cyrilzakka/clinical-trials huggingface dataset:
Intravitreous Bevacizumab and Standard Metabolic Control for Diabetic Macular Edema - A Contrast Sensitivity Study

To evaluate the effects on contrast sensitivity (CS) measurements of intravitreal bevacizumab injections associated with standard metabolic control in eyes with diabetic macular edema (DME) associated with standard metabolic control.

Prospective, randomized, masked and interventional study. Patients with diabetes mellitus (DM) 2, glycated hemoglobin (HbA1c) less than 11% and previously treated macular edema three months before will be randomized in two groups. The baseline examination consisted of visual acuity (VA), CS using the Pelli-Robson Charts, optical coherence tomography (OCT) and Fluorescein Angiography for all eyes.

The same tests will be repeated above, in both groups, again, in the week 2,6 and 12, when the data is then collected for analysis and so ended the closed phase. On the same day will start the open phase, which will be applied intravitreal injection of bevacizumab in both groups and the same tests of closed phase will be held in the week 14,18 and 24 when the study will be completed then \[Table 1\] .

Patients will be monitored and controlled clinically including blood pressure measurements, laboratory blood tests such as blood glucose, glycated hemoglobin, urea, creatinine, total cholesterol and fractions.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years old, of both genders;
* Patients with diabetes mellitus type I or type II;
* Macular edema presence of clinically significant diabetic in their mixed or diffuse;
* Visual acuity worse than 20/40 corrected (\< 68 letters ETDRS)
* Glycated hemoglobin ≤ 11%;
* Systolic and diastolic blood pressure \< 170 and \< 100 mmHg, respectively;
* Women not pregnant;
* Free and informed consent term signed the screening visit;
* Ability to adhere to the visits.

Exclusion Criteria:

* Failure to comply with any of the inclusion criteria;
* Treatment for DME within the prior 3 months;
* Vitreoretinal traction within 1 disc diameter (DD) of the fovea, clinically confirmed or with OCT;
* Atrophy or fibrosis surrounding the fovea;
* Any level of cataract;
* Vitreous hemorrhage or any opacity means;
* Eye disease related to diabetic retinopathy that can derail the central vision (eg Age Macula Degeneration, chorioretinitis scar, ...)
* Best-corrected visual acuity to 20/40 (\> 68 letters ETDRS)
* Inability to understand the treatment and the term of consent;
* Debilitating systemic disorders that preclude the patient's admission to the study, according to the clinical judgment of the investigator;
Evaluation of a Smartphone Application to Reduce Adverse Pregnancy Outcomes in Ethiopia

The purpose of this trial is to determine if the safe delivery smartphone application distributed to health workers in Ethiopia will decrease perinatal mortality and the incidence of postpartum haemorrhage. It is also the purpose to determine if the safe delivery smartphone application distributed to health workers in Ethiopia will increase health workers knowledge and skills in intra-partum management of active management of third stage labour 2) treatment of post-partum haemorrhage 3) manual removal of placenta and 4) neonatal resuscitation.

Abstract Hypothesis A safe delivery smartphone application distributed to health workers in Ethiopia will decrease perinatal mortality and the incidence of postpartum haemorrhage

A safe delivery smartphone application distributed to health workers in Ethiopia will increase health workers knowledge and skills in intra-partum management of active management of third stage labour 2) treatment of post-partum haemorrhage 3) manual removal of placenta and 4) neonatal resuscitation

Intervention A safe delivery smartphone application with animated videos to improve clinical management during delivery will be introduced in the intervention clusters

Design Cluster randomized controlled trial with health facilities as the unit of randomization

Area Nole Kaba, Haru, Homa, Genji and Gimbie districts in Ethiopia

Population Pregnant women and their newborns delivered in a randomized health facility. For secondary outcomes health workers at randomized health facilities.

