cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties

Primary objective:

- To assess the efficacy of eplivanserin 5mg/day in comparison to placebo after 6 weeks of treatment on sleep maintenance of insomniac patients, as measured by Polysomnography Wake Time After Sleep Onset (PSG-WASO) and Polysomnography Number of Awakenings (PSG-NAW).

Secondary objectives:

* To evaluate the effects of eplivanserin 5mg/day as compared to placebo after 6 weeks of treatment on other sleep parameters measured by PSG recordings (Total Sleep Time - PSG-TST, Sleep Efficiency - PSG-SE, Latency to Persistent Sleep - PSG-LPS) and reported by patients (Wake Time After Sleep Onset - pr-WASO, Number of Awakenings - pr-NAW, Total Sleep Time - pr-TST, Quality of Sleep - QoS and Refreshing Quality of Sleep - RqoS).
* To evaluate the effects of eplivanserin 5mg/day on sleep architecture compared to placebo.
* To evaluate the effect of eplivanserin 5mg/day on daytime functioning using the Sleep Impact Scale (SIS), as compared with placebo after 6 weeks of treatment.
* To evaluate patient's impression of treatment effects using the Patient's Global Impression questionnaire.
* To evaluate the potential for next-day residual effects (using patient's morning questionnaire and psychometric tests) with eplivanserin 5mg/day as compared to placebo.
* To evaluate the potential for rebound insomnia following abrupt discontinuation of eplivanserin 5mg/day in comparison with placebo.
* To evaluate the effect of eplivanserin, compared to placebo, on the quality of life of patients with primary insomnia using the SF-36 Health Survey.
* To evaluate the clinical safety and tolerability of eplivanserin 5mg/day compared to placebo.

Randomized, double-blind, placebo, controlled study with 2 parallel groups Duration of treatment : 6 weeks

Duration of observation: 9 weeks

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary insomnia based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revisions) criteria

Exclusion Criteria:

* Inpatients.
* Mean screening PSG-WASO for screening night 1+ screening night 2 \< 45 mn, or screening night with PSG-WASO \< 30 mn.
* Mean screening PSG-TST for screening night 1 + screening night 2 ≥7 hours or ≤3hours.
* Mean screening PSG-LPS for screening night 1+ screening night 2 \> 30 mn.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Frequency of Elevated Fecal Calprotectin Levels in Psoriatic Arthritis.

Background.Recent epidemiologic studies have shown an association between psoriasis, psoriatic arthritis (PsA) and inflammatory bowel diseases (IBD). Recently, measurement of fecal calprotectin (FC) demonstrated a good sensitivity and specificity for intestinal inflammation.

Primary objective of present study was to evaluate the presence of occult bowel inflammation in patients with PsA as expressed by elevated levels of FC. Secondary objectives were to investigate the correlation between the levels FC and clinical and laboratory features, and the outcome of CF-positive patients in terms of IBD development.

A number of studies evaluated the presence of occult intestinal inflammation by using FC assay in patients with axial SpA. In 2000, a study conducted in PsA patients without bowel symptoms showed at mucosa biopsies the presence of microscopic changes, increase in lamina propria cellularity, consisting of plasma cells and lymphocytes, and lymphoid aggregates.Present prospective case-control study was designed to investigate occult intestinal inflammation by using FC assay in consecutive patients with PsA at onset, and who had no abdominal symptoms. Five Italian Centers contributed to patients recruitment adopting the same inclusion and exclusion criteria over a 3 year period.

FC levels were measured at baseline with Bühlmann fCAL Turbo, Switzerland® kit. This automated method is a particle enhanced turbidimetric immunoassay employing polyclonal antibodies. The manufacturer cut-off for FC positivity was 50 μg/g, with a sensitivity of 100% and a specificity of 53.1%.

The number of patients developing IBD was evaluated at the end of follow-up. Clinical and laboratory data collection was centralized and two experts statisticians performed the data analysis.

