cyrilzakka/clinical-trials huggingface dataset:
Evaluation of LacTEST for the Diagnosis of Hypolactasia in Adults and Elderly Patients Presenting With Clinical Symptoms of Lactose Intolerance

The purpose of this study is to evaluate both the impact of LacTEST on diagnostic thinking and on patient management, and its reproducibility (Test-Retest), for the diagnosis of hypolactasia in adults and elderly patients presenting with clinical symptoms of lactose intolerance.


Eligibility Criteria:
Inclusion Criteria:

1. Adults of either sex, between 18 and 70 years old.
2. Capacity for understanding and giving the informed consent to participate in this study.
3. Patients with clinical suggestive of lactose intolerance, primary or secondary, who have not been diagnosed and that fulfil the requirements allowed by the gaxilose summary of product characteristics (SmPC).

Exclusion Criteria:

1. Pregnant women or breast-feeding women.
2. Unable or reticent to give the informed consent or to comply with the study requirements.
3. Patients with glomerular filtration rate (GFR) less than 90 ml/min/1.73m2.
4. Portal hypertension: ascites, cirrhosis.
5. Medical records of total gastrectomy and/or vagotomy.
6. Patients diagnosed with myxedema.
7. Patients with Diabetes Mellitus.
8. Patients who are participating or have participated in any clinical trial within the 3 months previous to their inclusion in the study.
9. Patients who are drug abuse consumers.
10. Patients under treatment with antibiotics, sulphamides and antiparasitics, who cannot suspend the treatments 7 days prior to the performance of the hydrogen breath test.
11. Patients with any recognized and already existing disorder that might interfere with the any of the lactose intolerance diagnosis tests.
12. Patients who have taken aspirin of indomethacin in the 48h preceding the performance of the Gaxilose test.
Observational Study to Evaluate Disease Course and Outcomes in Patients Treated With Esbriet (Pirfenidone) for Idiopathic Pulmonary Fibrosis (IPF) in Canada

This is a multi-center, non-interventional study to assess and describe course and outcomes in patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) who are treated with Esbriet (pirfenidone) in Canada, by measuring and reporting observed predicted forced vital capacity (FVC) change from baseline on an ongoing basis.


Eligibility Criteria:
Inclusion Criteria:

* \> or = 18 years of age
* Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
* Prescribed and/or currently taking Esbriet (pirfenidone) for the treatment of IPF

Exclusion Criteria:

* Hypersensitivity to Esbriet (pirfenidone)
* Concomitant use of fluvoxamine
* Severe hepatic impairment or end-stage liver disease
* Severe renal impairment or end-stage renal disease requiring dialysis
Weekly Paclitaxel Liposome Injection Plus Cisplatin in Preoperative Treatment of Breast Cancer

The purpose of this study is to evaluate the pathological complete response (pCR) rate in breast cancer patients treated with weekly paclitaxel liposome injection plus cisplatin preoperative regimen.


Eligibility Criteria:
Inclusion Criteria:

* Women aged ≥ 18 years and \< 65 years,An estimated life expectancy of at least 12 months
* ECOG 0-1
* At least one measurable disease according to the RECIST. histologically confirmed invasive breast cancer, stage II and III, no prior systemic or loco-regional treatment of breast cancer
* Biopsy specimens are available for ER, PgR and Her2 analysis
* Adequate bone marrow function: Neutrophil ≥ 1.5\*109/L; Hb ≥ 100g/L; PLT ≥ 100\*109/L
* adequate liver function (bilirubin \> 1.0 times upper normal limit \[UNL\] and ALT and/or AST\> 1.5 UNL associated with alkaline phosphatase \> 2.5 UNL;
* Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study
* No obvious main organs dysfunction
* patients must be accessible for treatment and follow-up and written informed consent

Exclusion Criteria:

* Patient is pregnant or breast feeding
* Inflammatory breast cancer and Metastatic breast cancer
* Patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitis, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
* History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP \> 180 mmHg or diastolic BP \> 100 mmHg)
* Has peripheral neuropathy
* Treatment with any investigational drugs within 30 days before the beginning of study treatment
* No psychiatric illness and other situations that would limit compliance of study
* With a history of other malignant tumor
* Known severe hypersensitivity to any drugs in this study
Mental Health Pathways in Internet Support Groups

People facing serious health threats increasingly use Internet health support communities to obtain informational support, emotional support and other resources. This study introduces software algorithms similar to those used by social media sites to put people in touch with helpful information and social interactions. Participants from the American Cancer Society's Cancer Support Network will have access to this online support group using the default interface that orders content by broad content category and date or with a new interface that highlights communication content and people that match users' interests and needs.

