cyrilzakka/clinical-trials huggingface dataset:
MCE Direct Visualization of Drug Behavior in Upper-gastrointestinal Tract

The investigators aim to explore the feasibility of MCE in direct, real-time visualization of drug behavior in upper-gastrointestinal tract, which presented by the adhesion, distribution, and dissipation characteristics of dyed sucralfate gel.

This pilot study was a prospective, single-centered, nonrandomized study. The investigators selected 10 subjects from patients with a recent history of upper-gastrointestinal symptoms who met the indication of taking sucralfate suspension gel, and another 10 subjects from healthy volunteers.

Procedures were performed by the NaviCam magnetic capsule guidance system. To enhance discrimination, the sucralfate gel dyed with 0.3 ml methylene blue. The subjects swallowed the capsule with water in the left lateral position. When capsule enter stomach cavity, subject was asked to sit up and ingested 4 g aerogenic powder with 5 ml water to distend the stomach, and performed gastric baseline examinations to identify the lesions. After baseline examination, subjects ingested dyed sucralfate gel and performed the first-time examination. The examination was repeated at 30 min intervals, until dyed sucralfate gel disappeared completely. When study completed, the capsule was detached from string and continued into the small bowel for further examination.

The endoscopists recorded the adhesion and dissipation times of dyed sucralfate gel, calculated the efficient time, and selected the images of six primary anatomic landmarks from each examination to measure the distribution area (%) . Any complication or discomfort during the procedure was evaluated. The discomfort was scored on a scale from 0 to 3 (0 = no; 1 = mild/minimal; 2 = moderate; 3 = sever/very difficult).

Eligibility Criteria:
Inclusion Criteria:

* With or without gastrointestinal complaints
* Scheduled to undergo a capsule endoscopy for both stomach and small bowel
* Signed the informed consents before joining this study

Exclusion Criteria:

* Suspected or known gastrointestinal stenosis
* Obstruction or other known risk factors for capsule retention
* Pregnancy or suspected pregnancy
* Pacemakers or electromedical devices implanted
* Any other contraindications determined by endoscopists
Evaluation of Effectiveness of Nutritional Practical Counseling for Elderly Patients at Risk of Malnutrition on Nutritional Status at Home

At hospital, short term actions are used (adaptation of meals, oral supplementation...) to fight malnutrition. Oral supplementation can have a positive impact on weight gain. But actions should continue at home, particularly to maintain autonomy for elderly. The hypothesis is that practical workshop about enrichment and interest of foods can help malnourished patients to change their eating habits. The main goal of this study is to evaluate the effects of this workshop on improving nutritional status, measured by Mini Nutritional Assessment

This is a mono center cohort study of a 4-months follow-up on elderly patients after hospitalization.

Nutritional parameters and evaluation of the quality of life will be collected during hospitalization and output during a visit at 4 months at home. These parameters will be studied in two groups : nutritional workshop vs usual dietary counseling

Eligibility Criteria:
Inclusion Criteria:

* malnourished patients or at risk of malnutrition
* coming back home after hospitalization
* affiliated to a social security system
* having given free, informed written consent

Exclusion Criteria:

* Mini Mental Score \<18
* Incapacitated adults and psychiatric inpatients
* Diet indication requiring strict salt restriction
* Severe swallowing difficulties
* Patients with artificial nutrition (enteral or parenteral)
* Impossibility to measure weight at home
* Severe digestive or intestinal malabsorption
* Iterative nausea and vomiting
* Patients with rapidly progressive diseases (life expectancy less than 6 months)
A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)

The purpose of this study is to determine the onset of action of two commercially available over-the-counter antihistamines (Loratadine and

Fexofenadine) in a model of seasonal allergic rhinitis (SAR). Participants undergo sensitization exposures to Mountain Cedar (juniperus ashei) pollen in a Biogenics Research Chamber; those who demonstrate an adequate allergic response determined by the Major Symptom Complex (MSC) score will then receive drug.


Eligibility Criteria:
Inclusion Criteria:

* Female participants of child bearing potential must demonstrate a negative

urine pregnancy test at Screening (Visit 1) and Visit 4 (prior to randomization) and agree to use (and/or have their partner use) 2 acceptable methods of birth control beginning at the Screening visit and throughout the study.

* Willing to stop use of current decongestant and allergy medications at the start of the washout period (Visit 1) and during the trial.
* Documented history or participant-reported history of seasonal allergic rhinitis caused by mountain cedar pollen within the last 2 years and documented or participant-reported symptoms over at least the last 2 mountain cedar allergy seasons.
* Documented skin testing (prick with wheal ≥ 4 mm larger than the diluent) within the last 1 year to mountain cedar pollen present.
* Capable of reading English.
* Body mass index (BMI) \<35.

