cyrilzakka/clinical-trials huggingface dataset:
Randomized Controlled Trial to Test the Efficacy of Motivational Interviewing on Self-care

Introduction: Heart failure (HF) is characterized by an increasing prevalence and burden, representing a public health problem and a major cause of morbidity and mortality. Self-care is a cornerstone approach for optimizing therapy for patients with HF; patients play a key role in the management of their condition, given that several negative health outcomes might be avoided with effective self-care. Motivational interviewing (MI) has been described by the literature as highly favorable for treating chronic diseases, with promising results supporting its efficacy in enhancing self-care. Moreover, caregivers' availability constitutes a fundamental supporting factor among the strategies to improve self-care behaviors in people with HF.

Methods and analysis: This study protocol designed a prospective, parallel-arm, open-label, three-arm, controlled trial for purposing the aims to test the efficacy of a structured program including scheduled MI interventions in improving self-care behaviors among patients with HF at 3, 6, 9, and 12 months from the enrolment. Secondary aims comprehend the corroboration of the superiority of caregivers' participation to the structured program including scheduled MI interventions over the program administrated only to individual patients in enhancing self-care behaviors and other outcomes. Analyses will be performed within the framework of intention-to-treat (ITT). Comparisons between groups will be based on an alpha = 5% and two-tailed null hypotheses. In the case of missingness, analyzing the extent of the missingness and identifying underlying mechanisms and patterns will guide imputation methods.

Ethics and dissemination: The study protocol and template consent forms have been reviewed and approved by the Ethical Committee of San Raffaele Hospital (approval #74/INT). Also, the study protocol has been registered at ClinicalTrials.gov (Identifier: .......). Patients and caregivers will have to sign the informed consent forms before the randomisation. Patients and caregivers may leave the study at any time. The withdrawal from the study will not imply any prejudice, as fully documented and explained in the informed consent. Considering the open-access publication, the full protocol will be available freely.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years;
* diagnosis of HF with New York Heart Association (NYHA) Class II-IV;
* no acute coronary events within three months;
* consent to participate in the study;
* score ≤ 2 to at least two items of the Self-Care of Heart Failure Index 6.2 - SCHFI 6.2 at baseline;
* score on Six Item Screener \> 4;
* living at home;
* understanding of spoken and written Italian.

Exclusion Criteria:

* severe cognitive impairment (score 0-4 on the Six-item Screener);
* acute coronary events that occurred within three months;
* living in nursing homes or residential settings;
* caregivers unwilling to participate in the study.
Earlier Triggering in Rec-FSH/GnRH Antagonist Cycles

The effect of altering the timing of hCG administration on the ongoing pregnancy rate in patients stimulated with recombinant-FSH (rec-FSH)/gonadotrophin releasing hormone (GnRH) antagonists for in vitro fertilisation (IVF).

Progesterone elevation has been associated with prolongation of the follicular phase in GnRH antagonists cycles by two days after the commonly used criterion of the presence of at least three follicles of \>or= 17 mm has been met. Such an intervention is associated with significantly lower ongoing pregnancy rates in GnRH antagonist cycles, without an apparent deterioration of embryo quality.

The adverse effect of P elevation on the day of hCG administration might be explained by the induction of differences at the histological level as well as at the gene expression level between endometrial samples exposed to varying concentrations of progesterone (P). Prolongation of follicular phase by delaying hCG administration for two days is associated with a higher incidence of endometrial advancement on the day of oocyte retrieval in GnRH antagonist cycles (Kolibianakis et al., 2005). Moreover, Vaerenbergh et al., (2011) demonstrated a distinct difference in endometrial gene expression profile between patients with progesterone serum concentration above and below the threshold of 1.5 ng/ml on the day of HCG administration.

Due to the fact that earlier triggering of final oocyte maturation is expected to result in lower progesterone levels on the day of hCG administration it might be assumed that such an intervention might result in an improved probability of pregnancy by leading to a less deranged and more receptive endometrium.

The purpose of this randomized controlled trial is to evaluate whether triggering of final oocyte maturation as soon as ≥ 3 follicles ≥ 16mm are present on ultrasound or one day later affects the probability of pregnancy in patients stimulated with rec-FSH/GnRH- antagonists for IVF.