Sample size 77 health facilities with minimum 2 health workers per facility and 30 deliveries per health worker

Duration Pregnant women will be enrolled at delivery and followed to 7 days postpartum

Outcomes Primary outcomes are perinatal mortality and postpartum haemorrhage. Secondary outcomes are health workers knowledge and skills

Study time Data collection expected from September 2013 to September 2014

Eligibility Criteria:
Inclusion Criteria:

• Women in active labor

Exclusion Criteria:

• None
Changes of Cerebral Glucose Metabolism After 12 Weeks of Paroxetine Treatment in Panic Disorder

Panic disorder is one of the most prevalent and disabling psychiatric disorders. Brain regions such as amygdala, hippocampus, periaqueductal gray (PAG), locus coeruleus, parahippocampal gyrus, frontal cortex, and thalamus has been reported to be related with the pathophysiology and treatment outcome in panic disorder. Paroxetine has been used as primary agent for treatment of panic disorder but there is little information on how paroxetine affects the brain function in patients with panic disorder.

The specific aim of this study is to examine the differences in brain activity between responders and nonresponders and to determine the predictor of paroxetine treatment in patients with panic disorder in terms of brain activity.


Eligibility Criteria:
Inclusion Criteria:

* panic disorder 20-60 years

Exclusion Criteria:

* history of major psychosis (schizophrenia or bipolar disorder), social phobia, obsessive-compulsive disorder, and generalized anxiety disorder, and posttraumatic stress disorder, alcohol abuse and dependence, current regular use of benzodiazepines
* less than 17 on the HAM-D
Preliminary Study of Uterine Healing After Caesarean Section: CLInico-ECHOgraphic and Anatomopathologic COrrelation

Caesarean section is one of the most common surgical procedures. The multiplication of uterine scars leads to an increase in complications and in particular those related to poor healing such as isthmocele or uterine rupture.

The processes of uterine healing at the histological scale are little known. The main objective of the research is to analyze the process of uterine healing by means of uterine biopsies performed on the areas of cesarean section scars.

Our hypothesis is that there is a histological healing defect visible on an anatomopathologic examination of the scar. This poor uterine healing on histological scale is probably associated with uterine healing defects visible on pelvic ultrasound (scar dehiscence) and clinical criteria (number of caesareans, symptoms).

The objective of the research is to analyze uterine scarring by means of uterine biopsies performed on the areas of cesarean section scars. The uterine scarred areas will be analyzed histologically according to specific criteria and compared to healthy uterine areas. Histological characteristics will be compared with clinical and ultrasound data.

Eligibility Criteria:
Inclusion Criteria:

* Common to all groups:
* Adult patient,
* Signed consent for participation in the study
* Patient affiliated to a social security scheme (excluding AME)

Group 1:

* Support for a scheduled or emergency caesarean (excluding patients having an emergency caesarean (red code: caesarean within 15 minutes))
* Scarred uterus: having already benefited from a caesarean section

Group 2:

- Surgical management of caesarean section scar dehiscence after a caesarean section

Group 3 (control):

* Support for a scheduled or emergency caesarean (excluding patients having an emergency caesarean (red code: caesarean within 15 minutes)
* Healthy uterus: no history of caesarean section (history of vaginal delivery or first pregnancy)

Exclusion Criteria:

* Disorder of hemostasis at risk of bleeding
* Anatomopathological sampling not feasible
* Patient with a history of upper genital infections
* Patient under legal protection (guardianship, curatorship)
* Patient who does not speak or understand French
* Patient unable to answer questions or with difficulty in expressing herself
Psychodynamic Psychotherapy for Psychosis

The broad goals of our pilot study are to (1) determine whether psychodynamic psychotherapy for psychosis (PPfP), relative to treatment as usual (TaU), can maintain or augment clinical and functional benefits for patients who have achieved initial recovery in our coordinated specialty care (CSC) early psychosis treatment program; (2) to conduct novel empirical study of how various psychodynamic factors may inform candidate selection, mediate therapeutic effects, and influence relational aspects of the therapy; and (3) to conduct a detailed study of how features of therapist and patient speech and behavior influence therapeutic outcomes, therapeutic alliance alliance, and relational process. This registration focuses on the first goal.