Exclusion Criteria:

* Any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of loratadine, fexofenadine or might interfere with the trial. These may include thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, prostatic hypertrophy.
* Have started allergen immunotherapy within 1 month preceding enrollment or participants starting allergen immunotherapy or anticipating immunotherapy dose change during the trial. Xolair (omalizumab) may not be used within 4 years prior to trial participation.
* Known allergy or intolerance to loratadine, desloratadine, or fexofenadine.
* History of rhinitis medicamentosa.
* Use of systemic (oral, rectal, injectable), topical (up to 1% topical hydrocortisone is permitted), or nasal corticosteroids in the last 30 days or current or expected use of disallowed medications as listed in the protocol.
* Asthma, with the exception of mild intermittent asthma.
Ig NextGen 10% in Patients With Primary Immune Deficiency (PID)

This study aims to assess the safety, tolerability and pharmacokinetics of Ig NextGen 10% in patients with primary immune deficiency currently being treated with Intragam P. Eligible patients will switch from 3 to 4 weekly intravenous Intragam P therapy to receive seven cycles of Ig NextGen 10% treatment administered intravenously at three- to four-weekly intervals. Patients will be monitored on the study for up to 36 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PID
* = or \>6 month use of Intragam P at three- or four-weekly intervals
* = or \>6 month history of IgG trough levels of ≥ 5 g/L

Exclusion Criteria:

* Newly diagnosed PID within six months prior to Screening
* Known selective IgA deficiency or antibodies to IgA
* Immunosuppressive treatment other than topical and/ or inhaled steroids and/ or low dose oral steroids
* Protein-losing enteropathies, or kidney diseases
* History of malignancies of lymphoid cells
* Any of the following laboratory results at Screening:
* Serum Creatinine \> 1.5 times the upper normal limit (UNL)
* AST or ALT concentration \> 2.5 times the UNL
* Albumin \< 25 g/L
A Brief Dental Office Intervention With Tobacco Quitline

The novel and exploratory nature of this intervention relates to the concept of incorporating patient-specific oral health information obtained during a dental hygiene visit into the tobacco quitline counseling. Linking the patient-specific oral health information obtained during the dental hygiene visit to the tobacco quitline counseling will close the therapeutic loop for oral health professionals and make them a focal point for the tobacco use intervention without increasing clinical burden.

The overarching hypothesis of this line of research is: A brief office intervention with proactive tobacco quitline counseling incorporating patient-specific oral health information obtained during a dental hygiene visit (intervention) will increase prolonged abstinence rates from cigarette smoking compared to a brief office intervention alone (control) at 3 and 6 months.To test our overarching hypothesis in a Phase III clinical trial, we are first seeking R21 funding through the NIDCR Clinical Pilot Data Grant (PAR-03-043) mechanism. This R21 funding will be used to refine the design of dental clinic staff training, study implementation, and data collection procedures, to optimize the design of the definitive trial, and to test and document recruitment and data collection mechanisms.

The specific aims of this R21 proposal are:

1. To design and refine preconceived models of training format, study implementation, and intervention through focus groups with dentists and dental hygienists.
2. To define and refine study implementation, the referral process, recruitment, and data collection strategies and protocols through the sequential engagement of dental practices in active patient enrollment in a nonrandomized feasibility testing process.
3. To develop a working Manual of Procedures (MOP) for a future Phase III clinical trial.

The feasibility study will be conducted through private practice dental clinics surrounding the Mayo Clinic in Rochester, MN. We are planning for a multicenter Phase III clinical trial involving private practice dental clinics in the communities surrounding Rochester, MN, and Indianapolis, IN, in collaboration with the Indiana University Nicotine Dependence Program.

Eligibility Criteria:
Patients were eligible to participate if they were cigarette smokers, older than the age of 18 years, and presenting to the dentist for routine dental prophylaxis.
Sleep Apnea : Diagnosis and Monitoring

This prospective study aims to evaluate a new medical screening method to detect and discriminate sleep apnea-hypopnea events. A new device called ApneaBand will be tested to propose a new screening method facilitating the diagnosis and monitoring of the sleep apnea syndrom, still underdiagnosed. This device will be tested in comparison with polysomnography (PSG), the gold standard reference method of sleep apnea diagnosis.

The objective of this study is to dertermine the performance of the ApneaBand, a new non-intrusive and portable device, in detecting sleep apnea, in comparison with PSG.

40 apneic and non apneic subjects will wear the ApneaBand recording the different sleep stages and the occurency of apnea-hypopnea sleep events through four sensors including oximetry (oxygen saturation), photoplethysmography (pulse wave), electrodermal activity and tri-axial accelerometer (movements).

Inclusion visit will be proceeded at the University Hospital Grenoble-Alpes ; polysomnography and mesures by the ApneaBand will be proceeded at the patient's home by IC@dom. Patients will be equiped with PSG + ApneaBand during the first night and with ApneaBand only the second night.

