cyrilzakka/clinical-trials huggingface dataset:
Interest of Pregabalin (Lyrica) on the Treatment of Reflex Earache in Head and Neck Cancer.

Referred otalgia is one of the symptoms of oropharynx and hypopharynx cancer. It can be primary (otodynia) or secondary (referred otalgia and projected pain). The mechanism of referred otalgia involves several non adjacent nerve territories as those of head, neck or ear. Referred otalgia is a projected pain due to injury (most of the time cancer) localized far from the ear but sharing the same innervation. In this contest, the otoscopy is normal.

Four cranial nerves participate in the sensory innervation of the external ear: the trigeminal nerve (V) via the auriculo temporal nerve (V3), the facial nerve (VII) for the Ramsay-Hunt's zone with the conch, tragus, antitragus, a part of the anthelix, of the external auditory meatus and of the eardrum, the glossopharyngeal nerve (IX) via the Jacobson's nerve for the external ear canal and the C2 and C3 cervical plexus. However, there are important interindividual anatomical variations.

The relationship between referred otalgia and probable nerve damage has been described. In he oropharynx and hypopharynx, the proximity of the sensory innervation of the ear can then explain the otalgia during the cancer progression. Then referred otalgia has a neuropathic component.

In the literature, the curative treatment of referred otalgia is the cancer treatment. However, the high intensity of referred otalgia leads the patients to a large consumption of analgesics in particular of opioids. These latter are particularly adapted for pain resulting from excess of nociceptive stimulation. Pregabalin (Lyrica®) is an analogue of gamma aminobutyric acid. This molecule binds to alpha subunit 2 delta 1 calcium dependent voltage channels in the central nervous system. its effectiveness has been demonstrated for the treatment of neuropathic pain on diabetic neuropathy, post herpetic neuralgia, lesions in the bone marrow but also the postoperative pain when the molecule is administered after the surgery. The anti hyperalgesic activity of pregabalin is at a dosage of 150mg/day in two or three daily doses.

The purpose of this study was to evaluate the activity of pregabalin administered orally for three weeks after the anesthesia consultation on the intensity of the pain of referred otalgia and on its neuropathic component.


Eligibility Criteria:
Inclusion Criteria:

* referred otalgia
* ENT cancer
* ASA score 1,2 or 3
* understanding protocol
* information and free and informed consent

Exclusion Criteria:

* ASA score 4 et 5
* allergy or intolerance of pregabalin
* creatinin clearance inferior of 50ml/min (Cockcroft formula)
* liver failure
* cardiac failure
* history epilepsy
* ant hyperalgesic treatment
* minor or disabled adult
* intellectual disabilities that prevent the understanding of the protocol
* uncooperative patient
* pregnant women
* patient participating in another research protocol
* lactose intolerant patient
Gluten and Amylase Trypsin Inhibitors (ATI) Free Diet

Siblings of those with type 1 diabetes are at an increased risk of developing the disease themselves. Through prior research, the investigators have found that siblings as well as those with type 1 diabetes have a general level of inflammation in the body. The investigators are examining the role that diet plays in this level of inflammation by asking siblings of children with type 1 diabetes to go on a gluten and Amylase Trypsin Inhibitors (ATI)-free diet for 4 weeks. Blood and stool samples will be measured before the diet, after the diet is completed and again 4 weeks after participants resume their normal diet.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females 2-23 years of age
2. Full-sibling of an individual with a clinical diagnosis of type 1 diabetes
3. Treatment naïve of any immunomodulatory agent

Exclusion Criteria:

