseline and below 50%, assessed by echocardiography, during or after anthracycline-containing therapy.

All patients will undergo:

* at time 0

  * an echocardiogram with LVEF evaluation (biplane method)
  * a single blood sample.
* at time 1 - a Cardiac Magnetic Resonance (RMC) with contrast agent (T1 mapping technique) (time 1 = within 72 hours from blood sample).

Eligibility Criteria:
Inclusion Criteria:

* Patients who developed AIC during or after anthracycline-containing therapy assessed by LVEF valuation by echocardiography.

Exclusion Criteria:

* Age \<18 years
* Contraindications to contrast medium magnetic resonance imaging
Evolution of Maternal Weight During Pregnancy and Influence on the Endothelial Function in Her Offspring

The rising worldwide prevalence of obesity and its subsequently rising incidence of concommitant diseases as diabetes and cardiovascular events impose a defiant obstacle for the health care and associated health care costs of future generations. Obese pregnant women are a growing population of interest because their offspring is at risk for childhood obesity, an adverse metabolic and inflammatory profile and possible endothelial dysfunction. However, strong evidence is still lacking regarding the hypotheses on the early origin of these long-term health consequences.

Consequently there is no comprehensive data available on the contribution of changing maternal weight through lifestyle interventions or bariatric surgery and an eventual adverse metabolic and endothelial programming of the offspring.

The investigators of this study want to provide additional data on the body composition, metabolic and inflammatory state as well as endothelial function of children of obese pregnant women women and compare the outcome with children born from normal weight women. Furthermore, the investigators of this study will stratify the obese pregnant women into 3 groups: women who did not underwent an intervention, women who underwent a weight changing intervention during pregnancy e.g. diet or lifestyle intervention and women who underwent bariatric surgery before pregnancy. The overall aim of the study is to prove that in all the diverse groups of participating children, except the control group, there will be a certain grade of endothelial dysfunction, even if there was a normalization of weight, insulin sensitivity and inflammation before conception or delivery in the mother.


Eligibility Criteria:
Inclusion Criteria:

* Children of women who previously participated in different cohort studies conducted in Flanders concerning maternal obesity are included after contacting the mothers again. During the initial clinical trials the mothers were informed of possible follow-up studies on their offspring.

Exclusion Criteria:

* There are no absolute exclusion criteria formulated.
* For the peripheral pulse wave amplitude measurement we exclude children on growth hormone therapy.
* We postpone the examination for 2 weeks if there is an ongoing infection.
* We document the use of specific medication, but the use of it doesn't implicate exclusion of the participating children.
Multi Centre Trial of DSMM for Newly Diagnosed Multiple Myeloma up to 60 Years

The study is evaluating whether risk-stratification by the means of a chromosomal aberration provides a tool to discriminate between standard and high risk. Risk-adapted therapy is based on allogeneic stem-cell transplantation for high-risk subjects instead of a second autograft in patients with deletion of chromosome 13 who have an HLA-identical stem cell donor available.

The DSMM V protocol is to compare a consolidation treatment for standard-risk patients not displaying del(13) at initial diagnosis following two cycles of high-dose melphalan 200 mg/m² each supported by autologous stem cell retransfusion with interferon versus PEG-interferon. Patients with del(13) are screened for availability of a fully HLA-matched related or unrelated donor. If patient's informed consent is obtained additionally, he is scheduled to undergo an allogeneic SCT following the first cycle of high-dose melphalan. All other subjects are to proceed to a second course of high-dose melphalan similar to the standard-risk group. Initial cytoreduction is foreseen with four cycles of anthracycline-dexamethasone combination followed by combination therapy with ifosfamide/epirubicine/etoposide for stem-cell collection.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of multiple myeloma
* Salmon-and-Durie stage II or III
* Less than or equal to 60 years
* Signed informed consent

Exclusion Criteria:

* Relevant comorbidities
* Unable to adhere to study protocol
* Pregnancy
* Not received subject's informed consent
Evaluation of the Efficacy of Stiripentol (Diacomit) as Monotherapy for the Treatment of Primary Hyperoxaluria

Evaluation of the efficacy of stiripentol (Diacomit) as monotherapy for the treatment of primary hyperoxaluria.