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate or severe obstructive sleep apnea (OSA), diagnosed by polygraphy or PSG for less than 2 years, and not treated for that.
* Non apneic person (Berlin score = 0 or 1)
* Person be able to use the personal health monitoring device ApneaBand
* Be legally able to give consent
* Person affiliated to social security

Exclusion Criteria:

* Patient already treated for OSA
* Patient equipped with an electric medical device (non-exhaustive examples: cardiac pace maker, cochlear implant, neuro-stimulator)
* Being unable to understand and to follow recommendations for the study due to cognition or language problems
* Pregnant women, feeding and parturient
* Person under administrative or judicial control, or who is protected under the act
* Person in exclusion period for another study
* Person which would perceive more than 4500 euros of compensation because of its participation in other clinical studies in 12 months preceding this study
A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies or Lymphomas

This is a Phase 1, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, and DLTs to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD), and the RP2D of sequential doses of IBI363 (study drug) in subjects with advanced, refractory solid malignancies or lymphomas.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects, ≥ 18 years
2. Subjects with a documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic; subjects with documented lymphomas
3. Subjects with a malignancy (solid tumor or lymphoma) that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor
4. Subjects who are refractory to or intolerant to existing therapy(ies) known to provide clinical benefit Note: Subjects may have received and failed prior therapy with a PD-1/PD-L1 inhibitor and be considered eligible for this trial.
5. Subjects with measurable or non-measurable disease according to RECIST v1.1 or standard criteria for lymphoma (Lugano 2014)
6. Subjects, both male and female, who are either not of childbearing potential or who agree to use a highly effective method of contraception during the study beginning within 2 weeks prior to the first dose and continuing until 6 months after the last dose of study drug
7. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol

Exclusion Criteria:

1. Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug. Women of childbearing potential (WOCBP) or fertile men with WOCBP partner(s), not using and not willing to use a highly effective method of contraception.
2. Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
3. Subjects with:

   * Active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to first administration of study drug unless adequately treated and considered by the Investigator to be stable.
   * Active uncontrolled bleeding or a known bleeding diathesis.
A Study to Investigate Biomarkers of Skin Androgenization Following Testosterone Administration (0000-015)(COMPLETED).

Postmenopausal women will receive testosterone gel or matching placebo gel daily. Sebum excretion rates will be measured before and after 6 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 3 years postmenopausal
* Subject is in good general health
* Subject is willing to avoid excess alcohol or strenuous physical activity during the study

Exclusion Criteria:

* Subject has donated a unit of blood or has taken an investigational drug in another clinical trial in the last 4 weeks
* Subject is a regular user of any illicit drugs
* Subject drinks excessive amounts of coffee, tea or cola
* Subject has used an estrogen or progestogens hormone replacement therapy in the past 6 months
* Subject has a history of cancer
* Subject has acne
Promoting Smoking Cessation in the Correctional Institutions

The aim of this project is to promote and evaluate a smoking cessation intervention through the "Quit to Win" Contest organised in correctional institutions in Hong Kong.

The aim of this project is to promote and evaluate a smoking cessation intervention through the "Quit to Win" Contest organised in correctional institutions in Hong Kong. The specific objectives of the study are:

1. To test the effectiveness of face-to-face brief cessation advice and video education for smoking cessation among current smokers at the correctional institutions in Hong Kong;
2. To evaluate the process and outcome of the recruitment of smokers through qualitative interviews; and
3. To conduct qualitative interviews with quitters and non-quitters to examine their experience on the intervention.

Although smoking prevalence is decreasing in Hong Kong, there are still 615,000 daily cigarette smokers in Hong Kong in 2017 and half will be killed by smoking \[5\] which accounts for over 7,000 deaths per year. Smoking is a highly addictive behavior and it is difficult for smokers with strong nicotine dependence to quit without assistance. Despite the low smoking rate in the general population, smoking prevalence remain high in the correctional institutions. Incarcerated prisoners suffer disproportionately from mental illness, substance use disorders and disease infections. They are in need of health care such as treatment or prevention for smoking. There is a lack of evidence on the effectiveness of smoking cessation intervention in the correctional setting. More work is required to provide smoking cessation assistance to these high risk and underserved population.