Eligibility Criteria:
Inclusion Criteria:- Age ≤ 39 years

* Body mass index between 18 and 29 kg/m²¬
* Presence of both ovaries
* Basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle
* Treatment with IVF/ICSI
* Embryo transfer on day 3 (1 or 2 embryos)
* Patients can enter in the study only once

Exclusion Criteria:

* Presence of endometriosis stage ≥3(AFS)
* Polycystic ovarian syndrome (Rotterdam criteria)
* Need for preimplantation genetic diagnosis (PGD)
* Azoospermia testicular sperm extraction (TESE)
Safety and Efficacy of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration

This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of age-related macular degeneration in at least 1 eye
* Best corrected visual acuity of 20/40 to 20/320 in the study eye
* Best corrected visual acuity of 20/200 or better in the non-study eye

Exclusion Criteria:

* History of vitrectomy, macular surgery, or glaucoma surgery in the study eye
* Cataract or refractive surgery in the study eye within the last 3 months
Biological and Clinical Measurements Following Systemic Leakage When a Citrate or Heparin Lock is Used

In the VERROUREA study, there were two cases of an abnormal increase in TCA. In theory no leakage of the lock into the bloodstream should have been seen. Lock leakage could have particularly serious, and especially clinical, repercussions in these patients who already have a high risk of haemorrhage given the numerous associated comorbidities. The aim of this study is to investigate the leakage of locks into the bloodstream by measuring, before and after injection of the lock, the evolution of haemostasis tests and calcaemia. The findings will complete safety data already collected in the VERROU REA study.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged \> 18 years
* Requiring dialysis for acute kidney failure
* In whom a first non-tunnelled catheter has been inserted
* In the jugular or femoral position
* Once informed consent has been obtained from the patient, a family member or a person of trust

Exclusion Criteria:

* Patients with active and poorly-controlled bleeding
* Known allergy to citrate
* Liver failure (Factor V \<30%)
* Thrombopenia \< 30 000/mm3 in the absence of planned corrective measures at the time of randomization
* Known or suspected heparin-induced thrombopenia
* Positive blood cultures without treatment or with inappropriate treatment at the time of randomization
* Catheter inserted in the subclavian position
* Person without national health insurance cover
* Pregnant women
* Adults under guardianship
Applying PET/MR in Rectal Cancer.

The use of the novel recently introduced PET/MR scanner is believed to be promising in RC management, providing great anatomical details and detailed metabolic characterization. Preliminary data indicate it may become a strong imaging modality for staging of RC and has the potential to be used as a predictive tool guiding individualized therapy in patients receiving nT, but confirmation on prospective studies is mandatory. The use of radiomics as analysis approach may assist in achieving a better understanding of the obtained image data, and thus a more accurate disease assessment.

Objectives

1. To preliminary assess the potential diagnostic value of single PET/MR scan in RC staging and compare it to that of MRI alone, PET/CT alone, and combined MRI and PET/CT.
2. To preliminary assess the potential value of PET/MR in predicting pMR to nT.
3. To use radiomics analysis of PET/MR data to develop a quantification clinical tools that allow a more accurate and comprehensive assessment of RC patients.


Eligibility Criteria:
Inclusion Criteria:

1.Patients with newly diagnosed RC; histopathological confirmation of adenocarcinoma of colorectal origin.

Exclusion Criteria:

1. Patients younger than 18 years;
2. pregnancy;
3. other known active malignancy;
4. previous chemotherapy or radiotherapy;
5. previous pelvic operation;
6. patient that no intent / not suited for neoadjuvant therapy (including metastatic disease at presentation); contraindication to intravenous contrast agents.
Improving Hospitalizations for Children With ASD

This study aims to implement and test a specific brief Applied Behavior Analysis model for assessing and responding to severe challenging behavior during acute medical and behavioral hospitalization for children with ASD. The investigators will evaluate the impact of this program by conducting a randomized trial across both medical and psychiatric hospital settings.


Eligibility Criteria:
Inclusion Criteria:

* documented diagnosis of an ASD based on clinical DSM-5 diagnostic criteria assessed by attending psychiatrist
* the presence of a significant challenging behaviors (e.g., aggression, property destruction, self-injury, elopement)
* admission to the VPH or medical floors
* individual and caregiver agreement to participate and ability to provide informed consent (and assent).

Exclusion Criteria:

* None
Safety and Efficacy Study to Compare a 4% Dimethicone Foam and Nix Cream Rinse (1% Permethrin) in the Control of Head Lice

The purpose of this study was to evaluate the efficacy of a dimethicone foam in the control of head lice and to compare the efficacy to a permethrin based product.