Pilot clinical study, open, prospective and multicenter.


Eligibility Criteria:
Inclusion Criteria:

* Patient with primary hyperoxaluria type 1, 2 or 3, diagnosed according to standard methods
* Having at least one molar ratio \[oxaluria / creatinuria\] greater than 0.08 since diagnosis
* Having Glomerular Filtration Rate ≥ 45 mL / min / 1.73m2
* Age ≥ 6 months
* Having read, or whose parents have read, the information note and signed the consent form. For children, if their level of understanding allows, their assent will also be sought
* Proficient enough, or whose parents or legal representatives have sufficient mastery, the French language to read, understand and complete study documents
* Affiliate or beneficiary of a social security scheme
* Ability to respect the protocol, including treatment, and can be followed regularly in the study
* For pubertal patients, contraception deemed effective by the investigator or abstinence

Exclusion Criteria:

* Introduction, discontinuation or dose modification of vitamin B6 or potassium citrate treatment within 4 weeks prior to the inclusion visit
* Consumption of jelly candies and / or dark chocolate in the week preceding the study
* Patient having a kidney and / or liver transplant
* Presence of a clinically significant acute or chronic pathology, other than primary hyperoxaluria, that may interfere with the evaluation of the study results according to the investigator
* During biological or physical examinations, presence of significant anomaly (s) inconsistent with participation in the study according to the investigator
* History of severe allergy, asthma, skin rash or hypersensitivity to a drug
* Treatment affecting hepatic metabolism (cimetidine, ketoconazole, fluconazole, itraconazole, phenytoin, rifampicin, rifabutin) in progress or taken during the month preceding the start of the study
* Treatment affecting the renal tubule (probenecid, β-lactams, ...) in progress or taken during the last two weeks preceding the start of the study
* Presence of a pathology or treatment that, according to the investigator, renders the subject unfit
* Contraindications to stiripentol as defined in the current SmPC (hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC, history of psychosis in the form of delusional episodes)
* Pregnant or lactating woman
* Patient under guardianship
* Patient concurrently participating in another clinical trial or exclusion period following a previous trial
TVT Worldwide Registry

The objective of this observational study is to obtain long -term clinical and patient reported outcomes on the use of the GYNECARE family of TVT (Tension-Free Vaginal Tape) systems in women with stress urinary incontinence.

Sites may include patients with either the GYNECARE TVT SECUR System, GYNECARE TVT System, or the GYNECARE TVT Obturator System

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with SUI who are suitable candidates for a TVT system, as according the relevant Instructions for Use (IFU).
Platelet-Rich Plasma Therapy for Patellar Tendinopathy

The overall goal of this research is to find an effective treatment for patellar tendinopathy (PT). To achieve this, we will conduct a double-blinded randomized controlled trial to investigate if platelet-rich plasma is effective for treatment. Clinical (pain and function scores) and bio-mechanical (knee strength) measures will be correlated with disease modification changes assessed using conventional and novel quantitative magnetic resonance imaging (MRI) and ultrasound (US) techniques.

Sixty-six patients with PT will be randomized to one of three study arms. Subjects in Group 1 (PRP) will receive a single US-guided injection of 5 milliliters of autologous PRP into the patellar tendon, subjects in Group 2 (DN) will undergo ultrasound guided dry needling of the patellar tendon, and subjects in Group 3 (SH) will undergo a sham control ultrasound guided dry needling in the subcutaneous tissue only (not intratendon) at the level of the patellar tendon. The efficacy of the different treatment options will be assessed by pain- and function-dependent, PT-specific Victorian Institute of Sport Assessment Patella (VISA-P) quality of life scores, activity level scores, knee strength measurements, and conventional and novel MRI and US imaging at baseline, 16, 32, and 52 weeks post-treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 39 years
2. Chronic (\>3 months) PT
3. Clinical examination consistent with PT
4. MRI or US confirmation of PT
5. Pain score of 3 or greater on a 10-point visual analogue scale
6. Self-report failure of supervised physical therapy
7. Self-report failure of at least 2 of the most common treatment options for PT (e.g. NSAIDs, relative rest, ice and bracing).