Statistical analysis. All demographic, clinical, and laboratory data were collected and descriptive statistics, presented as mean value and standard deviation, were calculated using Microsoft ® Office Excel for Windows and ©2019 Minitabs, LLC for Windows. Chi-square test was used for categorical variables. FC test sensitivity, specificity, positive (PPV) and negative (NPV) predictive values were calculated. Bayes's theorem was used to calculate the 95% confidence interval (95%CI). Correlations were calculated using Spearman's correlation (rs). P values ≤ 0.05 were accepted as statistically significant.

The median follow-up was 30 months.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* absence of any abdominal symptoms or diarrhoea
* non-steroidal anti-inflammatory drug (NSAIDs) interruption 10 days before enrollment
* Corticosteroids (CS) at stable low dose (prednisone 10 mg/day or equivalent) during the preceding 2 weeks were permitted in both groups.

Exclusion Criteria:

* age \< 18 years
* previous diagnosis of CD or UC or current diagnosis of infectious colitis
* previous therapy with traditional DMARDs or any biologic therapies
* CS at high doses.
Levobupivacaine and Postoperative Pain Relief

The study analysed direct levobupivacaine instillation in surgical wound and its effectiveness in postoperative pain control. Half participants received 0,5 % levobupivacaine and the other half received 0,9% saline solution

Inguinal hernia is one of the most common conditions that requires elective surgical repair in children. The issue of post-operative pain in children is important, particularly because the surgical intervention per se is a stressful experience, after which the level of stressors in the recovery period should be minimized. Stress, including the pain in the postoperative period, could contribute to a delayed postoperative wound healing and recovery. Also, untreated acute pain could interfere with cognitive function, immune response as well as lead to the development of chronic postsurgical pain. For this reason, it is vital to reduce the painful sensations over the postoperative period as much as possible.

Levobupivacaine is a long-acting local anesthetic. Evidence from animal models and human volunteer participants showed that levobupivacaine has favourable effects on cardiovascular and central nervous systems. Clinical studies have also showed that levobupivacaine has a very low risk of systemic toxicity. A combination of levobupivacaine with non-opioid analgesics could have a beneficial role in the postoperative recovery from inguinal hernia surgery in terms of pain relief. The purpose of this study was to examine the effectiveness of levobupivacaine instillation combined with the routine postoperative non-opioid analgesia in children who underwent inguinal hernia repair.

It is very important for children to leave the hospital without additional support. Instilled levobupivacaine applied directly to the wound, currently interrupting transmission of the painful stimuli from the site of major trauma. The dose of applied levobupivacaine in this study is 2 times lower than that administered for caudal block and 4 times lower than the maximum dose. Analgesic effectiveness of this procedure is measured by the frequency of administration of a mixture of ibuprofen and acetaminophen over 24 hours after surgery, and duration of time between the administration of two doses.

Eligibility Criteria:
Inclusion Criteria:

* elective surgery
* not having incarcerated hernia
* not having previous surgeries requiring general anaesthesia American Society of Anesthesia scores I and II
* not having allergy to topical anesthetics, paracetamol, ibuprofen and/or general anesthetics, opioids or muscle relaxants

Exclusion Criteria:

* worsening of health status prior to surgery
* parental withdrawal to study
A Prospective Trial for the Effectiveness of the Use of Spinal Cord Stimulation (SCS) in Failed Knee Surgery

A study for patients who have chronic postoperative pain who had knee replacement surgery. If qualified, a 14 day trial and an implantation of spinal cord stimulator for control of pain will be administered. This study will evaluate effectiveness of pain control. Subjects will be followed for one year post implantation.

