cyrilzakka/clinical-trials huggingface dataset:
Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays

We hypothesize that intranasal steroid application will have a beneficial therapeutic effect in adults with regard to resolution of serous otitis media and/or negative middle ear pressure, as compared to placebo. We further hypothesize that the rate of spontaneous short-term resolution of otitis media wit effusion in adults treated with placebo will be relatively low (minority of patients).

Newer intranasal steroid preparations are generally safe with relatively few side effects as demonstrated in large studies dealing with allergic rhinitis.

Eustachian Tube Dysfunction (ETD) primarily refers to an absent or inadequate ability to open the eustachian tube. The term Serous Otitis Media (SOM) generally referring to an accumulation of fluid within the middle ear space, in absence of signs indicating acute infection. Commonly, this can result in a conductive hearing loss due to restriction of tympanic membrane mobility. Negative Middle Ear Pressure (NMEP) is often a precursor to the development of SOM, and has it's own effect on the acoustic properties of the middle ear, also resulting in conductive hearing loss.

Due to the lack of a single accepted medical intervention to deal with ETD and the general benign nature of this condition, it is common practice for some physicians to take a "wait and see" initial approach when this clinical entity is encountered in lieu of prescribing unproved medications. It is generally accepted that some patients with Negative Middle Ear Pressure (NMEP) and/or Serous Otitis Media (SOM) will undergo spontaneous resolution of symptoms, yet the exact resolution rates are not clearly defined.

The purpose of this double-blind, randomized study of either triamcinolone acetonide nasal spray or a sham placebo nasal spray for 6 weeks is to determine if there is improvement in a test of middle ear pressure. Neither the subjects nor the Investigator will know which of the two treatments is being used until the end of the study.

Resolution of ETD symptoms will be measured by changes in the tympanogram, a test to measure pressure within the middle ear. This measurement will be taken at baseline and after 6 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 0-18 years
* Patients with serous otitis media and/or negative middle ear pressure as documented by otoscopic examination and tympanometry will be considered for enrollment
* Pregnant

Exclusion Criteria:

* Unwilling to discontinue breast feeding, when applicable
* Active upper respiratory infection
* Nasopharyngeal mass
* Chronic infectious otitis media
* Cholesteatoma
* Acute infectious otitis media
* History of otologic surgery other than placement of a pressure equalizer tube in the affected ear
* History of radiation therapy to the head and neck region
* Neuromuscular disease
* Cystic fibrosis
* Immunodeficiency
* Mucociliary disorders
* Craniofacial disorders/syndromes
* Cleft palate
* Development delay and/or symptoms suggestive of perilymph fistula
Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose

The QuickClose study is a prospective, non-randomized study, to evaluate the safety and efficacy of the QuickClose device using two different dose types of heat exposure.

Patients undergoing a diagnostic angiogram procedure will be treated with the QuickClose device. Two groups of 20 patients each, will be enrolled consecutively, Group A will complete enrollment before enrollment into Group B begins. Patients will be monitored until 30 days after the procedure

The primary safety endpoint is the incidence of major complications related to method for achieving hemostasis at the puncture site. The secondary safety endpoint is the incidence of minor complications related to method for achieving hemostasis at the puncture site. The primary efficacy endpoint are time to hemostasis, time to ambulation and time to discharge . The secondary efficacy endpoints are device and procedure success.

Eligibility Criteria:
Inclusion Criteria:

1. The patient must be ≥ 18 years of age
2. The patient or guardian must provide written informed consent
3. The patient must be willing to comply with follow-up requirements
4. The patient has no child bearing potential or has a negative pregnancy test within the previous 7 days.
5. Patient is eligible for same day discharge

Procedural Inclusion:

1. A intravascular procedure was preformed using 6 Fr introducer
2. The introducer sheath is located in the common femoral artery

Exclusion Criteria:

