cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Clinical Treatment of Multiple Myeloma Based on Multi-omics

With the emergence of new drugs, the short-term survival rate of multiple myeloma has been significantly increased. However, in clinical treatment, doctors found that different patients may present different clinical efficacy and adverse reactions when using standard treatment. Some studies have shown that gene and metabolic differences in patients with multiple myeloma may be an important factor affecting clinical efficacy.

In this project, peripheral blood samples and bone marrow from patients with multiple myeloma will be studied by using the methods of genomics, proteomics, metabonomics and transcriptomics. It is expected to find biomarkers and genes related to clinical efficacy, adverse reactions, and blood concentration of bortezomib in peripheral blood samples. If the sample size is large enough, the project team expects to establish a prediction model for the efficacy and safety of bortezomib containing regimen for multiple myeloma patients through the above studies. Investigators hope that the evaluation system can provide a reference for clinical formulation of appropriate drug delivery scheme.


Eligibility Criteria:
Inclusion Criteria:

* exposure group:

  1. Patients diagnosed with multiple myeloma.
  2. Patients with fluorescence in situ hybridization report results, and try to obtain genetic diagnosis results.
* healthy control group: Patients diagnosed without multiple myeloma, such as other chronic diseases or blood tumors.

Exclusion Criteria:

1. Patients without complete clinical information.
2. Patients with malignant epidemic diseases.
3. Patients with alcohol abuse or special dietary habit .
4. Patients with digestive system diseases, such as inflammatory bowel disease, intestinal infectious disease or other diseases that may affect digestive system function.
5. Patients with a history of gastrointestinal operation.
6. Patients with severe renal insufficiency without regular dialysis.
7. Patients with other possibilities who has severe liver or kidney function injury without intervention.
Human Papilloma Virus Vaccination in Girls With Cystic Fibrosis (VACCIN-HPV-MUC2)

Background The main risk factor for cervical cancer is the infection by human papillomavirus (HPV). Vaccination against HPV, offered to all girls aged 11 to 14 is an effective method of prevention against cervical pathology. Despite this, vaccination coverage against HPV remains low in France. A proportion of women with cystic fibrosis may be involved in transplantation, a factor associated with a higher risk of HPV carriage and cervical pathology. An over-risk of cervical pathology would also be present in women with non-transplanted cystic fibrosis. Particular attention to vaccination should therefore be included in this population.

Objectives of the study The main objective of the study is to estimate the frequency of HPV vaccination in young girls with CF over 9 years and followed in a pediatric CF center.

The secondary objectives are to know:

* The type of vaccine used (bivalent / quadrivalent / nonavalent)
* The proportion of vaccinated girls with respect of the vaccination schedule (number of injections / spacing between doses)
* Reasons for non-use of vaccination

Study design The study will last 12 months. It is a cross-sectional, non-interventional, multicenter conducted by self-administered questionnaire.

Population

* young girls aged 9 years or older with Cystic fibrosis
* Followed in a pediatric or mixed CF center in the France (Rhone-Alpes Auvergne Region and Ile de France Region)
* With parents who did not object to participation in the study

Number of subject: 62 patients

Expected results

* Knowledge of HPV vaccination coverage in young girls with CF.
* Sensitization of patients, their parents and health professionals to HPV vaccination. Understand the barriers and reasons for refusing vaccination to promote actions to improve immunization coverage.


Eligibility Criteria:
Inclusion Criteria:

* young girls aged 9 years or older
* patients with Cystic Fibrosis
* patients followed in a pediatric or mixed CF center in the France (Rhone-Alpes Auvergne Region and Ile de France Region)
* patients with parents who did not object to participation in the study

Exclusion Criteria:

-patients who refuse to answer to the self-administrated questionnaire
Usefulness of Markers to Predict Recurrence of Atrial Fibrillation After Radiofrequency Catheter Ablation

Catheter ablation using radiofrequency is a new therapeutic tool to treat atrial fibrillation with a higher success rate than medical therapy (80% versus less than 50% respectively). Because of the length of the intervention and of the risk of complications of the procedure, it would be important to determine success rate before the intervention. The information gained from this study will in all probability improve our estimation of the chances of a successful intervention and may enable us to take necessary therapeutic measures in case of an elevated risk of recurrence.