Internet support groups (ISGs) are online communities where people come together to exchange information, emotional support and other resources. They are an important resource for patients grappling with serious medical conditions. Although participation in health-related ISGs has been associated with significant reductions in participant-reported depression, anxiety and other indicators of psychological distress, many ISG members leave too soon to benefit. In a parallel study, we are using state-of-the art machine learning and automated language analysis techniques to assess the types of interactions that keep people participating in these groups and that lead to improved psychosocial well-being and health quality of life and how these interactions develop. The clinical trial described here uses these technologies and insights from our empirical research to build, deploy, and evaluate interventions that improve the interactions in Internet health support groups.

We will develop and pilot-test interventions to encourage effective communication processes identified in our empirical research. Participants from the American Cancer Society's Cancer Support Network will access this support group using either the default interface that orders content by disease diagnosis and date or with a new interface that sometimes highlights communication content and people who match their interests and needs. We will test whether mood, satisfaction with interactions and engagement in the group increase following interventions that (a) increase participants' receipt of individualized support from others; (b) provide participants with opportunities to offer support to others; (c) facilitate participants' expression of emotions; and (d) help participants form relationships with compatible peers. In a series of small, randomized experiments, we will examine how these interventions affect participants' communication behaviors as well as short-term engagement and satisfaction with their online interactions.

Eligibility Criteria:
Inclusion Criteria:

* Is an existing or new registrant to the American Cancer Society's Cancer Support Network.

Exclusion Criteria:

-
Real World Testing of a Brain-Computer Interface

The goal of this project is to test a new AAC-BCI device comparing gel and dry electrode headgear used for communication while providing clinical care. Innovative resources will be employed to support the standard of care without considering limitations based on service billing codes. Clinical services will include AAC assessment, AAC-BCI device and treatment to individuals with minimal movement due to amyotrophic lateral sclerosis (ALS), brain stem strokes, severe cerebral palsy, traumatic brain injury (TBI) and their family support person. This is a descriptive study designed to measure and monitor the communication performance of individuals using the AAC-BCI, any other AAC strategies, their user satisfaction and perceptions of communication effectiveness, and the satisfaction of the family support persons.

This clinical trial follows a descriptive study design collecting data to measure and monitor variables related to the standard of care in providing speech language pathology augmentative and alternative communication clinical (AAC) assessment and treatment. The study tracks participants through the AAC, speech generating device trial and AAC-BCI trial processes. In addition this study measures and monitors the communication performance of individuals using the AAC-BCI and any other AAC strategies for treatment in the home. Data on communication performance, user satisfaction, and perceptions of communication effectiveness are gathered over monthly visits along with the satisfaction and perceptions of communication effectiveness by the family support persons.

Eligibility Criteria:
Inclusion Criteria:

* natural speech does not meet daily communication needs requiring using a speech generating device
* Has a diagnosis resulting in minimal movement interfering with direct selection to a keyboard or AAC display
* age 14 and above
* able to read a standard computer screen
* able to follow instructions
* English as their native language

Exclusion Criteria:

* history of photosensitive epilepsy
* open sores on the scalp
* history of uncorrectable hearing loss
* unavailable to participate during the times scheduled for the study
Can Epimutations be Inherited? How to Manage Patients With Imprinting-related Diseases Who Wish to Become Parents

Like genetic mutations, DNA methylation anomalies or epimutations can disrupt gene expression and lead to human diseases.

However, unlike genetic mutations, epimutations can in theory be reverted through developmental epigenetic re-programing, which should limit their transmission across generations. Following the request for a parental project of a patient diagnosed with Silver-Russell syndrome (SRS), and the availability of both somatic and spermatozoa DNA from the proband and his father, we had the exceptional opportunity to evaluate the question of inheritance of an epimutation. We provide here for the first time evidence for efficient reversion of a constitutive epimutation in the spermatozoa of an SRS patient, which has important implication for genetic counseling.


Eligibility Criteria:
Inclusion Criteria:

* Men who have been informed about the study
* Patients over 18 years old
* Fertile
* Matched for age with Silver Russel syndrome (SRS) patients

Exclusion Criteria:

* Adults under guardianship
* Patients without national health insurance cover
* Patients with psychomotor development diseases or pulmonary, cardiac, renal or metabolic diseases (including type 1 and 2 diabetes before the pregnancy), inflammatory and systemic diseases, hypertension, neurological diseases, chronic hepatitis B or C, infection with human immunodeficiency virus (HIV).
Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant

This is a Phase 3 study to evaluate posoleucel (ALVR105, Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.