1. Manual compression has been preformed on the ipsilateral arterial site within the previous 6 weeks
2. Any closure device has been used on the ipsilateral arterial site within the previous 180 days
3. Any reentry of the ipsilateral site is planned within the next 6 weeks.
4. History of surgical repair of blood vessels of the ipsilateral arterial site
5. Significant bleeding diathesis or platelet dysfunction

   1. Thrombocytopenia (Plt count ≤ 100,000)
   2. Anemia (Hgb ≤ 10mg/dl and/or Hct ≤ 30mg/dl)
6. Has life expectancy of less than 1 year due to terminal illness
7. Currently being treated for an infection
8. Receiving GP 2b/3a inhibitors or requires warfarin therapy within the last 14 days.
9. INR results \> 1.2 on day of procedure
10. Experienced a Myocardial infarction (CK-MB ≥ 2x upper limits of normal) within the previous 72 hours
11. Received thrombolytic within previous 72 hours
12. Patient is currently enrolled in an investigational device or drug study which endpoints have not been met.
13. Absent of pedal pulse
14. Pre-existing autoimmune disease (i.e., Lupus, Addison's Disease, Grave's Disease)
15. Has Body Mass Index(BMI) \<20, or BMI \>40
Intersession Processes in Psychotherapeutic Treatments Using an Ecological Momentary Assessment Approach (ISA-Bell)

The effects of a monitoring intervention as an add-on to face-to-face Cognitive Behavioral Therapy (CBT) for depression are assessed in this randomised trial. Monitoring consists of Ecological Momentary Assessment (EMA) of symptoms and inter-session processes via mobile phones. Twenty sessions of face-to-face CBT + EMA are compared to twenty sessions of face-to-face CBT (treatment as usual, TAU). 84 patients with mild to moderate depression will be randomised to CBT + EMA or to TAU.

As mobile technologies advance, healthcare is increasingly utilising mobile interventions to accompany traditional interventions such as psychotherapy. Mobile assessments of symptoms and other processes are also used as low-level interventions and are believed to lead to symptom improvements in patients with symptoms of depression, for example. However, robust evidence on the health benefits of monitoring interventions in patients with depression is lacking.

The investigators are interested in the potential benefits of a monitoring intervention as an add-on to face-to-face Cognitive Behavioral Therapy (CBT) for depression. Therefore, the investigators will conduct a randomised trial to investigate the effects of a monitoring intervention consisting of Ecological Momentary Assessment (EMA) of symptoms and inter-session processes via mobile phones. Twenty sessions of face-to-face CBT + EMA will be compared to twenty sessions of face-to-face CBT (treatment as usual, TAU). Participants in the CBT + EMA group will be asked to answer monitoring questions twice daily for two four-week blocks during the CBT treatment. A total of 84 participants with mild to moderate depression will be randomized. Of these, 48 participants will be randomized to CBT + EMA and 36 participants will be randomized to TAU. The primary outcome of interest is change in the Patient Health Questionnaire (PHQ-9) score at four-month follow-up assessment.

Throughout the study, there will be five assessment timepoints: Baseline (before the first therapy session), four weeks after the fourth therapy session, four weeks after the twelfth therapy session, after the last session (post-treatment) and the 4-month follow-up (four months after the last therapy session).

Eligibility Criteria:
Inclusion Criteria:

* ICD-10 diagnosis of mild or moderate depression, first or recurrent episode (F32.0, F32.1, F33.0, F33.1)
* PHQ-9 ≥ 5
* Possession of smartphone with internet access
* Signed informed consent

Exclusion Criteria:

* Acute or past suicidality; self-reported
* Acute addiction (F10 - F19)
* Dysthymia (F34.1), postpartum depression, or severe depression (F32.3; F33.3)
* PHQ-9 \> 20
* Depression not main mental health concern
* Planned onset or planned change in antidepressant medication
* History of psychotic symptoms, bipolar disorder, personality disorders, or organic brain disorders
* Cognitive impairment or physical disability that would hinder psychotherapy or the use of a smartphone
DSA Intragraft in Lung Transplantation: Diagnostic and Prognostic Value in Antibody Mediated Rejection

The diagnosis of AMR in lung transplant recipients is difficult and often comes too late, because of lack of standardized definition. The diagnosis is nowadays based on an expert multidisciplinary approach involving clinical, histopathological and immunological criteria.