Multiple studies suggest that the 2 markers in this study could provide information of this nature, however, their utility in the radiofrequency catheter ablation treatment of atrial fibrillation has never been demonstrated.

Catheter ablation of atrial fibrillation is a recent therapeutic tool to treat atrial fibrillation. The success rate of eliminating atrial fibrillation by radiofrequency catheter ablation is 80 %, after one or sometimes two procedures, against 20-50 % with drug treatment.

This intervention may be complicated by : hematoma at the puncture site - 1 % incidence; thromboembolic events \< 1 % incidence; cardiac perforation with tamponade \< 1 %, pulmonary vein stenosis 2 % incidence.

The aim of this study is to evaluate blood tests of biological products (NT-proBNP and CRP) as markers of prognosis and success after radiofrequency catheter ablation for atrial fibrillation.

Previous studies demonstrated the prognostic value of NT-proBNP and CRP in the recurrence of atrial fibrillation after electrical cardioversion. However the prognostic value of these biomarkers was never demonstrated in the setting of radiofrequency catheter ablation of atrial fibrillation.

This is an observation study including 180 patients with the indication of catheter ablation for atrial fibrillation. Confounding factors of increased NT-proBNP will be assessed with echocardiographic imaging.

Eligibility Criteria:
Inclusion Criteria:

* atrial fibrillation
* indication for catheter ablation of atrial fibrillation

Exclusion Criteria:

* significant valvulopathy
* previous catheter ablation for atrial fibrillation or atrial flutter
* left ventricular ejection fraction \< 30%
* Severe heart failure (NYHA IV)
* Severe enlargement of left atrium (\> 55mm)
Platelet Rich Fibrin+1% Alendronate in Treatment of Chronic Periodontitis

The present study is designed to evaluate the combined efficacy of Platelet Rich Fibrin (PRF) and 1% Alendronate (ALN) with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis patients.

Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate, act as reservoirs of growth factors and cytokines which are the key factors for regeneration of the bone and maturation of the soft tissue. Alendronate (ALN), a potent member of bisphosphonate group is known to promote tissue regeneration by inhibiting osteoclastic bone resorption and promoting osteoblastogenesis. The present study was designed to evaluate the combined efficacy of PRF and 1% ALN with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis patients.

Methods: Ninety patients with single defects were categorized into three groups: OFD alone, OFD with PRF,OFD with PRF+1% ALN. Clinical parameters; site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level (CAL) and gingival marginal level (GML) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic intra-bony defect depth reduction (IBD) was evaluated at baseline and 9 months.

Eligibility Criteria:
Inclusion criteria

* Presence of 3-wall IBD ≥3 mm deep (distance between alveolar crest and base of the defect on an Intra-oral Periapical Radiograph \[IOPA\]) along with an interproximal probing depth (PD) ≥5 mm after phase I therapy (scaling and root planing\[SRP\]) in asymptomatic teeth.

Exclusion Criteria:

* Aggressive Periodontitis patients;
* Systemic conditions known to affect the periodontal status;
* medications known to affect the outcomes of periodontal therapy;
* Hematological disorders and insufficient platelet count (\<200,000/mm3);
* Pregnancy/lactation;
* Smoking and tobacco use in any form
* Immunocompromised individuals.
* Those having unacceptable oral hygiene (plaque index27 \[PI\] \>1.5) after reevaluation of Phase I therapy .
* Teeth with furcation involvement, non-vital teeth, carious teeth indicated for restorations and mobility of at least grade II were also excluded.
Assessment of Early Changes in SD-OCT After Initiation of a Treatment by Intravitreal Aflibercept (EYLEA®)START

Aflibercept (EYLEA®) induces a rapid reduction in central retinal thickness (CRT) for patients suffering from neovascular age-related-macular degeneration.1 This early dramatic reduction in CRT is already observed through week 4. Therefore it might be not necessary to consistently perform each of the three monthly consecutive intravitreal injections of the so-called loading phase.