Exclusion Criteria:

1. Inability to comply with study follow-up requirements
2. History of bleeding disorders or other hematologic conditions
3. Knee pain from other possible etiologies (e.g., degenerative joint disease, meniscal tear, ligament injury or reconstruction)
4. Full or partial patellar tendon tear
5. Current use of anticoagulation or immunosuppressive therapy
6. Prior knee trauma requiring medical attention or surgery
7. Worker's compensation injury
8. Daily opioid use for pain
9. Contraindication to MRI.
10. Systemic diseases such as Diabetes and connective tissue diseases.
11. Prior PRP or DN procedure.
12. Women that are pregnant
Presternal Magnesium With Bupivacain Versus Bupivacain Only for Postoperative Pain Relief in Open Heart Surgery

Effective pain relief after cardiac surgery has assumed importance with the introduction of fast track discharge protocols that requires early weaning from mechanical ventilation. Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of atelectasis, and prolongs recovery. Infiltration of local anesthetics near the surgical wound has shown to improve early postoperative pain in various surgical procedures.

Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in animal and human models of pain.

Effective pain relief after cardiac surgery has assumed importance with the introduction of fast track discharge protocols that requires early weaning from mechanical ventilation. Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of atelectasis, and prolongs recovery.

A major cause of pain after cardiac surgery is the median sternotomy particularly on the first two postoperative days.

The most often used analgesics in these patients are parenteral opioids which can lead to undesirable side-effects as sedation, respiratory depression, nausea, and vomiting.

Infiltration of local anesthetics near the surgical wound has shown to improve early postoperative pain in various surgical procedures.

Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in animal and human models of pain.

It has been mentioned in a systematic review that it may be worthwhile to further study the role of supplemental magnesium in providing perioperative analgesia, because this is a relatively harmless molecule, is not expensive and also because the biological basis for its potential antinociceptive effect is promising.

These effects are primarily based on physiological calcium antagonism, that is voltage-dependent regulation of calcium influx into the cell, and noncompetitive antagonism of N-methyl-D-aspartate (NMDA) receptors.

there is a need to evaluate and compare local magnesium with bupivacaine , in comparison to bupivacain

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years old
* American Society of Anesthesiologists physical status II and III
* Patients scheduled for open heart surgery with sternotomy

Exclusion Criteria:

* - Emergency surgery
* Clinically significant kidney or liver disease
* Patients allergic to local anesthetic
* Patients with prolonged CPB time (\>120 min)
* Patients required intra-aortic balloon pump
Photobiomodulation of Orthodontic Mini-implants by a 635nm Diode Laser

The study aimed to estimate clinically an influence of 635nm diode laser on the primary and secondary stability of orthodontic mini-implants placed in a maxilla, to assess mini-implants failure rate (mini-implant loss) and to evaluate a pain level after the treatment. The randomized clinical split-mouth trial included 15 subjects, 30 implants (Dual Top Anchor System, Seoul, Korea) with a diameter 1.4mm and length of 10mm. Mini-implants were placed in the area of the attached gingiva between the second premolar and first molar teeth 2 mm below the mucogingival junction of both sides of the maxilla in 15 patients.


Eligibility Criteria:
Inclusion Criteria:

* patients with class II malocclusion defect requiring lateral maxillary teeth distillation based on the use of orthodontic mini-implant;
* the patients were treated first time using fixed orthodontic appliance;
* no systemic diseases;
* were not using anti-inflammatory drugs;

Exclusion Criteria:

* had used antibiotics in the previous 24 months;
* smokers;
* had history of radiotherapy,
* taking bisphosphonate medication
A Phase 2 Study Using Aliya PEF Plus Pembro for Sarcoma

The is a phase 2 that will evaluate the efficacy and safety of the Aliya PEF ablation system combined with pembrolizumab, an immune checkpoint inhibitor.in advanced soft tissue sarcoma. Twenty subjects will be treated.