1. Abnormal HbA1c, defined as ≥ 6%
2. Previous or current use of a gluten-free diet
3. Current diagnosis of celiac disease
4. An elevated tissue transglutaminase IgA level (\> 10 units/mL)
5. Chronic (≥ 3 months duration) gastrointestinal disease or presence of gastrointestinal symptoms within the prior 6 weeks (e.g., abdominal pain, worsening constipation, diarrhea, or recurrent nausea +/- vomiting)
6. Chronic inflammatory or autoimmune disease with the exception of well-controlled hypothyroidism or intermittent or mild persistent asthma not requiring the use of daily inhaled steroids
7. Use of any medications that affect glucose metabolism (e.g., metformin) or the immune system (e.g., use of any glucocorticoids (inhaled, intranasal, oral, intravenous) within the previous 3 months)
8. Use of any medications that could affect intestinal microbiota within the previous 3 months (e.g., antibiotics, prebiotics, or probiotics)
9. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results
Liquid Biopsy for Early Non-small Lung Cancer Detection

This clinical trial will assess the performance of a liquid biopsy assay to identify cancer in indeterminant pulmonary nodules identified by CT screening of high-risk individuals and evaluate the capability of the liquid biopsy assay to monitor response to surgical resection.

This clinical study examines the feasibility of a liquid biopsy methylation assay to detect non-small lung cancer. First, the investigators will apply their liquid biopsy assay to screen for lung cancer in indeterminate pulmonary nodules suspicious for cancer. Second, the investigators will assess the utility of liquid biopsy to assess tumor dynamics after surgical resection with curative intent. Third, the investigators will assess the presence or absence of this methylation assay in healthy normal persons without a history of lung cancer.

Eligibility Criteria:
Indeterminate pulmonary nodule study cohort

* Inclusion criteria: Patients undergoing a biopsy of an indeterminate lung nodule by surgical excision, bronchoscopic biopsy or Interventional Radiology directed biopsy
* Exclusion criteria: No known concurrent cancer

Known lung cancer for surgical resection study cohort

* Inclusion criteria: Patients with known non-small cell lung cancer who will have surgical resection for treatment
* Exclusion criteria: N/A

Healthy volunteer cohort

* Inclusion criteria: Healthy persons
* Exclusion criteria: No known current cancer or history of cancer within 5 years

Benign lung disease cohort

* Inclusion criteria: Patients with the following categories of benign lung disease: COPD/emphysema, Granulomatous infection, Interstitial lung disease including pulmonary fibrosis and interstitial lung disease.
* Exclusion criteria: N/A
A Phase 1 Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers

The purpose of this study is to evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers and to characterize the single-dose PK of ALN-4324.


Eligibility Criteria:
Inclusion Criteria:

* Has a body mass index (BMI) of ≥27 kg/m\^2 and \<40 kg/m\^2

Exclusion Criteria:

* Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection

Note: other protocol defined inclusion/exclusion criteria apply
Systemic Inflammatory Response Syndrome (SIRS) in Patients Undergoing Major Procedures in Oral and Maxillofacial Surgery

Patients undergoing major procedures in oral and maxillofacial surgery more often develop a systemic inflammatory response syndrome (SIRS) in the first days of postoperative critical care therapy than patients with a comparable major surgery in other regions. The reasons for this finding are unknown and have not been studied in depth so far. We hypothesize that surgical trauma in this region might activate pro-inflammatory pathways. By examining the proteome of patients at different stages (prior to the surgery, at ICU admission, on the second postoperative day and when SIRS has ended clinically), we aim to identify the involved pro-inflammatory pathways and identify possible target proteins that might be clues to modification of postoperative SIRS in the future.


Eligibility Criteria:
Inclusion Criteria:

* age 18-99yrs
* scheduled for elective surgery with risk for development of SIRS
* written and informed consent

Exclusion Criteria:

* age \<18yrs
* pregnancy
* emergency surgery
* failure to obtain patient consent
Collection of Primary Human

Treatment and prevention of respiratory infections are of great interest in many medical areas. Create a physical device covered by primary human nasal cells could be very usefull in order to analyse delivery and efficiency of drugs. In this context the aim of this project is to create a collection of primary cells from the human nasal epithelium.

This collection will be realised during programmed surgery, thanks to a specific device dedicated to collect nasal cells. Then the cells will be sent to the lab in order to grow at the air-liquid interface, which is an excellent 'ex vivo' model for their study.