The aim of this study is to assess whether the retina of some patients has dried up after the first or second intravitreal injection of Aflibercept (EYLEA®) 2mg and in that event, to determine the proportion of these patients The analysis of the characteristics could help identify a morphotype that would predict whether and when the retina will dry up within the first 3 months of treatment. For some patients having an early drying-up, the third monthly injection might be not necessary 50 naïve patients will be included and will receive a monthly injection over 12 weeks with a biweekly follow-up. Morphological and functional characteristics will be recorded at each visit and will be analyzed. The rate of patients with dry SD-OCT will be assessed.

The study includes 7 visits. The visits are scheduled on an every 2-week basis from baseline to Week 12. V1 (baseline), V3 and V5, the patient will be injected with Aflibercept (EYLEA®) 2mg. In the other visits, the visual acuity test, Fundus photography, SD-OCT, and/or Fluorescein Angiography are performed

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 50 years of age
* Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD including juxtafoveal lesions that affects the fovea as evidenced by FA in the study eye
* Signed Informed Consent
* Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.

Exclusion Criteria:

* Prior treatment with anti-VEGF therapy in the study eye
* Active or suspected ocular or periocular infection.
* Active severe intraocular inflammation
Sensory Modulation Dysfunction and Posttraumatic Stress Disorder

To explore the role of sensory modulation dysfunction (SMD) (i.e., a neurodevelopmental state altering the sensory perception, severely interfering with daily function) as a risk factor for posttraumatic stress disorder (PTSD), its co-occurring pain, and impeded cognitive functions, following exposure to combat trauma.

Background and Aim: Posttraumatic stress disorder (PTSD) is interwoven with chronic pain, and the latter co-occurs with sensory modulation dysfunction (SMD). Moreover, SMD was found as a risk factor for chronic pain and hampered executive functioning. Currently, the sensory domain is neglected in the PTSD research realm, though findings indicate its link to PTSD. Thus, this study proposes to bridge a current gap in PTSD knowledge base, and specifically, our general aim is to uncover the role of SMD in predicting combat trauma-related symptomatology, altered executive function, and clinical pain.

Methods: This is a single-blind randomized control study, comprising 4 assessments: pre (T1); post (T2); 10 (T3); and 40 (T4) days follow-up, following experimental manipulation (see Figure 1). Participants with and without SMD will be randomly allocated to experimental and control groups that will watch traumatic movie scenes simulating combat and non-traumatic movie scenes, respectively. The assessor will be blinded to group allocation.

Population: One-hundred healthy individuals aged 18 to 28 years, with and without SMD. Participants with SMD will be identified via a standardized questionnaire during screening. The sample size was calculated based on power analyses via G\*Power 3 software derived from p-value of .05 and statistical power of .80.

Tools: Both objective and subjective outcome measures will be applied consisting of self-report questionnaires, psychophysical-, physiological-, emotional reactions, and executive function performance-based- testing will be applied. The experimental manipulation will comprise of the Trauma film paradigm.

Expected Results: Findings may advance the understanding of PTSD development and thus not only serve in attenuating the risk for PTSD among combatants but also may contribute to developing preventative measures for PTSD among combatants.

Eligibility Criteria:
Inclusion Criteria:

* Intact or corrected vision
* Proficiency in Hebrew
* Exclusion Criteria:
* Neurological disorders
* Psychiatric disorders
* Neurodevelopmental disorders
* Substance use disorder
* Chronic pain
* Regular intake of medications.
* Cultural and societal backgrounds that might bias participant reaction to study protocol (i.e., nationality)
Efficacy of a Multi-faceted Intervention Combining an Educational Outreach Visit to General Practitioners and Patient Education Material to Deprescribe Proton Pump Inhibitors (PPI): a Population-based, Pragmatic, Cluster-randomized Controlled Trial

Deprescribing is defined as "the process of withdrawal of an inappropriate medication, supervised by a health care professional with the goal of managing the polypharmacy and improving outcomes". Inappropriate use of proton pump inhibitors (PPI) is associated with severe adverse drug reactions and a major economic impact. Deprescribing should be considered when inappropriate prescription of PPI is identified.