Eligibility Criteria:
Inclusion Criteria:

* completed the 2-3 year Coordinated Specialty Care (CSC) program
* judged by present provider to be in an intermediate or advanced phase of recovery
* had first episode of psychosis within the 3 years prior to enrollment

Exclusion Criteria:

* established diagnosis of primary affective disorder, psychosis secondary to substance use or a medical illness
* inability to communicate in English
* eligibility for Department of Developmental Services
* legally mandated to enter treatment.
Study of Anitocabtagene-autoleucel in Participants With Relapsed Refractory Multiple Myeloma

Master protocol for cell therapy, Phase 1 proof-of-concept studies in relapsed and refractory multiple myeloma and includes long-term safety follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Relapsed and refractory Multiple Myeloma treated with at least 3 prior regimens of system therapy including Proteosome Inhibitor (PI), immunomodulatory drugs (IMiD), and anti-CD38 antibody (CD38mab); or has "triple-refractory" disease
* Documented measurable disease
* Adequate organ function
* Life expectancy \> 12 weeks, Eastern Cooperative Group Performance Status 0-1

Exclusion Criteria:

* Plasma Cell Leukemia or History of Plasma Cell Leukemia
* Patients with a history of severe hypersensitivity to DMSO should be excluded
* Contraindication to fludarabine or cyclophosphamide
* Severe uncontrolled intercurrent illness (e.g., infection) or laboratory abnormalities
* Active central nervous system disease involvement by malignancy or active CNS pathology
Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve Sustained Virologic Response (SVR) in Genotype 2, 3 Chronic Hepatitis C Patients?

Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3. Studies rarely address the issues of improving host factors. The current study examines

1. Does 3 months therapy with Vitamin D+ Peg + Ribavirin could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks)
2. whether Vitamin D levels predicts negative treatment outcome.

Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2, 3. Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D, a potent immunomodulator, for 3 months therapy could improve viral response. The working hypothesis is that 3 months therapy with Vitamin D + Peg + Ribavirin significantly improves RVR, EVR, and SVR.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age
* chronic genotype 2,3 HCV infection
* treatment Naive negative sero for HBV, HDV and HIV viral infections
* absolute neutrophil count of \>1500 per cubic millimeter
* a platelet count of \>90,000 per cubic millimeter normal hemoglobin level

Exclusion Criteria:

* decompensated liver disease (cirrhosis with CP score \>9)
* another cause of clinically significant liver disease hepato cellular carcinoma
* psychiatric Disorder
* chronic heart failure
* pregnant women
* uncontrolled diabetes with retinopathy Arrhythmia Active CAD
* positive sero for HBV, HDV and HIV viral infections or other autoimmune liver disease
TiO2-scaffolds for Alveolar Ridge Preservation

The goal of this clinical trial is to evaluate the safety of placing TiO2 scaffolds in alveolar ridge and to evaluate if the scaffold material contributes to maintain the anatomy and the volume of the alveolar process after tooth extraction.

The primary objective of the clinical trial is to evaluate the safety of placing TiO2 scaffolds in alveolar ridge.

The secondary objectives are; (1) to assess anatomical changes as measured by intraoral digital scanning at the time of extraction, after 6 months. (2) to evaluate soft tissue inflammation at 1, 2, 4, 12 and 24 weeks post-surgery, (3) to assess the preservation of the alveolar ridge following placement of TiO2 scaffold in the alveolae after tooth extraction, (4) to assess bone mineralization and quantitative healing in bone biopsies obtained at implant installation in the preserved site 6 months following treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be ≥ 20 years, and present with a molar or premolar planned for extraction

Exclusion Criteria:

* Individuals with medical conditions that may affect soft tissue or bone metabolism
* Previous local radiotherapy
* Current use of chemotherapy
* Systemic long-term corticosteroid treatment.
* Diabetes
* Smokers (\> 10 cigarettes/day).
* Patients with active of untreated periodontal disease.
* Present or past use of bisphosphonate treatment
* Pregnant or nursing subjects
* \> class 2 according to the ASA (American Society of Anesthesiologists) physical status classification
* Acute infection or no apical periodontitis visible on radiograph of tooth planned for extraction.
Rivaroxaban in Left Ventricular Thrombus