The treatment and prevention of respiratory infections caused by emerging viruses or antibiotic-resistant bacteria are major societal and medical challenges. Inhalation allows drugs to be administered in the form of a spray or aerosol, directly into the respiratory tract (nose or lung). This is a validated approach for the non-invasive delivery of drugs to prevent and treat respiratory diseases, particularly infectious ones. Primary human nasal cell cultures grown at the air-liquid interface are an excellent 'ex vivo' model for their study in a physiological and pathophysiological context, and for testing new therapies, including aerosols. In addition, this culture model also offers an alternative to animal experimentation.

The aim of this project is therefore to create a collection of primary cells from the human nasal epithelium.

The main objective is to obtain a minimum of 60 samples of nasal epithelial cells from patients that can be cultured in air-liquid interface. The secondary objectives are to be able to study these nasal cells under physiological and pathophysiological conditions. The cells will first be amplified to constitute a cell biobank. They will then be studied under physiological conditions (anatomical and functional characterisation). Finally, they can be used to establish different models of infection or inflammation, in order to test future aerosol drugs.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age \> 18 years) whose native language is French, or who understands French.
* Affiliation with a French social security system (CMU accepted).
* Informed consent, written and signed by the participant.
* Planned rhinological surgery (meatotomy, septoplasty or turbinoplasty for example, but other surgeries as well)

Exclusion Criteria:

* Patients under court protection, guardianship or curatorship.
* Pregnant or breast-feeding women (positive pregnancy test for women of childbearing age).
* Patients presenting a major alteration of the mucosa or a malignant rhinosinus pathology.
Protein-Distinct Macronutrient-Equivalent Diet 1

Plant-based diets are naturally low in Methionine (Met), and also low in precursor molecules (e.g L-carnitine, choline, betaine, etc.) producing microbiota-mediated proatherogenic TMAO. Among plant proteins, pulses are rich in micronutrients, and dietary fibers, making them ideal for microbiome-stimulating, nutrient-dense, healthful dietary patterns. However, daily pulse intake remains low at 8% in America despite recommendations by DGA, a resource to guide health promotion across communities. A significant body of preclinical data, waiting to be translated to humans, suggests that dietary Met restriction can trigger beneficial metabolic and anti-inflammatory adaptations leading to improved chronic health and longevity. The central hypothesis is that a pulse-protein-based healthy diet can be simultaneously equivalent to omnivorous diets in protein content and yet naturally lower in Met and TMAO to improve glycemic control, body composition, and immunometabolic flexibility to reduce the risk of chronic diseases and improve healthspan. The goal is to systematically elucidate for the first time the effects of a lacto-vegetarian feeding pattern with pulses as the primary protein source on a comprehensive panel of \~500 traditional and next-generation biomarkers of health, and assess the role of the gut microbiota in mediating such effects. We also aim to interrogate the potential concern about the lower bioavailability of non-heme iron from pulses.


Eligibility Criteria:
Inclusion Criteria:

* Generally good health status based on routine physical in the past 12 months, current healthy status
* Normal HbA1C, not underweight
* Age 60 years or more, all races, both sexes and all education level
* Do not have any special dietary requirements and willing to consume vegetarian diet
* Willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.

Exclusion Criteria:

* Probiotic, long-term antibiotic, and tobacco/drug/alcohol use
* Not on any special diet within 3 months of recruitment
* Impaired kidney functions
* Active history of cancer, diabetes, heart, liver, and kidney diseases
* Major gastrointestinal disorders in the past 3 months
* History of heart attacks or stroke
* Unable to meet in-person visit requirements for dining, picking up meals, and tests
* Any mental health condition that would affect the ability to provide written informed consent.
* If they had not had a routine health checkup during the 12 months prior to recruitment.
* If they were unwilling to abstain from taking certain nutritional supplements, alcohol, or non-study foods during the study period.
Improving Outcomes Using Technology for Children Who Are DHH

This study evaluates the efficacy of using augmentative and alternative communication (AAC) technology for enhancing language development in children who are deaf or hard of hearing. Half of the participants will receive AAC technology with their speech and language therapy and half will continue with their usual care models.