The aim of this project is to promote and evaluate a smoking cessation intervention through the "Quit to Win" Contest organised in correctional institutions in Hong Kong. The specific objectives of the study are:

1. To test the effectiveness of face-to-face brief cessation advice and video education for smoking cessation among current smokers at the correctional institutions in Hong Kong;
2. To evaluate the process and outcome of the recruitment of smokers through qualitative interviews; and
3. To conduct qualitative interviews with quitters and non-quitters to examine their experience on the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong residents aged 18 or above
* Smoke at least 1 cigarette per day in the past 3 months
* Able to communicate in Cantonese (including reading Chinese)
* Exhaled carbon monoxide (CO) 4 ppm or above, assessed by a validated CO smokerlyzer
* Intent to quit / reduce smoking

Exclusion Criteria:

* Smokers who have difficulties (either physical or cognitive condition) to communicate
* Currently following other smoking cessation programs
Multicentric Registry of Patients With Acute Leukemia Infected by COVID-19

The COVID-19 epidemic (Coronavirus Disease 2019) currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). Epidemiologically, acute myeloblastic leukemias (AML) are the most common of acute leukemias. The incidence of acute lymphoblastic leukemia (ALL) is 900 new cases in France in 2018, of which 57% in humans. The treatments administered to AML and ALL patients induce variable immunosuppression: neutropenia, neuropathy, deficits in humoral or cellular immunity or combinations of these deficits. Patients with AML or ALL therefore represent a population at high risk of developing a serious form in the event of infection with SARS-CoV-2. To date, no data is available in the literature to assess the impact of the COVID-19 epidemic in the population of patients with acute leukemia.

The main objective of the study is to determine the clinical and biological prognostic factors during SARS-CoV-2 infection in patients with acute leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute leukemia according to WHO criteria 2016 ≤ 5 years
* Diagnosis of a proven or probable SARS-CoV-2 infection according to the following criteria:

  1. Proven infection: positive Polymerase Chain Reaction (PCR) regardless of the radio-clinical picture (other tests made available later and having good diagnostic performance will be accepted)
  2. Probable infection: negative PCR but association of

     1. Evocative clinical signs, of recent installation: fever, respiratory signs (cough, dyspnea, chest pain), body aches, sore throat, rhinorrhea, headache, diarrhea / abdominal pain, frank asthenia, loss of taste / smell, conjunctivitis, type of frostbite AND
     2. evocative radiological signs, on CT: diffuse or diffuse aspect of frosted glass, condensations including pseudo-nodular condensations, association of frosted glass and condensation within the same lesion, nodules and micronodules, thickening of the interlobular septa) or on chest radiography: interstitial, alveolo-interstitial or alveolar syndrome, single or bilateral AND
     3. absence of differential diagnosis

Exclusion Criteria:

* None
Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia (0991-042)

This is an open-label study of MK0991 in children between 3 to 24 months of age with new onset fever and neutropenia. The purpose of the study is to investigate plasma drug levels of caspofungin.


Eligibility Criteria:
Inclusion Criteria:

* Patient is 3 to 24 months of age with one or more of the following conditions:
* Leukemia, lymphoma, or other cancers
* Bone marrow or peripheral stem transplantation
* High dose chemotherapy leading to a decrease in white blood cells
* Aplastic anemia
* Patient has an absolute neutrophil count \<500 mm3 (a specific type of white blood cell that fights infection) AND at least one recording of fever \> 38 degreesC (oral or oral equivalent) within 72 hours of screening.

Exclusion Criteria:

* Patient is \<3 months or \>24 months of age at the time of study drug administration
* Patient has proven or probable invasive fungal infection at the time of enrollment
* Patient has certain blood clotting or liver function abnormalities
* Patient is hemodynamically unstable, exhibits hemodynamic compromise or is not expected to survive at least 5 days
* Patient is taking rifampin, cyclosporin A, phenytoin, carbamazepine, or phenobarbital.
Performance Evaluation of AirWay Medix Closed Suction System Compared With a Standard Closed Suction System

The aim of this prospective, randomized study is to compare the performance, safety, and ease of use (usability) between two closed suction systems, the AirWay Medix Closed Suction System and Kimberly KimVent while intubated with an endotracheal in hospitals and ICU. 26 adults with an endotracheal tube and mechanical ventilation will be randomized into 2 groups to receive one of the following closed suction systems endotracheal tubes:

1. AirWay Medix Closed Suction System
2. KimVent Turbo-Cleaning Closed Suction System Kimberly clarK The groups will be compared regarding the safety, performance and ease of use (usability).


Eligibility Criteria:
Inclusion Criteria:

1. Aged greater than 18 years
2. Mechanically ventilated for more than 6 hours
3. Endotracheal intubation anticipated to be routine (not difficult) based upon preoperative airway assessment
4. Signed informed consent
5. Sexually active female subjects of childbearing potential must be practicing adequate contraception during the treatment period -

Exclusion Criteria:

1. Gross / massive hemoptysis
2. Received lung transplantation in the past
3. Admitted from other hospital already mechanically ventilated
4. Previously received mechanical ventilation
5. Active bronchial bleeding
6. Pregnant women, women who plan to become pregnant and breastfeeding women.
7. Substance or alcohol abuse
8. Participation in concurrent trials
9. Any reasons making the patient a poor candidate in the opinion of the investigator -