cyrilzakka/clinical-trials huggingface dataset:
China Lung Cancer Screening (CLUS) Study Version 3.0

CLUS version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). CLUS version 2.0 evaluated the efficacy of new techniques (AI, AFI and MTB) in fostering the implementation of lung cancer screening (NCT03975504). The present multi-center study is performed to evaluate the effectiveness of different lung cancer screening strategy and validate our previous findings. 100,000 high-risk subjects (age 45-75) were recruited to take LDCT screening (Baseline + 2 biennial repeated LDCT screening). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored in a Biobank. Management of positive screening test was carried out by a pre-specified protocol.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants were those aged 45-75 years, and with either of the following risk factors:

  1. history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years;
  2. malignant tumors history in immediate family members;
  3. personal cancer history;
  4. professional exposure to carcinogens;
  5. long term exposure to second-hand smoke;
  6. long term exposure to cooking oil fumes.

Exclusion Criteria:

* Had a CT scan of chest within last 12 months
* History of any cancer within 5 years
Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn

Ocular chemical burn is one of the causes of vision loss in China, and there are no satisfactory treatment. Human umbilical cord mesenchymal stem cells(UC-MSCs) have the biological characteristics of self-renewal, immune regulation, multidirectional differentiation and tissue repair. Our preliminary research showed that in corneal alkali injury rabbits, the UC-MSCs can accelerated the cornea repair, inhibited angiogenesis. The aim of this study is to access the efficacy and safety of UC-MSCs in the treatment of corneal burn in human.


Eligibility Criteria:
Inclusion Criteria:

* must be ocular burns including chemically burned or the thermally burned;
* the subjects are willing to accept this research, and promise to coordinate with the researchers during the follow up period;
* the subjects should abide by the laws and rules of the study.

Exclusion Criteria:

* the visual acuity is blind in any of the eye;
* have corneal perforation or have the corneal perforation tendency;
* have been accepted surgery on eyeball after trauma;
* IOP\>=25 mmHg even after antiglaucoma;
* have the history of other corneal disease or surgery;
* have the history of radiotherapy or surgery in the eyeball;
* associated with corneal ulcer or endoophthalmitis;
* uncontrolled hypertension(\>=150/95 mmHg);
* abnormal liver and renal function;
* the pregnant women.
Impact of Covid-19 Pandemic on Patients Receiving Continuation or Maintenance Electroconvulsive Therapy

Electroconvulsive therapy is a safe and effective therapeutic strategy in patients with treatment resistant depression. As relapse after successful ECT is significant even with adequate pharmacological strategies, continuation (up to 6 months after completion of index-ECT) or maintenance ECT (more than 6 months after index-ECT) is often necessary to maintain remission. During the current Covid-19 pandemic hospitals redirected resources and closed or significantly diminished ECT services. In this study we aim to assess the impact of discontinuing maintenance electroconvulsive therapy in patients diagnosed with unipolar depressive disorder.

During the height of the Covid-19 pandemic in Belgium all patients receiving continuation or maintenance electroconvulsive therapy (ECT) for major depressive disorder in two ECT centers in Belgium will be included. Due to differences in Covid-19 infection rates and hospital management decisions, one ECT-service temporarily halted all electroconvulsive treatments, where as the other ECT-service continued continuation and maintenance treatments. Depressive symptomatology and relapse rates will be assessed during the diminished accessibility of electroconvulsive treatment.

Eligibility Criteria:
Inclusion Criteria:

* Continuation or maintenance ECT, in treatment at two specified ECT-centers in Belgium
* Unipolar depressive disorder

Exclusion Criteria:

* Unable to provide informed consent
* Unable to comply with study requirements (telephone questionnaire)
High-Definition 3D Visualization System for Ophthalmic Surgery

To validate a high-definition (HD) three-dimensional (3D) visualization system in cataract surgery


Eligibility Criteria:
Inclusion Criteria:

* The patients are scheduled to cataract surgery on both eyes.

Exclusion Criteria:

* The patients who have other complicating ophthalmic diseases or previous history of ophthalmic surgeries were excluded
An Open-Label Study of N-Acetyl Cysteine in Children With Autism

The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC) in children with Autism.

N-Acetyl Cysteine (NAC) is a compound that increases the levels of Glutathione, the body's main antioxidant. Glutathione is a compound in the blood that is part of a natural defense system (the antioxidant system). Anti-oxidants protect the body from damage caused by internal toxins called free radicals. It is possible that children with Autism tend to have lower levels of glutathione, an important compound in our bodies that helps combat the effects of toxic free radicals. We hope that by studying the antioxidant system in more detail, we will increase our understanding of the reasons why people develop Autism so that we can design better ways to treat individuals with this condition. This study is meant to test the safety tolerability of N-Acetyl Cysteine and its effectiveness in the treatment of behavioral difficulties in children with autism. It will also examine the possible benefit of this agent in improving the core deficits in autism such as social deficits.