This is a Phase 2/3, multicenter, randomized, double-blind, placebo controlled trial comparing posoleucel to placebo for the prevention of infection or disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV in high-risk adult and pediatric patients after allogeneic HCT.

There are 2 parts to the study, a Phase 3 randomized study cohort described in this posting, and an open label Phase 2 cohort described in NCT04693637, which has completed enrollment. In this Phase 3 part, approximately 302 eligible allogeneic HCT recipients will be enrolled and will receive 7 doses of posoleucel or placebo over 12 weeks, followed by a 12 week follow-up period.

Eligibility Criteria:
Key Inclusion Criteria:

* Any age at the day of screening visit.
* No known or suspected clinically significant disease from AdV, BKV, CMV, EBV, HHV-6, and/or JCV
* Within 25 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment at time of dosing
* Meet one or more of the following criteria at the time of randomization:

  * Related (sibling) donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B or -DR
  * Haploidentical donor
  * Matched or Mismatched unrelated donor
  * Use of umbilical cord blood as stem cell source
  * Ex vivo graft manipulation resulting in T cell depletion
  * Received anti-thymocyte globulin or alemtuzumab (Campath-1H)

Key Exclusion Criteria:

* History of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease within 6 months prior to randomization
* Evidence of active Grade \>2 acute GVHD
* Presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections
* Known history or current (suspected) diagnosis of Grade ≥3 CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies
* Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose \>1.0 mg/kg/day) within 24 hours prior to dosing
* Relapse of primary malignancy other than minimal residual disease

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Comparison of Image Quality Between Ultra-low Dose (ULD) and Standard Dose CT Scans in Detecting Traumatic Brain Injury in the Emergency Room

Head trauma is a frequent reason for consultation in the emergency room. The CT scan is the reference examination allowing rapid management of the patient. However, CT examinations are among the diagnostic examinations with the highest exposure to ionizing radiation. The study investigators have previously implemented "ultra-low dose" (ULD) acquisitions for several pathologies with an effective dose level similar to that of a standard radiographic examination. These ULD acquisitions are now routinely used in our clinical practice for explorations of the thorax, spine, pelvis and proximal femurs, extremities.

This study expands these ULD acquisitions to skull CT for detecting traumatic intracranial lesions.

The study investigators hypothesize that it would be possible to search for intracranial lesions in patients with head trauma using ULD protocols, thereby reducing the doses delivered to the patient while maintaining sufficient image quality for the diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient presenting to the emergency room of the CHU of Nîmes for a cranial trauma requiring scanning.
* Patient with isolated head injury or polytrauma patient with head injury among others.
* The patient or their legal representative or family member must have given their free and informed consent and signed the consent form, or the patient was included under an emergency situation
* The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

* The subject is participating in a study prohibiting participation in other studies, or is in a period of exclusion determined by a previous study
* Patient is pregnant, parturient or breastfeeding
Radiofrequency Ablation for Amiodarone-induced Thyrotoxicosis

Investigators intend to study the changes in thyroid hormone storage and production in amiodarone-induced thyrotoxicosis patients after RFA therapy.

Investigators plan to identify patients with amiodarone-induced thyrotoxicosis (AIT) that failed to respond to medical therapy or have developed side effects from medical therapy or are considered high risk for such therapy.

These patients will be offered the option to undergo radiofrequency ablation (RFA) of a portion of the thyroid gland in order to decrease thyroid hormone production and/or to inactive the existing thyroid hormone store before their leakage into the circulation.

Investigators will follow these patients to assess their clinical response as well as their thyroid values. The safety of the procedure will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Are adults
* Have overt thyrotoxicosis (within 2 weeks prior to enrollment)
* Are receiving medical therapy for AIT
* Are able to understand the study procedures and to comply with them for the entire length of the study
* Have not normalized their thyroid levels after one month of standard therapy or
* Have persistent and clinically significant thyrotoxicosis (less than 25% decrease in T4 value or patients requiring hospitalization with Congestive heart failure (CHF), tachyarrhythmias, hemodynamic instability or similar co-morbidities) after 2 weeks of standard therapy where additional medical therapy is deemed unlikely to be beneficial or with high risk of side-effects (e.g. hepatotoxicity of antithyroid medications, agranulocytosis of potassium perchlorate or ATD or fluid retention associated with steroids).