Male and Female over the age of 18 who have had a total knee replacement at least nine months ago. Continue with unilateral knee pain equal to or greater than 4 on a 1 to 10 scale. Subjects will receive a trial placement of spinal cord stimulator for 5 to 10 days. if trial is successful subjects will proceed to permanent placement of stimulator for the treatment of the knee pain. subjects will then be followed post implant to assess the effectiveness of the stimulator for the pain.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* total knee replacement at least nine months prior to enrollment
* unilateral knee pain at least 4 or more on a 1-10 visual analog scale
* failed other conservative treatments -

Exclusion Criteria:

* life expectancy of at least 6 months
* significant disease including Complex Regional Pain Syndrome,ipsilateral radiculopathy
* presence of pacemaker/vns or other Spinal Cord Stimulator
* previous lumbar surgery
* active infection
* unable to hold anticoagulants
Bilateral vs. Unilateral Stimulation in Neurological Bladder Disroders

This study evaluates the effectiveness of bilateral stimulation of the tibial nerve compared to unilateral stimulation in neurological bladder disorders.

Urinary disorders are common in neurological diseases. The prognosis of neurological bladders is twofold. On the one hand, symptoms such as incontinence or retention affect quality of life and comfort. On the other hand, complications such as urinary tract infections or renal failure threaten health and even involve patients' vital prognosis. Several therapies are used to treat these urinary disorders including transcutaneous or percutaneous posterior tibial nerve stimulation (SNTP). SNTP is used in treating symptoms of bladder overactivity. This treatment is most often used unilaterally, but can be used bilaterally.

The aim of this study is to evaluate the effectiveness of bilateral stimulation of the tibial nerve compared to unilateral stimulation in neurological bladder disorders.

50 patients will be included, in two arms by randomization, one arm of 25 patients will be treated by unilateral stimuylation and the other arm of 25 patients will be trated by bilateral stimulation.

They will be evaluate at 3, 6 and 12 months by auto questionnaire and the effectivess of each therapy will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who received research information
* Individuals affiliated to a social security scheme
* Individuals over 18 years of age
* Individuals with non-serious neurological bladder hyperactivity

Exclusion Criteria:

-
Nalbuphine and Flurbiprofen for Oculoplastic Surgery

The purpose of this study is to evaluate the postoperative pain and discomfort using flurbiprofen axetil or nalbuphine administration after oculoplastic surgery under general anesthesia.

In this randomized controlled clinical trial, we evaluated the postoperative analgesic efficacy and adverse effects of flurbiprofen axetil combined with nalbuphine in patients undergoing oculoplastic surgery compared with a single dose of flurbiprofen axetil or nalbuphine.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing oculoplastic surgery
* age between 16 and 75 years
* American Society of Anesthesiologists (ASA) physical status of I-II

Exclusion Criteria:

* serious coexisting disease
* body mass index (BMI) \<18.5 or \>35
* contraindications or previous adverse reactions to any of the drugs used
* females with a positive pregnancy test
* patients unable to cooperate
Hospitalized Children and Adolescent Patients With Type 1 Diabetes During the COVID-19 Pandemic in Egypt

Although reports showed that children with well controlled diabetes do not appear to have increased risk of infection with SARS-CoV-2, however data are scarce regarding the extent to which clinical and demographic data of patient could modify the outcome and severity of the disease. Additionally, the link between covid-19 and diabetes remains controversial.

Data from poorly controlled patients with type 1 diabetes remains controversial regarding whether diabetes itself could increases the susceptibility of infection with SARS-CoV-2 and subsequently impacts the outcomes in these patients , or the SARS-CoV-2 subsequently affects the risk of type 1 diabetes and increase in the prevalence of severe DKA.

Poorly controlled diabetes and chronic hyperglycemia creates a state of low grade chronic inflammation, which may explain the underlying mechanism of increased susceptibility to infection and infer the outcome in patients with diabetes .

Poorly controlled diabetes has been linked to multiple derangements of immune system including inhibition of lymphocyte proliferation in response to different stimuli, as well as impaired monocyte/macrophage function together with increased synthesis of pro-inflammatory cytokines and adhesion molecules that mediate tissue inflammation .

Few data links the association between development of diabetic ketoacidosis in patients with COVID-19, where the infection could trigger higher stressful conditions, with the release of stress hormones leading to increased blood glucose levels and abnormal glucose variability .

The extent to which clinical and demographic data of patients with type 1 diabetes modifies the outcome and severity of the disease seems entirely unclear and is the question of several researches.