This is a Phase 2 study that will evaluate the efficacy and safety of the Aliya PEF ablation system plus pembrolizumab, an immune checkpoint inhibitor in advanced soft tissue sarcoma.

The AliyaTM System (Galvanize TherapeuticsTM) is a biphasic monopolar pulsed electric field (PEF) system that induces cell death in a manner independent of thermal processes, enabling focal ablation without denaturing stromal proteins or inducing significant muscle contraction. Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking indicated for various malignancies including melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell cancer, etc.Both Aliya and Pembrolizumab are FDA approved products.

Objectives:Primary: o evaluate progression free survival at 6 months; Secondary: To evaluate the objective response rate by RECIST v1.1 via CT scan or MRI at week 6 and every 6 weeks thereafter until end of treatment (EOT); to determine progression-free survival (PFS) at 6 months and overall survival, and to evaluate the incidence and grade of treatment related adverse events.

Exploratory: To evaluate PEF-Treated Dose-Response- Pre-PEF and follow-up as per standard of care after PEF energy delivery by RECIST v1.1 and iRECIST criteria, and to conduct biomarker analyses performed on tumor homogenate prep (THP) and lab blood draws collected at follow-up visits as per standard of care, which may include flow cytometry analyses of cell populations, cytokines, tumor-specific T-cell and B-cell populations, and tumor-specific IgG antibody quantities.The population to be studied include male and female subjects 18 years of age or older, of any ethnicity, with advanced soft tissue sarcoma.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female ≥ 18 years of age
* Pathologically confirmed diagnosis of pleomorphic sarcoma, myxofibrosarcoma, leiomyosarcoma, liposarcoma, synovial sarcoma
* Previously treated or untreated patients
* Measurable disease with at least one target lesion amenable to PEF
* Life expectancy at least 3 months
* Adequate hematologic, liver and kidney function
* ECOG performance status of 0-1
* Willingness to sign informed consent
* Negative pregnancy test if female

Exclusion Criteria:

* Patients with untreated CNS disease
* Anticancer therapy within 2 weeks
* Concurrent immunotherapy
* Pregnant women
* Autoimmune disorder
* Severe or uncontrolled systemic disease.
The Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia

There will be no significant differences in the efficacy and tolerability between the test and reference formulations of atorvastatin 20 mg in these Korean adults with primary hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* the patients aged 20 to 79 years with primary hypercholesterolemia that was not sufficiently responsive to therapeutic lifestyle changes and had LDL-C level over 100 mg/dL in high risk group.
* Inclusion criteria was in accordance with drug treatment guidelines; coronary artery disease or equivalent group with LDL-C ≥100 mg/dl; patients with two or more risk factors and LDL-C≥130 mg/dl; patients with 0 or 1 risk factor and LDL-C \>160 mg/dl after therapeutic lifestyle changes

Exclusion Criteria:

* therapy with any other investigational drug within 30 days of randomization,
* history of hypersensitivity to HMG-CoA reductase inhibitors,
* uncontrolled hypertension,
* poorly controlled diabetes (glycosylated hemoglobin \[HbA1c\] \>9%),
* unstable angina or presented with new-onset myocardial infarction (within 6 months),
* creatinine \>2.5 mg/dl,
* alanine aminotransferase (ALT) \>2 x upper limit of normal (ULN), aspartate aminotransferase(AST) \>2 x ULN, or creatine kinase (CK) \>2 x ULN,
* history of malignancy or psychosis;
* chronic liver disease,
* drug or alcohol abuse, pregnancy, breastfeeding, failure to practice adequate contraception, cyclical hormonal contraceptives or intermittent use of hormone replacement therapies.