Exclusion Criteria:

* Pregnancy
* Patients with prior neck surgery or neck radiation
* Patients with neck anatomy that precludes easy access by RFA to the entirety of thyroid parenchyma
* Patients on anticoagulation therapy
* Patients with comorbidities deemed too high of a risk for general anesthesia
* Treatment with another investigational drug or intervention (within 6 weeks of planned RFA).
* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Assessment of Tube Position According to the Changes of Neck Position Between Two Different Types of Nasotracheal Tubes

The aim of this study is to evaluate the appropriateness of the two kinds of nasotracheal tube (PORTEX POLAR \[Smiths Medical International, Hythe, United Kingdom\], Mallinckrodt TaperGuard \[Covidien, Ireland\]) depth in neutral, extended and flexed neck position when the upper border of the cuff of endotracheal tube is located 3cm below the vocal cords in neutral neck position.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients who undergoes elective surgery under general anesthesia with nasotracheal intubation

Exclusion Criteria:

1. Patients under 20 years old
2. Patients with ASA class IV or higher
3. Pregnant women
4. Patients receiving emergency surgery
5. Patients who have nasal disease or who undergo nose surgery because of nasal disease
6. Patient with craniofacial anomaly
7. Patients with impaired cervical motion
8. Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner)
9. Patients who refused the clinical trial Patients with dementia or cognitive impairment
Genetics of Fatty Liver Disease in Children

This is a study to investigate genetic predisposition to hepatic steatosis and the expression of gluconeogenic and lipogenic genes in livers of obese children and adolescents.

Hypothesis 1: Common variants recently associated with variation in plasma TG levels identified in Genome Wide Association Studies (GWAS) (such as GCKR, PNPLA3) can affect accumulation of fat and subsequent development of Non Alcoholic Fatty Liver Disease (NAFLD). Gene variants act in additive or synergistic manner with progressive liver fat accumulation per additional risk allele.

Hypothesis 2: With increase in hepatic fat content NASH and fibrosis will increase. Furthermore, expression of lipogenic markers (SREBP1c) will increase.

To establish a cohort of obese youths to prospectively analyze potential factors (genetic and nutritional factors) that might affect the expression and progression of NAFLD. This study will determine genetic markers and their ability to convey susceptibility to NAFLD in obese children and adolescents. Furthermore, potential mechanisms that might contribute to the accumulation of hepatic Triglyceride (TG) accumulation will be, for the first time, assessed by genotyping. Additionally, we will examine the presence of intestinal microbiome in the development of fatty liver through stool collection.

Eligibility Criteria:
Inclusion Criteria:

* between 7 and 18 years of age,
* overweight or obese with a BMI greater than the 85th percentile for age and gender, and
* be otherwise healthy.

Exclusion Criteria:

* the use of any medication that alters liver function, blood pressure, glucose or lipid metabolism and
* no use of any antipsychotic medication
* Youth on chronic anti-inflammatory medications or who consume alcohol are also excluded.
Orthostatic Tolerance in Mamma Cancer Patients After Anaesthesia

The investigators want to investigate the effect of anaesthesia, on the ability to maintain upright posture immediately after surgery in mamma cancer patients.

The investigators hypothesis is, that a standard anaesthesia does not effect the ability to maintain upright posture right after surgery.

It is known, that patients undergoing major surgery have problems maintaining upright posture after major surgery. This can be due to fall in bloodpressure, with symptoms like dizziness, nausea/vomiting and fainting.

With this investigation, we want to prove that anaesthesia is not the decisive factor, in patients ability to maintain upright posture after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients having performed elective breast surgery
* Age between 18 and 70 years
* Patients who have given written consent to participate in the project after haven completely understood the contents and limitations of the protocol

Exclusion Criteria:

* Patients who do not understand or speak Danish
* Patients who have not signed the informed consent or the written authority pre-medication, except 1g paracetamol
* ASA \> II
* Pregnant or breastfeeding
* Known to have Renal disease
* Known to have Psychiatric disorder (not considering the use of SSRI antidepressive)
* Need for crash induction or prone position
* Oesophageal varicoses
* Necrosis or cancer in: Mouth, Pharynx, Larynx or Oesophagus
* Coarctation or aneurism in the proximal Aorta
* Severe bleeding disease
Gastroprotective Agent Compliance in Patients at Risk Suffering From a Gastrointestinal(GI) Ulcer

The purpose of this study is to assess gastroprotective agent compliance in patients at risk suffering from a gastrointestinal bleeding ulcer or a symptomatic ulcer with NSAID.


Eligibility Criteria:
Inclusion Criteria:

* Patients at risk suffering from a gastrointestinal bleeding ulcer or a symptomatic ulcer confirmed by endoscopy