cyrilzakka/clinical-trials huggingface dataset:
Software Treatment for Actively Reducing Severity of ADHD - Follow Up

This is an exploratory study to assess potential maintenance of clinical benefit (cognition and symptoms) following 4 weeks of at-home digital therapy in ADHD children.

The study will be a blinded (investigators and outcome assessors), randomized (from parent study Akili-001R), parallel group, follow-up study of the sustained effects of 4-weeks of treatment with either AKL-T01 (EVO Multi) game-based digital therapy or AKL-T09 (EVO Words) game-based digital therapy.

The trial will consist of 4 visits: Screening (to be conducted at the same time as the end-of-study visit for the parent study Akili-001R), FU-Day 28 visit (conducted in clinic), and FU-Day 56 and FU-Day 84 visits (conducted remotely via electronically captured parent reported outcomes).

Eligibility Criteria:
Inclusion Criteria:

* Completed Akili Study Akili-001R including all clinical assessments at DAY28 per the study protocol
* Ability to comply with all the testing and requirements per this protocol

Exclusion Criteria:

* Participant is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation or self-injurious behavior as measured by C-SSRS at screening
* Participant has demonstrated clinically significant deterioration in functioning as assessed by PI and other study staff that would contraindicate continued participation in the follow-up study
Pharmacokinetics and Safety of Posaconazole Tablet in Participants at High Risk for Invasive Fungal Infections (MK-5592-065/P05615)

The purpose of this study is to collect pharmacokinetic (PK) information related to how well posaconazole tablet is distributed in the body and to determine the safety of this new formulation. The study consists of a Phase 1B study that includes participants with neutropenia undergoing chemotherapy for acute myelogenous leukemia (AML) or myelodysplasia (MDS) and a Phase 3 study that includes participants who are undergoing chemotherapy for AML or MDS and participants who are recipients of allogeneic hematopoietic stem cell transplant (HSCT).

Participants with a blood disease or cancer that can affect their infection-fighting white blood cells and those who have undergone a hematopoietic stem cell transplant (HSCT) and are receiving immunosuppressive therapy and have or are at risk of graft-vs-host disease (GVHD) are eligible for the study. These blood diseases and their treatments can weaken the immune system and may put individuals at high risk for a serious fungal infection of their internal organs or blood (invasive fungal infection). As these infections can be hard to detect early and can be life-threatening, many physicians believe that individuals diagnosed with these diseases should receive antifungal therapy to try to lower their risk of getting this type of infection.

Enrollment into this study will take place in several stages (parts). The determination of which part a participant will be in is based on which part is open at the site at the time of enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Body weight \>34 kg (75 lb) and of any race/ethnicity
* Able to swallow oral tablets whole
* Anticipated (likely to develop within 3-5 days) or documented neutropenia due to chemotherapy, chemotherapy for a new diagnosis of acute myelogenous leukemia (AML), or AML in first relapse; myelodysplastic syndromes (MDS) in transformation to AML; allogeneic hematopoietic stem cell transplant (HSCT) participants in the pre-engraftment period or in the post-engraftment period if they are receiving immunosuppressive therapy for graft versus host disease

Exclusion Criteria:

- Female must not be pregnant, must not intend to become pregnant

during the study, and must not be nursing

* History of hypersensitivity to azoles
* Moderate or severe liver dysfunction defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than three times the upper limit of normal (ULN), AND a total bilirubin level greater than two times the ULN
* Electrocardiogram (ECG) with corrected QTc interval greater than 500 msec
* Posaconazole within 10 days before study enrollment
* Receipt of systemic antifungal therapy within 30 days of study enrollment for reasons other than antifungal prophylaxis
* Evidence of known or suspected invasive or systemic fungal infection at baseline
* Known or suspected history of Gilbert's disease
* Creatinine clearance levels below 30 mL/min
Therapeutic Anticoagulation Strategy for Acute Chest Syndrome

Acute Chest Syndrome (ACS) is a pulmonary complication of sickle cell disease (SCD) representing the leading cause of death and the second cause of hospitalization among adult patients. Pulmonary vaso-occlusion is one of the main pathophysiologic hypotheses during ACS. Our hypothesis is that therapeutic anticoagulation may reduce the severity of ACS via the alleviation of pulmonary thrombosis. The main objective of this prospective, randomized, double-blind study is to test the efficacy and safety of a curative anticoagulation strategy during ACS. The main efficacy endpoint is time to ACS resolution. The main safety endpoint is number of major bleedings.