Eligibility Criteria:
Inclusion Criteria:

Subjects will be eligible for this study if they participated in the Double-blind, randomized, placebo controlled study of N-Acetyl Cysteine in Autism study at Stanford University and meet all of the following criteria:

1. Outpatients between 3.0 and 12.11 years of age inclusive
2. Males and females who are physically healthy
3. diagnosis of autism based on Diagnostic and Statistical Manual (DSM-IV-TR) criteria, the Autism Diagnostic Interview-Revised, and expert clinical evaluation
4. Clinical Global Impression Severity rating of 4
5. Care provider who can reliably bring subject to clinic visits, can provide trustworthy ratings, and interacts with subject on a regular basis
6. Ability of subject to swallow the compound
7. Stable concomitant medications for at least 2 weeks
8. No planned changes in psychosocial interventions during the open-label N-Acetyl Cysteine trial

Exclusion Criteria:

1. Diagnostic and Statistical Manual (DSM-IV-TR) diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder, not otherwise specified
2. Active medical problems: unstable seizures, significant physical illness (e.g., serious liver or renal pathology)
3. Pregnancy or sexually active females
4. Subjects taking antioxidant agents and glutathione prodrugs will be excluded from the study except if they have been off these compounds for at least 4 weeks
Living in a Precarious Situation With an Autistic Child: What Are the Issues at Stake for Support in Care

Study the specificities of families in a precarious situation with a child with autism spectrum disorders (ASD) in terms of housing, in order to better support them in the various social spaces and improve collaboration between professionals and parents

Identify the living conditions related to the housing of children with autism spectrum disorders (ASD) treated at the Léo Kanner Center (CLK), psychopathology department of the Saint-Étienne University Hospital. The aim is to describe through the trajectories of children with ASD and their families, their living conditions, and through interviews with professionals who support them, how the specificities related to precarious situations are identified and taken into account.

A qualitative survey, carried out by sociological interviews with families whose children are followed at the Léo Kanner Center (CLK) and the professionals who care for them, would make it possible to collect data on the development of a young child with autism in his home and more generally in his habitat.

The purpose of this study is to study the specificities of families in a precarious situation with a child with autism spectrum disorders (ASD) in terms of housing, in order to better support them in different social spaces and improve collaboration between professionals and parents. The project aims to bring children with autism spectrum disorders (ASD) into a dynamic of access to human rights. He suggests three levers to achieve this: rely on a precise inventory of needs; work towards a transformation of representations; streamline access to healthcare and common law services.

Eligibility Criteria:
Inclusion Criteria:

* Families having their child followed in the child psychiatry service of the Léo Kanner Center (CLK),
* Children followed for Autism Spectrum Disorders (ASD),
* Families who received informed information about the study and who co-signed a consent to participate in the study with the investigator.

Exclusion Criteria:

* Opinion of the child's referring physician contraindicating inclusion
* Refusal of one of the legal guardians to participate in the study
A Clinical Study of ANX005 and IVIG in Subjects With Guillain Barré Syndrome (GBS)

This study is a multi center, open-label, study of ANX005 in combination with IVIg in subjects diagnosed with GBS.

The study will enroll approximately 12 subjects into one cohort, with subjects receiving 75 mg/kg of ANX005, a dose shown to be safe and well-tolerated as monotherapy and that provides a meaningful level of exposure to be tested in combination with IVIg. Dosing of IVIg will be administered as is the current standard of care (0.4 g/kg/day x 5 days) and ANX005 will be administered concurrently, beginning on Day 1 or 2 of the treatment period. Subjects will be followed for 6 months after treatment for observation and evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for Guillain Barré Syndrome
* Onset of GBS-related weakness ≤14 days prior to infusion
* GBS-DS score of 3, 4, or 5

Exclusion Criteria:

* Clinically significant findings that may interfere with the conduct of the study or the interpretation of the data
* Be at risk of suicide or self-harm
* Received previous treatment with plasma exchange for GBS
* Any diagnosis of a variant of GBS
* Have a history of anaphylaxis or severe systemic response to immunoglobulin
* Documented, clinically significant, pre-existing polyneuropathy from another cause
* Clinically significant intercurrent illness, medical condition, or medical history
* History of chronic use of steroid or immunosuppressant medication
* Active alcohol, drug, or substance abuse
* Females who are pregnant, breast feeding, or unable or unwilling to use highly effective methods of contraception throughout the study
Effectiveness of ACT for Problematic Chemsex

Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of problematic chemsex.