Eligibility Criteria:
Inclusion Criteria:

* 4 - 85 years of age
* active head lice infestation of at least ≥ 10 live lice
* short hair (hair no longer than 2 inches below the neck) or long hair (hair 2 inches below the neck to mid back)

Exclusion Criteria:

* had received or used an investigational new drug within the 30 days immediately preceding the study
* used any form of head lice treatment whether prescription, over-the-counter, or a home remedy for at least fourteen days prior to their study visit
* used topical medication of any kind on the hair for a period of 48 hours prior to the visit
* had a history of allergy to rag weed, permethrin, or mineral oil, or had taken trimethoprim or cotrimoxazole at evaluation or during the previous four weeks
* Female subjects that were pregnant or breast feeding
Acupuncture for Recovery and Postoperative Nausea and Vomiting After Middle Ear Surgeries

Modern surgery management needs increasing operating room turnover and more ambulatory surgery. In order to come over this challenge, the recovery needs to be optimized. Enhancing recovery could be achieved by preventing postoperative pain and postoperative nausea and vomiting. Middle ear surgery is a common ambulatory surgery with increasing occurrence of postoperative nausea and vomiting.

Sample size: as percent of vomiting following acupuncture and following standard anesthesia is 0.13% and 29.2% respectively so sample size is 58 (29 in each group). Sample is calculated using open epi program with confidence level 95% and power 80%.

Patients in Group C (control group) (n=29): will receive no treatment. While patients in Group A (Acupuncture group) (n=29): will receive needle acupuncture.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from the patient.
* Age: 21-60 years old.
* Sex: both sex (males or females).
* Physical status: ASA 1\& II.
* BMI = (20-30 kg/m2).
* Type of operations: elective unilateral middle ear surgeries such as tempanoplasty, stapedectomy and mastedictomy.

Exclusion Criteria:

* Altered mental state
* Patients with Drug abuse or alcohol.
* Patients with on antipsychotic drugs, regular antiemetic therapy or receiving antiemetic 24 hour before surgery.
* Patients with pre-treatment with acupuncture or trigger point injection.
* Pregnancy.
Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery

The purpose of this study is to evaluate the health cost and clinical outcome by introducing enhanced recovery (ERAS) compared to conventional recovery in colorectal surgery.

Aim of the sudy:

1. Clinical evaluation: To investigate if patients treated with enhanced recovery have a shorter hospital stay and less morbidity than the patients treated conventionally. Other clinical questions witch might be answered in this study are clinical surgical stress response (insulin resistent), amount of analgetics used and time to normal activity.
2. Evaluation of quality of life: Instruments used in this sudy to evaluate quality of life are 15 D and qualitative interview.
3. Economic evaluation: Cost-utility analysis of the clinical studies
4. Compare patients who received a fast track program with dedicated fast track- and stoma nurse specialist and special focus on counselling and stoma education, compared with patients receiving existing current practice of stoma-education in a traditional care pathway, could reduce the length of hospital stay, readmission and stoma related complications
5. Further we will tray to generate additional insights into the impact of counselling when groups of patients are otherwise equal in terms of fast-track criteria. We are therefore continuing the enrolling of our colorectal patients in which both study arms contain the same ERAS items; the arms will only differ in terms of perioperative information and guidance as well as follow-up by dedicated nurses.

Eligibility Criteria:
Inclusion Criteria:

* Planed elective colorectal surgery, written consent and age above 18 years

Exclusion Criteria:

* Patients below 18 years, pregnancy, surgical emergency and no informed consent
Combined Spinal-epidural Versus Spinal Analgesia for Elective Caesarean Section in the Postoperative Period

Combined spinal epidural (CSEA) and single shot spinal anesthesia (SSSA) are both well-established anesthetic methods for caesarean section. CSEA combines the advantages of spinal anesthesia for the surgery, and epidural anesthesia for postoperative pain management. The aim of this randomized trial was to compare analgesia and patient satisfaction with CSEA continuous epidural administration of local anesthetics versus SSSA with oral pain medication in the postoperative period.

Combined spinal epidural (CSEA) and single shot spinal anesthesia (SSSA) are both well-established anesthetic methods for caesarean section. CSEA combines the advantages of spinal anesthesia for the surgery, and epidural anesthesia for postoperative pain management. However, it is more time-consuming, and adds potentially risks of both single techniques.

The aim of this randomized trial was to compare analgesia and patient satisfaction with CSEA continuous epidural administration of local anesthetics versus SSSA with oral pain medication in the postoperative period.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists-physical status: I or II
* elective caesarean section

Exclusion Criteria:

* age under eighteen
* maternal systemic diseases
* allergies against the drugs used
* systemic infection or local infection in the puncture area
* dysfunctional coagulation
* coagulation-inhibiting drugs
Pain During Injection With Botulinum Toxin in Post-stroke Spasticity Treatment

The aim of the study was to analyze which step of the procedure of toxin botulinum injection is the most painful between skin break-in, electric stimulation, injection and needle withdrawal.