Eligibility Criteria:
Inclusion Criteria:

* documented permanent bilateral hearing loss with severity levels clinically defined in any range (mild to profound);
* identified with a language gap;
* currently receiving speech-language therapy.

Exclusion Criteria:

* primary language other than English
* significant motor impairments
* nonverbal IQ \<60
* children with severe communication disorders (i.e. autism spectrum disorders).
CUTE (Chronic Urticaria Treatment Evaluation)

A study to compare the clinical efficacy and safety of Levocetirizine vs. Desloratadine in patients suffering from Chronic Idiopathic Urticaria (CIU) measured by the mean pruritus severity score over the first week of treatment


Eligibility Criteria:
Inclusion Criteria:

- At visit 1: Clinical history of Chronic Idiopathic Urticaria for a period of at least 6 weeks during the last 3 months without an identifiable cause

- At visit 2 (after a baseline period of at least 3 days): patient with adequate signs of CIU, both in terms of symptoms and severity.

Exclusion Criteria:

- Any condition that would interfere with the evaluation of the therapeutic response.
Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Colorectal Cancer

RATIONALE: Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances, such as radioactive iodine, to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients with advanced colorectal cancer.

OBJECTIVES: I. Define the toxicity and determine the maximum tolerated dose of iodine I 131 humanized monoclonal antibody A33 (131I-huAb A33) in patients with advanced colorectal cancer. II. Describe pharmacokinetics and biodistribution of 131I-huAb A33 by external imaging in these patients. III. Determine the effect of human antihuman antibody response on pharmacokinetics and targeting of 131I-huAb A33 in this patient population. IV. Determine whether the dose planning methodology used here can adequately and safely be applied to routine radioimmunotherapy planning.

OUTLINE: Patients receive iodine I 131 humanized monoclonal antibody A33 (131I-huAb A33) by IV infusion over 20 minutes every 6-8 days for up to 8 weeks (depending on dosage). Patients receive a minimum of 6 weeks of treatments. In the absence of disease progression or unacceptable toxicity, patients are retreated no sooner than 6 weeks after the previous course. Cohorts of 3-6 patients receive escalating doses of 131I-huAb A33 to determine the maximum tolerated dose (MTD). The MTD is defined as the highest dose at which no more than 2 of 6 patients experience dose limiting toxicity. Patients are followed for 6 weeks after the last treatment.

PROJECTED ACCRUAL: There will be 3-24 patients accrued into this study over 16 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed advanced colorectal cancer Must have unresectable (Stage IV) disease or have failed or refused conventional chemotherapy Measurable disease by conventional imaging methods Liver involvement no greater than 50% No CNS involvement Not positive for human antimouse antibody titer

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 150,000/mm3 Prothrombin time less than 1.3 times control Hepatic: Bilirubin no greater than 1 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No significant cardiac disease (New York Heart Association class II/IV heart disease) Other: No serious infection requiring treatment with antibiotics No other serious illness Not pregnant or nursing Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior mouse monoclonal antibody or antibody fragment, chimeric or humanized antibody, or constructs derived from antibodies At least 4 weeks since prior immunotherapy Chemotherapy: No prior mitomycin/radiotherapy combination At least 4 weeks since prior chemotherapy Endocrine therapy: No concurrent steroids or other antiinflammatory agents Radiotherapy: No prior radiotherapy/mitomycin combination Surgery: Not specified
The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age

This is a phase IV, open label, prospective, one phase pharmacokinetic and observational study.

Twenty HIV-1 infected subjects will be recruited, subjects will switch antiretroviral therapy to:

* tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus
* raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24 hour pharmacokinetic visit.

This is a phase IV, open label, prospective, one phase pharmacokinetic and observational study.