DeprescrIPP DAM is a pragmatic trial, population-based, designed in clusters. It wil assess the efficacy of a multi-faceted intervention (an educational outreach visit to general practitioners associated with the sending of patient education material to their patients) to deprescribe PPI.


Eligibility Criteria:
Inclusion Criteria:

* General practitioners (GP)

  • All GP settled in the French region Pays-de-la-Loire having seen more than 100 different patients in the year before baseline, will be eligible.
* Patients

  * Aged more than 18 years old
  * Affiliated to the French health insurance CPAM
  * Treated with PPI\> 300DDD/year in the year before baseline (estimated with reimbursement databases).
  * Whose GP is included in the study

Exclusion Criteria:

* General practitioners (GPs) :

  • Participation refusal
* Patients

  * Participation refusal
  * Patients at risk of gastroduodenal lesions i.e. treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and over 65 years old or treated with either corticosteroids or anticoagulants or platelet aggregation inhibitors
  * Patients under legal protection
Study to Evaluate the Effect of Coadministered Erythromycin on the Pharmacokinetics and Safety of Padsevonil

The purpose of this study is to evaluate and compare the Pharmacokinetics (PK) of concomitant administration of Padsevonil (PSL) in the presence and absence of erythromycin in healthy study participants.


Eligibility Criteria:
Inclusion Criteria:

* Study participant is male or female and between 18 and 55 years of age (inclusive)
* Study participant is of a body weight of at least 50 kg for males and 45 kg for females, as determined by a body mass index (BMI) between 18 and 30 kg/m\^2
* Female study participants use an efficient form of contraception for the duration of the study (unless menopausal). Hormonal contraception may be susceptible to an interaction with the Investigational Medicinal Product (IMP), which may reduce the efficacy of the contraception method. The potential for reduced efficacy of any hormonal contraception methods requires that a barrier method (preferably male condom) also be used
* Study participant has clinical laboratory test results within the local reference ranges or values are considered as not clinically relevant by the investigator and approved by the UCB Study Physician
* Study participant has Blood Pressure (BP) and pulse rate within normal range in supine position after 10 minutes of rest
* Male study participant agrees that, during the study period, when having sexual intercourse with a woman of childbearing potential, he will use an efficient barrier contraceptive (condom plus spermicide) AND that the respective partner will use an additional efficient contraceptive method

Exclusion Criteria:

* Study participant has previously received Investigational Medicinal Product (IMP) in this study
* Study participant has participated in another study of an IMP (or a medical device) within the previous 3 months before Screening (or within 5 half-lives for the IMP, whichever is longer) or is currently participating in another study of an IMP (or a medical device)
* Study participant has a history of drug or alcohol dependency within the previous 6 months or tests positive for alcohol (breath test) and/or drugs of abuse (urine test) at the Screening Visit or at any time during confinement
* Study participant has made a blood or plasma donation or has had a comparable blood loss (\>400 mL) within the last 3 months prior to the Screening Visit
* Study participant smokes more than 5 cigarettes per day (or equivalent) or has done so within 6 months prior to the Screening Visit
* Study participant is taking any concomitant medication currently or within 2 weeks prior to the first day of dosing with the exception of paracetamol (acetaminophen)
* Study participant has any clinically relevant Electrocardiogram (ECG) finding at the Screening Visit or confinement
* Study participant has a history within the last 5 years or present condition of malignancy, with the exception of basal cell carcinoma
* Female study participant tests positive for pregnancy, plans to get pregnant during the participation in the study, or who is breastfeeding
A Study of RO4917523 in Patients With Fragile X Syndrome