Post-stroke spasticity management by botulinum toxin injections may be limited by pain or discomfort at the injection side.

Particularly tracking by electrostimulation, but also skin puncture, toxin injection or needle withdrawal may be painful.

The objective of this study is to define an individual injection strategy in order to limit pain.

Eligibility Criteria:
Inclusion Criteria:

* stroke
* severe upper or lower limb spasticity (Ashworth score ≥ 2 for at least one muscle)
* patients requiring a treatment by botulinum toxin
* patients refusing analgesia for injections.

Exclusion Criteria:

* severe aphasia (severity subscore of the BDAE \<3)
* cognitive impairment or psychiatric disease altering the reliability of pain evaluation
* patient medically unstable.
Validation of the GATE Software

Comparison of the differential luminance sensitivity (DLS) values at each test point


Eligibility Criteria:
Inclusion Criteria:

* physical, intellectual and linguistic abilities, in order to understand the test requirements
* spherical ametropia max. ± 8 dpt, cylindrical ametropia max. ± 3 dpt
* distant visual acuity \> 10/20
* isocoria, pupil diameter \> 3 mm

Exclusion Criteria:

* pregnancy, nursing
* diabetic retinopathy
* asthma
* HIV+ or AIDS
* history of epilepsy or significant psychiatric disease
* medications known to effect visual field sensitivity
* acute ocular infections (e.g. keratitis, conjunctivitis, uveitis)
* severe dry eyes
* miotic drugs
* amblyopia
* squint
* nystagmus
* albinism
* keratoconus
* intraocular surgery (except for uncomplicated cataract surgery) performed \< 3 month prior to screening
* history or presence of macular disease and / or macular edema
* relevant opacities of central refractive media (cornea, lens, vitreous body)
* ocular trauma
Exploration and Determination of Genomic Markers Predictive of Uterine Atony

The primary objective of this study is to determine whether there are markers in the tissue of atonic uteri, and in the patients' plasma that would help identify patients likely to suffer postpartum hemorrhage due to uterine atony. We also will attempt to identify the cause(s) of uterine atony that might suggest mechanisms to prevent and manage it.

Patient will be recruited from those admitted to our Labor and Delivery unit. Ten women will be the control subjects, and these will be selected from patients who are admitted for scheduled cesarean delivery. Ten women will be selected from women who develop uterine atony either following cesarean delivery, or postpartum patients who delivered vaginally but subsequently required surgical management of uterine atony (hysterectomy or uterine saving surgery). From each patient a small amount of uterine muscle will be excised and placed in a fixative, preservative transport medium. Ten cubic centimeters of blood will be drawn from each patient to accompany the tissue. The tissue and blood will be processed and analyzed to identify differences in the tissue and plasma of messenger RNA, micro RNA, long non-coding RNA, and DNA methylation in normal and atonic uterine patients. Statistical analysis of these markers will be performed to determine whether there are significant differences in their expression. It is hoped that differences will be discovered that may be used diagnostically to predict uterine atony, and differences that may suggest the etiology of uterine atony.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* female
* pregnancy over 23 weeks gestation

Exclusion Criteria:

* under 18 years of age
* prisoners
* non-female sex
* cannot provide informed consent
Transcranial Direct Current Stimulation (tDCS) and Hallucinations in Schizophrenia

The purpose of this study is to determine whether trans Direct Current Stimulation (tDCS) is effective in the treatment of auditory hallucinations in schizophrenia.

The project will investigate the use of a novel technique, transcranial direct current stimulation (tDCS) in the treatment of patients with schizophrenia. tDCS permit the application of an extremely weak continuous electrical current to the brain through an anode and a cathode applied on the scalp. Anodal stimulation appears to increase brain activity whereas cathodal stimulation has the opposite effect.

Using anodal \& cathodal tDCS the investigators aimed to treat auditory hallucinations, a symptoms of schizophrenia. The investigators plan to apply tDCS such that it can simultaneously increased activity in the frontal brain areas and reduce activity over temporoparietal cortex, 2 areas involved in the physiopathology of the disease. Real active stimulation will be compare to a sham condition in 60 patients (30 in each group). 30 patients will be included in a French center (Hospital le Vinatier, sponsor of the study) and 30 in Tunisia (laboratory "vulnerability to psychosis" (Pr Gaha) à Monastir).

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia according to Diagnostic and Statistical Manual - DSM-IV
* Auditory verbal hallucinations for at least 6 weeks (despite antipsychotic drugs)
* Medication Resistance according to Kane et al., 1988
* Age between 18 and 50 years old
* Informed consent

Exclusion Criteria:

* Concomitant major and unstable medical or neurologic illness
* Pregnant