A thoracic CT scan will be performed to check for pulmonary artery thrombosis. If the CT scan is positive (thrombosis within a large elastic artery), the patient will not be randomized and will be treated with a curative anticoagulation. If the CT scan is negative, the patient will be randomized to receive subcutaneous anticoagulation with low molecular weight heparin (tinzaparin) either at a curative dose (175 Unit International (UI)/kg/day for 7 days) or at a prophylactic dose (4500 UI/day).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Major sickle cell syndrome (SS, SC, Sβ)
* ACS defined by the association of a new infiltrate on chest X-ray or CT scan and a respiratory symptom or abnormal chest auscultation
* Written, informed consent

Main Exclusion Criteria:

* Pregnancy, post-partum
* Iodine allergy
* Extreme weight (\<40 kg or \> 100 kg)
* Moderate to severe renal insufficiency
* Moya-moya disease
* Symptomatic cerebral aneurysm
* Major transfusional risk
* Uncontrolled severe retinopathy
* All other contra-indications to curative anti-coagulation by tinzaparin.
Effects of a Health Intervention on Fear of Hypoglycemia : a Pilot Study

The purpose of this study was to construct a Fear of Hypoglycemia(FoH) intervention program for type 2 diabetic patients based on the Behaviour Change Wheel (BCW) theory and to investigate the feasibility, acceptability, and initial effects of the program.

In this study, eligible participants were randomized in a 1:1 ratio into an intervention group (health education based on BCW theory given on top of regular diabetes health education) and a control group (regular diabetes health education), with a 4-week intervention period and a 4-week follow-up period, for a total of 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Comply with the 2020 Chinese guidelines for the prevention and treatment of type 2 diabetes mellitus
* Age ≥18 years
* Duration of diabetes mellitus ≥1 year
* FOH according to the elevated item endorsement criterion (E I criterion): ≥3 points on any item of the Hypoglycemic Fear-Worry Scale (HFS-WS)
* Patients who have the ability to listen, read, write, walk, and cooperate to complete the study
* Patients who have a smart phone, and can skillfully use WeChat or telephone to communicate
* Voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria:

* Patients with comorbid acute complications or other serious diseases or disorders of consciousness, such as diabetic hypertonic state, tumors, coma, etc.
* Patients with comorbid psychiatric diseases or taking psychotropic drugs
* Patients who have recently or are participating in other studies on similar topics
A Eye Movement Desensitization Reprocessing (EMDR) Study in Bipolar Traumatized Patients

The purpose of this pilot study is whether Eye Movement Desensitization Reprocessing (EMDR), an approved psychotherapy in posttraumatic stress disorder, improves mood, functioning, quality of life, cognition and BDNF levels in subsyndromal bipolar patients with trauma.


Eligibility Criteria:
Inclusion Criteria:

* Bipolar I or II disorder following DSM-IV criteria
* Instable, subsyndromal course defined as at evaluation baseline (HAMD \> 8 \< 15 and/or YMRS \> 7 \< 14)
* Good adherence to pharmacological treatment
* Major or minor traumatic life-events
* EMDR therapists \> 3 years experience
* Able to sign informed consent

Exclusion Criteria:

* Major affective episode in last 3 months
* Active drug abuse/dependency
* Neurological disease
* Suicidal thoughts/ideation
* Prior treatment EMDR
* DES \> 25
Online Survey of Clinicians to Learn About Their Interpretation of Capnography Waveforms

This online survey presents capnography waveforms and asks the survey participants to give feedback about their interpretation of the patient status, both in the form of a score and a set of text to describe their interpretation.

The capnography waveforms presented were originally collected from patients in various clinical settings, with patients both intubated and non-intubated. The de-identified waveforms are presented along with a statement about whether the patients were intubated or not, the amount of supplemental oxygen provided, and in some cases, the oxygen saturation of hemoglobin in the blood (SpO2). The participants are asked to provide a score between 1 and 10 to indicate their interpretation of the wellbeing of the patient. The participants are also asked to provide up to two sentences of text to describe their interpretation of the patient condition based on the information provided.

Eligibility Criteria:
Inclusion Criteria:

* Clinicians who have at least two years of experience in interpreting capnography waveforms in their clinical practice

Exclusion Criteria:

-
Evaluation of Safety and Efficacy of Anticoagulation Treatment in Patients With Splanchnic Vein Thrombosis: SAPIENT Study

Prospective single-centre, observational study with medical products. Patients with a medical history of SVT will be observed for at least 24 months after inclusion. The study will begin when the patient is referred to our centre for SVT and will end at the 24-month follow-up or at the occurrence of a study outcome event, or in case of Death OBJECTIVE: To prospectively define the incidence of recurrent thrombosis and bleeding events during anticoagulant therapy in patients with diagnosed SVT, regardless of whether they will be hospitalized or treated as outpatients