The left ventricular (LV) thrombus is an important complication of myocardial infarction (MI) and vitamin K antagonist (VKA) is the current recommended management therapy for these patients. However, lack of regular international normalized ratio (INR) monitoring, drug, and food interaction may leads to increased risk of over or under anticoagulation consequently compromising the effectiveness of the therapy. Hence, due to benefits like predictable dosing and lack of need for regular monitoring, use of non-vitamin K antagonist oral anticoagulants (NOACs) for these patients is increasing among cardiologists. However, clinical data for the justified use of NOACs in LV thrombus (LVT) are lacking and remained a point of debate among the cardiologists. A recently published Randomized Control Trial (RCT) by Abdelnabi M et al. namely the No-LVT trial, had established the safety of Rivaroxaban therapy in patient with post myocardial infarction (MI) LV thrombus along with promising efficacy. However, sample size of the study (n=79; 39 in Rivaroxaban and 40 Warfarin) was not sufficiently high enough to conclude efficacy of Rivaroxaban in these patients. Therefore, this open label RCT is designed with the primary objective to evaluate the efficacy of Rivaroxaban in resolution of post MI LV thrombus as compared to standard warfarin therapy at the interval of 1 month and 3 months to test the hypothesis that Rivaroxaban is safe and non-inferior in preventing thromboembolic and major bleeding events in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients of acute coronary syndrome with LV thrombus
* Hemodynamically stable
* Willing to participate

Exclusion Criteria:

* Prior history of cardiomyopathy
* Anticoagulant contraindications
* Prior history of stroke with residual neurological deficit
* Valvular atrial fibrilation
* Pregnancy
* Mentally retarded
* Deranged liver function tests (LFTS)
* Creatinine Clearance \<50 ml
A Study to Assess Molecular Changes in Adult Participants With Moderate to Severe Hidradenitis Suppurativa or With Moderate to Severe Atopic Dermatitis Receiving Subcutaneous Injections of Lutikizumab

Hidradenitis suppurativa (HS) and atopic dermatitis (AD) are chronic inflammatory skin diseases that lead to the development of skin lesions and symptoms such as pain and discomfort. The purpose of this study is to assess molecular changes in adult participants with moderate to severe HS or with moderate to severe AD.

Lutikizumab (ABT-981) is an investigational drug being developed for the treatment of HS and AD. This study will consist of 2 sub-studies: Sub-Study 1 moderate to severe hidradenitis suppurativa and Sub-Study 2 moderate to severe atopic dermatitis. Approximate 60 participants will be enrolled in the study at approximately 2 sites in the US.

In Sub-Study 1 HS participants will receive subcutaneous (SC) injections of lutikizumab for up to week 15 with a 70-day follow-up period. In Sub-Study 2 AD, participants will receive subcutaneous (SC) injections of lutikizumab for up to week 14 with a 70-day follow-up period. The study duration for Sub-Studies 1 and 2 is expected to last up to 30 weeks.

Participants in Sub-Study 1 (HS) who complete Week 16 and showed a therapeutic benefit to lutikizumab, as confirmed by the investigator, will have the option to enter an open-label long-term extension (LTE) to continue to receive lutikizumab for up to an additional 140 weeks, followed by a 70-day follow-up period.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and biomarker collections.


Eligibility Criteria:
Inclusion Criteria:

* Sub-Study 1 hidradenitis suppurativa (HS):
* Participants with a diagnosis of moderate-to-severe HS for at least 6 months prior to Baseline as determined by the investigator
* Participants naïve to biologic treatment for HS or must have a prior inadequate response or loss of response to anti-TNF therapy for HS (\>= 12 weeks of therapy).
* Sub-Study 2 atopic dermatitis (AD):
* Participants with a diagnosis of moderate-to-severe AD with onset of symptoms at least 1 year prior to Baseline.
* Participants naïve to biologic treatment for AD or must have a prior inadequate response or loss of response to dupilumab for AD (defined as \>= 8 weeks of therapy with dupilumab).

Exclusion Criteria:

* History of any malignancy within the last 5 years except for successfully treated nonmelanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.
* History of active skin disease (other than HS for Sub-Study 1 or AD for Sub-Study 2) that could interfere with the assessment of HS (for Sub-Study 1) or AD (for Sub-Study 2), including skin infections (e.g., bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline.
E6/E7 mRNA Performance to Detect HSIL and Cost-effectiveness Analysis of This Screening Strategy in HIV + MSM

This study evaluates the positive and negative predictive value of E6/E7 mRNA expression for anal HSIL and its capacity to predict incident HSIL in HIV + MSM. We also analyse the cost-effectiveness of this new screening strategy. It is an ambispective study with 355 participants and a follow-up period of 2 to 5 years.