• Study Tools:

All patients admitted to Pediatrics Hospital, Ain Shams University in the period between May to August 2020 will be subjected to:

1- Detailed history 2. Thorough clinical examination: To assess the inclusion and exclusion criteria. A thorough clinical review to assess organ involvements and clinical and laboratory characteristics as well as the outcome measures in the studied cohort.

3. Data collection: Demographic and data will be extracted from patients inpatient files and reports

Eligibility Criteria:
Inclusion Criteria:

* All patients with type 1 diabetes admitted to Pediatrics Hospital, Ain Shams University in the period between May to July 2020.
* Age: less than 18 years old.

Exclusion Criteria:

• Children with other forms of diabetes, including: type 2, monogenic forms and secondary diabetes
Comparison of the Computer Controlled and Conventional Local Anesthesia Techniques in Primary Molar Extraction in Children Aged 5 to 9 Years Old

The goal of this clinical trial is to assess pain perception, child stress level and compare the effectiveness between periodontal ligament anesthesia using Computer-controlled Local Anesthetic delivery system and the Conventional Inferior Alveolar Nerve Block during extraction of the primary molars.

The main questions it aims to answer are:

Is there a difference in pain perception, child stress level and anesthesia effectiveness between the CC-ILA system and the traditional syringe when administering IANB in pediatric patients undergoing primary molar extractions.

Researchers will compare CC-ILA system to traditional syringe when administering IANB to see if there a difference in pain perception, child stress level and anesthesia effectiveness.

Participants will:

Have their lower first primary molar extracted by receiving either periodontal ligament anesthesia using computer-controlled local anesthetic delivery system or the conventional inferior alveolar nerve bock.

Pain perception during the anesthesia process was measured using both objective criteria through the Sound-Eye-Motor scale and subjective assessment using Wong-Baker Faces Pain Rating Scale. Salivary cortisol level will be used to determine child stress level. The efficacy of anesthesia at various stages of the extraction procedure was evaluated using the Sound-Eye-Motor scale.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children (ASA I).
* Ranging in age from 5-9.
* Cooperative (Frankle ++).
* With mandibular first primary molars earmarked for removal owing to factors such as: extensive caries, crown damage, periapical lesions and unsuccessful pulp treatment.

Exclusion Criteria:

* Mobile teeth (Grade III).
* Ankylosed teeth.
* Teeth with root resorption (more than 1\\3).
* Patients with facial cellulitis and when there is a need for supplemental anesthesia
Identification of Differences in Breath Components Detected With IMS in Patients Tested on SARS-CoV-2 (COVID-19)

Breath analysis is the evaluation of exhaled air of humans. It aims to get information about the clinical status of a human being by monitoring its volatile organic compounds (VOCs) in exhaled air.

In this feasibility study it is intended to find specific biomarker(s) in exhaled breath indicating an infection with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).


Eligibility Criteria:
Inclusion Criteria:

* SARS-CoV-2-Polymerase chain reaction (PCR) test result is available
* Signs or symptoms of any respiratory system infection or Signs or symptoms indicating SARS-CoV-2 infection or Radiological findings suggesting viral lung infection
* Breath test (Study intervention) must be performed within a 2 day time period after latest SARS-CoV-2 PCR

Exclusion Criteria:

* History of SARS-CoV-2 outside the current respiratory episode (known from medical history)
* Participation in another clinical study prior to breath analysis which could influence the result of the breath analysis
Gestational Diabetes: Induction Versus Expectant Management of Labour

The purpose of this study is to determine whether, in Gestational Diabetes Mellitus (GDM) pregnancies, induction of labour at 38-39 weeks of pregnancy is superior to expectant management in terms of maternal and neonatal outcomes.

Gestational Diabetes Mellitus (GDM) is one of the most common complications of pregnancy and its incidence is estimated as around 7%. Babies born from women with GDM are significantly more exposed to perinatal risk. Furthermore in GDM pregnancies an increased C-section rate has been observed, mostly unjustified.