Eligibility Criteria:
Inclusion Criteria

* age ≥ 18 years
* ability to provide informed consent;
* confirmed diagnosis of deep vein thrombosis involving splanchnic veins in liver cirrhosis (with or without hepatocarcinoma);
* confirmed diagnosis of deep vein thrombosis involving splanchnic veins in absence of liver cirrhosis (with or without portal cavernoma);
* pregnant patients will be eligible for inclusion in the study;
* ongoing anticoagulant treatment with vitamin K-antagonists (VKA), direct oral anticoagulants (DOAC), low molecular weight heparin (LMWH), fondaparinux

EXCLUSION CRITERIA

* splanchnic vein tumor thrombosis;
* absence of antithrombotic prophylaxis
Tetracycline Versus Doxycycline for HP Rescue Therapy

This randomized controlled clinical trial will evaluate the efficacy and safety of proton pump inhibitor, bismuth, metronidazole, and either tetracycline or doxycycline for Helicobacter pylori rescue treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori.


Eligibility Criteria:
Inclusion Criteria:

* Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
* 18-75 years old on the day of signing the ICF.
* Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
* Have failed eradication treatment before.

Exclusion Criteria:

* Have not received Hp eradication treatment.
* Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
* Subjects or guardians refused to participate in the trial.
* Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
* Have taken antibiotics, bismuth, PPI or Chinese traditional medicine 4 weeks before treatment.
* Pregnant or lactating women.
* Active peptic ulcer.
* allergic to drugs used in the trial.
* any other circumstances that are not suitable for recruitment.
A Study to Evaluate a New Silicone Hydrogel Contact Lens

The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* Be myopic and require lens correction from -0.50 D to -5.50 D in each eye.

Exclusion Criteria:

* Any systemic disease affecting ocular health.
* Using any systemic or topical medications that will affect ocular physiology or lens performance.
* An active ocular disease, any corneal infiltrative response or are using any ocular medications.
* Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Allergic to any component in the study care products.
Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Enhancin in Prevention of Postadenotonsillectomy Morbidity.

Null hypothesis; The efficacy of Enhancin\]Co-Amoxiclav given as a single intravenous dose at induction is not better than a five days oral course of the same given postoperatively in reducing postoperative morbidity after adenotonsillectomy.

Adenotonsillectomy results in morbidity that is reduced by the use of antibiotics.This study had the sole objective of comparing two route of administration to see which has superior results.

Eligibility Criteria:
Inclusion Criteria:

* Patients below 12year scheduled to undergo adenotonsillectomy whose parents or guardians give consent for recruitment into the study.

Exclusion Criteria:

* Non consenting parents or guardians. Antibiotic use in the week preceding surgery. Patients with co mordities. Known allergies to Co-amoxiclav. Patients who develop complication that warrant change of antibiotic.
Assessment of Pain and Antibacterial Activity of Chitosan Versus Sodium Hypochlorite as Irrigant in Infected Canal

A randomized clinical trial that aims to study the effect of chitosan nanoparticles (CS-np) versus sodium hypochlorite as a root canal irrigant on postoperative pain and antibacterial activity against E.faecalis in infected root canal.

This trial aims to study the effect of chitosan nanoparticles (CS-np) versus sodium hypochlorite as a root canal irrigant on postoperative pain and antibacterial activity against E.faecalis in infected root canal. initial pre-treatment root canal sample will be taken.These will be designated as sample no.1. after first sample, according to random sequence, the patients will be randomly assigned into two groups. In Group I: Sodium hypochlorite (NaOCL 2.5%) will be used during instrumentation of the canals.In Group II: chitosan nanoparticles (CS-np) will be used. after preparation, the sample no.2 will be taken.Pain will be assessed by giving the patient the numerical pain rating scale (NRS) to assess his pain at 24, 48 and 72 hours after the first visit.

Eligibility Criteria:
Inclusion Criteria:

* Young adult Patients, both genders, aging from 18-45 years.
* Patients with permanent mature teeth (closed apex).
* Single rooted single canal necrotic anterior teeth without apical periodontitis or with slight widening of peridontium.
* Patients should be free from any systemic disease.
* Patients with normal periodontal depth less or equal 3 mm.
* Patients who will agree to the consent and will commit to follow-up.