Introduction: Anal cancer incidence is increasing in HIV-infected men who have sex with men (MSM). There are still no standardized criteria for anal cancer screening. Anal cytology has not shown enough sensitivity and specificity in the selection of patients who need more invasive procedures, as high resolution anoscopy (HRA). Human Papillomavirus (HPV) E6 and E7 oncogenes deregulation is a crucial factor in neoplasic lesions progression.

Objectives: 1)To assess the negative and positive predictive value of E6/E7 mRNA expression for high-grade squamous intraepithelial lesions (HSIL) and its capacity to predict the incidence of new HSIL during the follow-up 2)To analyze the cost-effectiveness of E6/E7 as a new screening strategy for anal cancer compared with usual strategies (cytology and DNA detection).

Methodology: Ambispective longitudinal study. Participants: HIV MSM from the outpatients HIV and STD Unit of Bellvitge Hospital. We include patients visited within the usual outpatient practice since January 2015 with a cytology stored following the Hospital protocol, as well as patients collected prospectively since January 2017. This methodological approach will let to reduce the time of inclusion and maximize follow-up time. Sample size calculated: 355 participants. Follow-up period: 2 to 5 years. At each visit an anal smear for cytology, HPV DNA detection (by Linear Array and Hybrid Capture) and E6/E7 mRNA expression and a HRA with biopsy of suspicious areas of dysplasia will be performed. The analysis of cost-effectiveness will be made with a Markov model that projects long-term cost and effectiveness for both strategies, the E6/E7 and conventional cytology plus detection of High Risk HPV.

Eligibility Criteria:
Inclusion Criteria:

* Men who have sex with men \>= 18 years
* HIV documented infection
* Signature of the informed consent

Exclusion Criteria:

* Previous diagnosis of anal cancer.
* Treatment of anal intraepithelial lesions the 5 years before study inclusion.
* Suspect infiltrating anal cancer, requiring exploration under anesthesia and surgical removal for histological confirmation.
* History of diffuse ano-genital condylomatous disease the 5 years before study inclusion or presence at first visit.
* Other factors that could prevent correct diagnosis and monitoring of the anal dysplastic lesions (test intolerance, proctological pathology that does not allow HRA, etc.).
DAHANCA 28A: Phase I/II Study on Accelerated, Hyperfractionated Radiotherapy With Concomitant Cisplatin and Nimorazole

P16 negative cancers continue to have a dismal prognosis despite advances in the treatment of head and neck cancer. Acceleration, dose-escalation, hyperfractionation, chemotherapy and nimorazole has been shown to improve local control. The purpose of the study i to investigate the level of co-morbidity and performance status (PS) that allows the combination of all of the above means of treatment intensification


Eligibility Criteria:
Inclusion Criteria:

* Squamous Cell Carcinoma head and neck cancer of the pharynx, larynx and oral cavity
* P16 negative
* T1-4
* N1-3
* M0
* Organ function and performance status allowing radical chemo-radiotherapy

Exclusion Criteria:

* None
Probiotic VSL#3 for the Treatment of Gastrointestinal Symptoms Associated to Fibromyalgia

The study evaluated the efficacy and tolerability of probiotic VSL#3 for the treatment of gastrointestinal symptoms in patients with fibromyalgia; 50% of the participants received probiotic and the remaining 50% received matching placebo in a double-blind, randomized design.The treatment was administered during a 12-week period and the participants were followed for an additional 12-week period in order to follow the evolution after treatment.

Many patients with fibromyalgia experience associated gastrointestinal symptomatology such as abdominal pain, abdominal bloating, meteorism, diarrhea and/or constipation. To date there is not any specific treatment for these symptoms that markedly impair the quality of life of these subjects. This trial intended to investigate if the addition of a polymicrobial probiotic product, which has shown efficacy in patients with irritable bowel syndrome, was also be useful to ameliorate the gastrointestinal symptomatology of patients with fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed of fibromyalagia
* experiencing at least 3 chronic gastrointestinal symptoms
* signed informed consent to participate
* accept to not change previously prescribed treatment during study duration

Exclusion Criteria:

* mental illness excepting depression
* severe organic disease
* additional gastrointestinal disease excepting irritable bowel syndrome
* pregnancy
* breastfeeding