After being informed about the study, all patients giving written informed consent will be assessed to determine eligibility for study entry.

Patients who meet eligibility requirements will receive psychological intervention consisting in an 8-session individual on line-delivered ACT-based treatment.

The participants will be assessed through self-report instruments before and after treatment and at 3 months follow-up.

The clinical trial will include a control group.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years-old
* Spanish speaking
* having used psychoactive substances to facilitate, maintain and/or improve sexual relations in the last year
* significant score on the HBI Inventory (of 53 or more)
* clinically significant discomfort related to sexual practices
* degree of interference in his/her life of sexual practices greater than or equal to 5 out of 10
* desire to improve/reduce excessive sexual behaviour

Exclusion Criteria:

* receiving psychological or psychopharmacological treatment
* intellectual disability
* substance dependence (use not associated with sex)
* personality disorder or other serious or chronic mental disorder diagnosed
A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003

This study is to evaluate the human tolerance and pharmacokinetics of LY03003.


Eligibility Criteria:
Inclusion Criteria:

1. aged 18 to 45 years, no less than one-third of a single sex ratio;
2. normal physical examination items (including general physical examination, blood and urine, blood biochemistry, anti-HBV, anti-HCV, anti-HIV, pregnancy test, ECG, chest X-ray);
3. body weight not less than 50 kg, body mass index between 19 and 24 kg/m2;
4. during 2 weeks not using any drugs;
5. no history of drug allergy or drug allergy;
6. voluntarily participate in this clinical trial, can cooperate to complete the specified examinations, and sign the informed consent form

Exclusion Criteria:

1. abnormal health examination and clinical significance;
2. history of allergy to non-ergot dopamine agonists, or history of allergy to other drugs and food;
3. Bronchial asthma, epilepsy, mechanical intestinal obstruction, urinary tract obstruction;
4. history of liver and kidney disease, cardiovascular system, respiratory system, hematopoietic system, nervous and mental illness;
5. Women of childbearing age who have a positive pregnancy test or a negative pregnancy test but cannot ensure to take appropriate contraceptive measures during the study;
6. lactating women;
7. Male subjects who are unwilling to take appropriate contraceptive measures. Appropriate measures include the use of condoms, spermicides, or female partners using intrauterine devices (IUDs), ovarian caps, oral contraceptives, injected or subcutaneously implanted progestins, and tubal ligation surgery. Female partners must not be pregnant or lactating women;
8. smokers, alcoholics and drug abusers;
9. drinkers within 24 hours before medication;
10. used any drugs within 2 weeks before the trial; Use of drugs with effect on liver and kidney function within 11.3 months; Participated in other drug trials within 12.3 months, donated blood loss (≥ 200ml), or sampled as subjects;

13. Researchers believe that the participants are not suitable.
Electrical Impedance Tomography Monitoring and Invasive Mechanical Ventilation During Pronation in Acute Respiratory Distress Syndrome.

Acute respiratory distress syndrome is an acute form of lung injury. The most commonly used classification criteria for this syndrome are Berlin's Criteria. The actual literature underlines the advantages of prone position in mild or severe forms of ARDS in association with invasive mechanical ventilation. The hypothesis of this study is to investigate the effective ventilation and perfusion modifications during pronation assessed with clinical parameters and with the aid of the electrical impedance tomography.


Eligibility Criteria:
Inclusion Criteria:

* mild or severe ARDS according to Berlin's Criteria
* recruitment maximum 72 hours from the diagnosis of ARDS

Exclusion Criteria:

* other non-ARDS respiratory system pathologies
* hemodynamic instability (mean arterial pressure \< 60 mmHg)
* pneumothorax
* endocranial hypertension
* skin lesions or burns
* presence of pacemaker or implantable defibrillator
* pregnancy
Patient Time and In-hospital Delay of Surgery Association With Complicated Appendicitis

This is a retrospective observational study with its main aim of evaluating possible factors associated with complicated appendicitis. Current literature supports time from symptom onset until registration as the main and maybe only determinant of the outcome if patients are operated on within 24 hours. We wish to evaluate whether this is true in all patients, or there are subgroups in which time from registration to operation is associated with complicated appendicitis.