Exclusion Criteria:

* Patients with permanent immature teeth.
* Teeth with vital pulps.
* Patients with facial swelling or acute infection or pain on percussion
* Patients with fistula.
* Teeth with vertical root fractures, internal or external root resorption and calcification
* Teeth with periodontal involvement or periapical bone loss.
* Patients with any systemic disease that may affect predictable outcome.
* Pregnant or lactating females.
* Non-restorable teeth.
Spinal Analgesia for Colonic Resection Using an Enhanced Recovery After Surgery (ERAS) Program

This is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. The aim of this study is to assess whether spinal analgesia with a mixture of bupivacaine and morphine provides better pain relief than systemic morphine in a group of patients undergoing colonic resection and using the Enhanced Recovery After Surgery (ERAS) program.

Twenty patients will receive spinal analgesia and twenty patients will receive only Patient Control Analgesia (PCA).

This is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. The aim of this study is to assess whether spinal analgesia with a mixture of bupivacaine and morphine provides better pain relief than systemic morphine in a group of patients undergoing colonic resection and using the ERAS program.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to undergo laparoscopic colonic resection

Exclusion Criteria:

* patients who have trouble to understand, read or communicate either in French or in English
* dementia
* patients suffering from severe physical disability (arthritis, neuromuscular dysfunction, stroke, paraplegia) or inability to walk or conduct daily activity
* patients suffering from severe cardiac or respiratory disease (status ASA IV)
* patients suffering from metastatic carcinoma
* patients who have a history of chemoradiation within the six months preceding surgery
* morbid obesity
* contraindication to spinal analgesia
A Phase 2 Pilot Study to Assess ASP7147 in Patients With Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)

This trial will evaluate the effect of ASP7147 on daily abdominal pain due to IBS-D during 4 weeks of treatment. It will also evaluate safety and tolerability in patients with IBS-D over the 4-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent
* Men or women aged 18-75 years
* Patient has IBS with diarrhea (IBS-D)
* Ability to communicate with the investigator

Exclusion Criteria:

* IBS with constipation (IBS-C) or mixed IBS (IBS-M)
* Other significant disease or condition that may interfere with trial completion
* Untreated lactose intolerance
* History of alcohol or drug abuse in past two years
* Participation in other clinical trials within prior month
Detection and Characterization of COPD in Dairy Farmers

A pilot study from the investigators group suggests that the prevalence of chronic obstructive pulmonary disease (COPD) among dairy farmers is higher than in the general population. Most characteristics of COPD in dairy farmers (smoking habits, dyspnoea, quality of life, lung function, bronchial exhaled nitric oxide, systemic inflammation, arterial stiffness and exercise capacity) are largely unknown. Although immunization against organic dusts is suspected, the pathophysiology of COPD in dairy farmers is also unknown.

This study therefore aims at (i) comparing the prevalence of COPD in dairy farmers and in subjects without any occupational exposure (control arm) through a vast COPD detection program in the Franche-Comté region; (ii) comparing several characteristics (smoking habits, dyspnoea, quality of life, lung function, bronchial exhaled nitric oxide, systemic inflammation, arterial stiffness and exercise capacity) between dairy farmers with COPD and patients with COPD without any occupational exposure; (iv) identifying etiological factors of COPD in dairy farmers (comparison of exposure and specific immunoglobulin E between dairy farmers with COPD and dairy farmers with normal pulmonary function tests); and (v) constituting a cohort of COPD patients and control subjects for further longitudinal studies.

Data from selected patients (either current or former smokers) with mild COPD and from matched controls will also be analyzed in an ancillary study which objectives are to compare exercise tolerance, ventilatory constraints on tidal volume expansion and dyspnoea between asymptomatic mild COPD subjects, symptomatic mild COPD and healthy controls.

2000 dairy workers and 2000 subjects without any occupational exposure, all aged 40 to 74 years, will take part to a COPD screening program (spirometry and bronchodilation test) between September 2011 and October 2014.

Subjects with COPD and healthy matched controls will attend a second visit. If needed, COPD subjects will be asked to stop any respiratory related medication such as short and long acting bronchodilators 72 hours prior to the visit. All subjects will complete several questionnaires (quality of life, respiratory symptoms, smoking habits,...). A complete medical history will be collected, and a blood sample will be taken. Subjects thereafter will complete arterial stiffness measurement, exhaled nitric oxide and pulmonary function testing pre- and 30-min post-bronchodilator. A symptom-limited incremental cycle exercise test will be performed on the same day, at least 6 hours after the bronchodilator test and at least 4 hours after the meal.

Exposure to organic dusts will be quantified through analyze of electrostatic wipes left at subjects' homes for 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* subject aged 40-74 years
* either dairy farmer or unexposed to any occupational risk factor for COPD

Exclusion Criteria:

* COPD in GOLD stage 4
* pregnancy
* treatment with systemic corticosteroids
* established diagnosis of asthma
* established diagnosis of bronchiectasis
* established diagnosis of allergic alveolitis