Twenty HIV-1 infected subjects will be recruited. Eligible subjects will currently be receiving stable antiretroviral therapy with undetectable plasma HIV RNA and have no evidence of previous HIV- resistance mutations on genotypic resistance testing.

At baseline, subjects will switch antiretroviral therapy to:

* tenofovir/emtricitabine 245/200 mg daily (Truvada™) plus
* raltegravir 400 mg twice daily On day 28, all subjects will attend for an intensive 24 hour pharmacokinetic visit.

Follow up over 6 months, subjects will attend on days 14, 90 and 180 for follow up visits that will include standard safety parameters. Assessment of cardiac biomarkers at baseline and on days 90 and 180 and assessment of neurocognitive function at screening, baseline and on day 180 will also be undertaken.

Following completion of this study, subjects will recommence their usual antiretroviral treatment regimen and attend for a study follow up visit.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-1 infected males or females
2. 60 years of age or greater\*
3. signed informed consent
4. willing to switch therapy as per study protocol
5. no previous exposure to raltegravir or HIV-1 integrase inhibitors
6. plasma HIV RNA \< 50 copies/mL at screening and on at least one other occasion over the last 3 months
7. currently receiving a stable antiretroviral regimen with no antiretroviral drug switches for at least 3 months
8. no previous clinically-significant resistance documented on HIV-1 genotypic resistance
9. subjects in good health upon medical history, physical exam, and laboratory testing
10. BMI above or equal to 18 and below 32
11. Male subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom with spermicide) during heterosexual intercourse, from screening through completion of the study.
12. Have local screening laboratory results (haematology and chemistry that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical significance \* 50% of total enrolled cohort will be 65 years of age or over. Subsequent to 10 subjects aged between 60 and 64 recruited, only subjects aged 65 or over will be eligible.

Exclusion Criteria:

1. current alcohol abuse or drug dependence
2. positive urine drug of abuse screening
3. active opportunistic infection or significant co-morbidities
4. current disallowed concomitant medication
Analysis of Influencing Factors of Gastric Preparation Quality for MCCG

The invention of magnetically controlled capsule gastroscopy makes the movement of capsule endoscope in the body controllable. Endoscopic doctors can adjust the angle of capsule observation to examine gastric mucosa according to the need of examination. However, The presence of food residue, air bubbles, mucus and bile in the gastric cavity will affect the observation of gastric mucosa by capsule endoscopy. it will reduce the completion rate of capsule endoscopy, and even lead to misdiagnosis and missed diagnosis. The purpose of this study is to explore the factors affecting the quality of gastroscopy gastric environmental preparation of magnetically capsule.

Magnetically controlled capsule endoscopy is different from ordinary electronic gastroenteroscopy, it can not fill and clean the gastric cavity by water injection. The presence of food residue, air bubbles, mucus and bile in the gastric cavity will affect the observation of gastric mucosa by capsule endoscopy, reduce the completion rate of capsule endoscopy, and even lead to misdiagnosis and missed diagnosis, so the quality of MCCG gastric environmental preparation is an important factor limiting the accuracy of diagnosis of gastric lesions. We design the case report table by consulting the literature, and then collect patient information, and speculate the relevant influencing factors through the evaluation of the quality of gastric environmental preparation of the examination results. the ultimate goal is to reduce the missed diagnosis rate and misdiagnosis rate and the waste of clinical resources, to prepare the gastric environment more pertinently, and to provide certain guiding significance for the preparation of gastric environment in clinical magnetically controlled capsule endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18-75 years old who intend to undergo magnetron capsule gastroscopy, regardless of gender
* sign informed consent form

Exclusion Criteria:

* dysphagia, known or suspected gastrointestinal obstruction、stricture and fistula
* patients with severe somatic diseases unable to complete examination
* known active upper gastrointestinal bleeding
* previous history of upper digestive tract or abdominal surgery to change
* gastrointestinal anatomy
* patients with cardiac pacemakers or implanted with other electronic medical
* instruments and magnetic metal foreign bodies
* pregnant women
* claustrophobia or other mental disorders uncontrollable