Strong evidence, based on prospective studies and randomized controlled trials, in favour or against the effectiveness and safeness of induction in women with GDM, are missing. The aim of the present study is to identify the best management for these women at term and provide evidence that could change the current clinical practice.

To reach this objective, 1760 eligible women will be recruited at 9 Teaching Hospitals (5 in Italy, 4 all over the world). Sample size has been estimated to demonstrate a difference between the two arms ≥ 6% (31% of C-section in the expectant group and 25% in the induction group; relative difference between the 2 groups equal to 20% in favor of induction; Kjos et al, 1993), considering an α error equal to 5% and 80% power.

Patients will be randomized to induction of labour (N=880) or expectant management (N=880). Data on maternal and neonatal outcomes will be collected at delivery and until maternal and neonatal discharge.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age \> 18;
* Singleton pregnancy in vertex presentation;
* Gestational age between 38-39 weeks verified by LMP and first trimester ultrasound when available;
* Women diagnosed with GDM in the current pregnancy \[Diagnosis will be based upon abnormal 50 Gr. GCT (\>140) followed by \>2 abnormal indices in the OGTT (according to C\&C criteria). Women with GCT\>200 mg/dl will undergo 100 gr OGTT as well\];
* No other contraindications for vaginal delivery.

Exclusion Criteria:

* Pre-gestational diabetes;
* Prior C-section;
* Suspected estimated fetal weight\> 4000 gr. at enrollment;
* Any known contraindications for vaginal delivery;
* Uncertain gestational age;
* Non-reassuring fetal status necessitating immediate obstetrical intervention (prompt delivery/prompt C-section);
* Maternal disease complicating pregnancy and necessitating delivery (e.g Severe PET);
* Bishop score \>7 at enrollment;
* Major fetal malformation.
Randomized Controlled Trial of a Gender-transformative School-based Sexual Health Intervention

The goal of this randomized controlled trial (RCT) is to evaluate the effectiveness of a comprehensive gender-transformative intervention of sexual education (ENFOCATE -Focus-on) in adolescents, using a mixed experimental design. The intervention will be directed exclusively to students of the 10th and 11th grades who are enrolled in one of the education establishments that depend on the Municipality of Santiago. The randomization will be by grade, and the data will be collected at three moments (pre-intervention, post-intervention and a 3-month follow-up).

The investigators propose a mixed experimental design with a randomized controlled trial (RCT) that will evaluate the efficiency of an intervention and implementation of a comprehensive gender-transformative sexual education, along with qualitative studies to understand the implementation process. The results of the intervention will be evaluated after it finishes, and in a three-month follow-up. Each participant will be sent a link to the questionnaire (web-based survey). Follow-up contact will be done with WhatsApp or telephone calls.

The hypothesis is that the intervention designed and implemented in the experimental group: (1) will increase their sexuality knowledge level; (2) will increase their preventive sexual behavior (or intentions); (3) will favor a gender-positive attitude; and (4) will decrease internalizing and externalizing problems in mental health. The secondary objective is to examine the implementation intervention process, that is, identify the strengths and obstacles in the real context in which the study intervention is performed, to understand the determinants and strategies of the success of the implementation.

Eligibility Criteria:
Inclusion Criteria

* Schools with students of the 10th and 11th grades who are enrolled in one of the education establishments that depend on the Municipality of Santiago.
* Schools not being an education center oriented to adults or persons deprived of liberty (e.g. closed or semi-closed compounds of Gendarmería de Chile or the National Service for Minors)
* Schools with regularity in teaching and learning (for example, schools that were not partially interrupted in 2022 by student manifestations)
* Schools with informed consent of the director.
* Students having 90% or greater attendance in classes
* Students providing informed consent of voluntary participation
* Students having explicit and informed consent of their parents or guardians.

Exclusion Criteria:

* Schools being an education center oriented to adults or persons deprived of liberty
* Schools without informed consent of the director
* Students without class attendance
* Students without informed consent of voluntary participation
* Students without an explicit and informed consent of their parents or guardians