The data to be analyzed is that of patients operated on acutely for suspected appendicitis within 10 years in one medical center. Patients undergoing interval or incidental appendectomies will not be included. The endpoint to be evaluated is complicated appendicitis (gangrenous, abscess, perforated). The independent variables will include mainly sex, age, patient time (time from symptom onset to registration), hospital time (time from registration to operation), and missed diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* male and female patients of all ages who underwent appendectomy of acute appendicitis in a single medical center between December 1, 2006, and December 31, 2016

Exclusion Criteria:

* interval appendectomy,
* incidental appendectomy,
* appendectomy after failed antibiotic treatment for either acute appendicitis or peri-appendicular abscess
* patients with a non-inflamed appendix
* those in whom symptom onset before hospitalization was not noted.
Effect of a Nutritional Approach in Combination With Cognitive Stimulation on Child Cognitive Abilities

The objective of the study is to explore the impact of a combined intervention including a growing up milk (GUM) fortified in micronutrients and cognitive stimulation on cognitive abilities, mother-child- interaction and behavior in children of 3 to 5 years from less enriched home environments.

The objective of the study is to explore the impact of a combined intervention including a growing up milk (GUM) fortified in micronutrients and cognitive stimulation on cognitive abilities, mother-child- interaction and behavior in children of 3 to 5 years from less enriched home environments with HOME score less than 26. The control group will receive skimmed milk but no extra stimulation materials ( however, no restrictions on normal mother-child interaction). The cognitive abilities, mother-child interaction and child behavior will be assessed after a 6 months intervention.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female children, age 3;0-4;11 years
* Having obtained their legal representative's informed consent
* Level of stimulation in their home environment score below 26 in HOME inventory
* Normal cognitive development

Exclusion Criteria:

* Neurological disorders
* Food allergies (especially milk and soy allergy)
* Documented lactose intolerance
* Children with special nutritional needs
* Children under chronic (more than 7 consecutive days) medications which may impact cognitive performance
* Children not living in a family/children in foster homes
* Subject who cannot be expected to comply with study procedures
* Currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study
Return to Work After Total Knee Arthroplasty in Young Patients

This study takes its base in the augmenting number of primary total knee arthroplasty in the world whom quality and survey had permit to widen their indications to younger patients who are in the age of professional activity.

This work will focus on young patients under 55 who had had primary total knee arthroplasty, retrospectively, over the past 10 years, to determine the factors influencing early or late return to work, depending of socio economics factors.

This will optimize the information for the patient, and prepare him if necessary for a long work stop, and possibly obtain a better satisfaction for him.

The primary aim of this study is to determine the rate of young patients returning to work after a primary total knee arthroplasty and the mean delay, and to compare it to other studies.

The mean delay of return to work in the literature is between 8 to 12 weeks, with up to 98% of patients returning to work.

The investigators will next determine which category of patients could have a late return to work superior to 6 months, and also if the surgery could give back a professional activity to patients who were in a long work stoppage.

Eligibility Criteria:
Inclusion Criteria:

* first intention total knee arthroplasty
* Age at the time of surgery under 55

Exclusion Criteria:

* Not in capacity of completing a questionnaire
* revision of total knee arthroplasty
Identifying Prostate Brachytherapy Seeds Using MRI

This study will look at the feasibility of using a type of Magnetic Resonance Imaging called Susceptibility Weighted Imaging (SWI) to detect your implanted radioactive seeds. Researchers hope that using SWI will eliminate the need to use CT imaging to detect your implanted radioactive seeds.

This study will also see if the MRI seed detection is as effective as current standard practice of seed detection (routine MRI and CT imaging). This technique would be beneficial for brachytherapy without the need to fuse the MRI and CT images, as is done currently.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old
2. Histologic diagnosis of adenocarcinoma of the prostate
3. No contraindications for Pelvic body MRI
4. Patients undergoing LDR brachytherapy at PMH and scheduled for post implant analysis with CT-MR (standard at PMH)
5. Ability to provide written informed consent to participate in the study

Exclusion Criteria:

1. Contraindication for Pelvic body MRI
2. Patient not willing/consenting for this study
Long-Term Longitudinal QoL in Patients Undergoing EEA

This is a prospective longitudinal study to access postoperative 2-year quality of life in patients who undergo endonasal endoscopic approach surgeries of the skull base.

This is a prospective single-institution longitudinal study to access quality of life in patients who undergo endonasal endoscopic approach surgeries of the skull base. Patients will be followed before surgery and up to twenty-four months post-surgery. The primary goal of the study is to assess the alterations to patient quality of life following endoscopic endonasal surgery using modern sinonasal reconstruction techniques. Secondary goals are to better understand the time course of normal healing and patient/procedural risk factors associated with poorer quality of life outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patient is scheduled to undergo endoscopic endonasal surgery. Multiple, staged surgeries are not exclusionary
* 18 years of age or older
* The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent

Exclusion Criteria:

* Patient is a prisoner
* Patient is not English speaking
* Patient is not expected to survive until the 2-year follow-up