This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4917523 in adolescent and adult patients with fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of RO4917523, or matching placebo once daily. The anticipated time on study treatment is 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult and adolescent patients, 14-50 years of age
* Diagnosis of fragile X syndrome with a confirmed fragile X mental retardation 1 (FMR1) full mutation and qualifying scores on the Aberrant Behavior Checklist (ABC) and CGI-S
* Patients must agree to either remain completely abstinent or to use two effective contraceptive methods during and 3 weeks after the study

Exclusion Criteria:

* Previous treatment with another metabotropic glutamate (mGLU) receptor antagonist within 18 months or with RO4917523
* Participation in a clinical trial involving an investigational (unapproved) drug within 3 months or 5 times the half-life (whichever is longer) before start of this study
* Any uncontrolled, unstable clinically significant psychiatric condition other than fragile X syndrome
* History of suicidal behavior
Evaluation of Technologies for Neonates in Africa

This is a diagnostic accuracy evaluation and clinical feasibility study of investigational devices (EarlySense and ANNE systems) in a neonatal high dependency unit (nHDU) in a private teaching hospital and a government maternity hospital in Nairobi, Kenya. Neonates who are admitted for routine observation and care will be enrolled.

To further reduce neonatal mortality rate in low resource settings (LRS) in Africa, research is needed to develop and optimize innovations in neonatal care, specifically technologies that are low cost, operator-independent, and highly efficient. The purpose of this study is to produce information and data regarding the performance of two existing multiparameter continuous physiological monitoring devices developed by device developers, EarlySense and Sonica. The clinical trial is intended to provide evidence to establish whether these investigational devices can reliably and accurately measure vital signs in neonates (when compared to verified reference devices) and to assess the feasibility, usability and acceptability of these devices for use in neonates in a LRS in Africa.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female neonate, corrected age of ≤ 28 days.
2. Willingness and ability of neonate's caregiver to provide informed consent and to be available for follow-up for the planned duration of the study.

Exclusion Criteria:

1. Receiving mechanical ventilation or continuous positive airway pressure (CPAP).
2. Skin abnormalities in the nasopharynx and/or oropharynx.
3. Contraindication to application of skin sensors.
4. Known arrhythmia.
5. Presence of a congenital abnormality requiring major surgical intervention.
6. Any medical or psychosocial condition or circumstance that, in the opinion of the investigators, would interfere with the conduct of the study or for which study participation might jeopardize the neonate's health.
Effect of Neural Mobilization on Lumbosacral Radiculopathy Patients With Peripheral Sensitization

The primary purpose of this study was to investigate the effects of slider and tensioner techniques on pain, hip and knee ROM in lumbosacral radiculopathy patients with peripheral sensitization. A secondary purpose was to evaluate the correlation between these outcomes measurements.

Study design: Double-blind case-control trial. Methods: Fifty-one male lumbosacral radiculopathy patients with peripheral sensitization, were divided into one of the three groups: slider, tensioner, and control. The primary outcome measurements were visual analog scale (VAS) for pain, hip range of motion (ROM) during SLR test, and knee flexion ROM during slump test. The measurements were taken at baseline, after 1st, 3rd, and 6th session.

Statistical Analysis: A two-way mixed design analysis of variance (MANOVA) with post-hoc (Bonferonni Correction) was used to calculate the differences with Time (baseline, 1st,3rd,6th sessions) as a within-group factor and Group (control, slider, and tensioner) as a between-group factor. The effect size was calculated with Cohen's d. Pearson's correlation was used for correlation analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with lumbosacral radiculopathy with dominant peripheral sensitization
* patients with unilateral leg pain.
* patient S-LANSS score \> 12,
* negative sensory and motor examination.
* positive neural tissue provocation tests (straight leg raising test, slump test).
* adult.
* pain duration of more than 3 months.

Exclusion Criteria:

* S-LANSS score ≥ 12,
* motor or sensory deficits,
* history of back or lower extremity surgeries,
* bilateral referred pain,
* patients with pacemakers, cardiovascular problems, epilepsy, active malignancy, dermatological conditions, and diminished pain sensation.