Hypothesis: the presence of intragraft donor specific antibodies (gDSAs) could be used as a new diagnostic tool for AMR in lung transplant recipients Study Objectives: to evaluate, in lung transplant patients with circulating DSAs, the diagnostic value of gDSAs in AMR and to analyze its prognostic value on graft outcome.


Eligibility Criteria:
Inclusion criteria:

* Patient older than 18 years
* Transplanted pulmonary or cardiopulmonary patient
* And developing circulating anti-HLA antibodies directed against the graft or "DSA" at a threshold \> 1000 of MFI in the 30 days preceding the inclusion visit
* Affiliation to the French social security
* Patient able to understand the objectives and risks related to research and to give informed, dated and signed consent

Exclusion criteria:

* Patient whose anti-HLA antibodies are not directed against the graft (no DSA)
* Contraindication to performing a bronchial fibroscopy with transbronchial biopsies
* Treatment with intravenous immunoglobulin (less than 1 month before inclusion) or Rituximab (less than 6 months before inclusion)
* Plasma exchanges (less than 3 months before inclusion)
* Risk of bleeding predictable (crushing disorder, impossibility of stopping the offending treatments)
* Impossibility of giving the subject informed information
* Subject under the protection of justice Subject under guardianship or curatorship
* Pregnancy
* Breastfeeding
Mechanical Bone Stimulation and Adenosine 5'-Triphosphate (ATP) Release in Humans

Rationale: Mechanical loading is well-known to have a strong anabolic effect on bone. It has therefore been proposed that a mechanical intervention could be an effective non-pharmacological approach to treat bone loss associated with conditions such as osteopenia and osteoporosis. Data from in vitro experiments indicate that the purine nucleotide adenosine 5'-triphosphate (ATP) is released by bone cells and mediates cellular crosstalk via P2 purinergic receptors in response to mechanical stimulation. ATP release by bone cells may thus be part of a general mechanism by which mechanical loading ultimately results in increased bone formation, but this remains to be investigated in humans in vivo. The investigators hypothesize that a mechanical intervention in humans leads to a rise in systemic ATP concentrations due to ATP release from bone.

Objective: To investigate in vivo whether a measurable increase in systemic ATP levels occurs in response to mechanical stimulation of bone in humans.

Study design: Intervention study with a non-randomized, non-blinded design. All subjects will participate in a single experiment, lasting approximately 3 hours, during which the subjects will receive a mechanical intervention at a fixed dose.

Study population: Maximally 10 healthy human volunteers (18-35 y). Intervention: Subjects will receive a gentle and safe mechanical intervention, which will be administered by means of a Juvent 1000 Vibration Platform delivering low-magnitude mechanical stimuli (i.e. vibrations) to the forearm. The mechanical stimulation will be administered at a frequency of 90 Hz and amplitude of 10 µm in an intermittent fashion, i.e. three 10-minute periods of stimulation with 10-minute rest periods in between.

Main outcome parameters: As the primary outcome parameter, a change in extracellular ATP concentrations as a result of the mechanical intervention will be assessed systemically.


Eligibility Criteria:
Inclusion Criteria:

* Healthy human volunteers;
* Age 18-35 years;
* Cannulation of veins in forearm possible;
* Written informed consent.

Exclusion Criteria:

* Metabolic bone disease (osteoporosis, Paget's Disease, hyperparathyroidism, osteomalacia) or any other condition affecting bone metabolism (e.g. corticoid-treated rheumatoid arthritis);
* Recent bone fracture of any kind ≤ 12 months preceding the study;
* Blood donors.
Measuring the Balance Improvement on Multiple Sclerosis Patients After a Short Training Period With an APOS (All Phase Of Step Cycle) Kit

Randomised double blind study of two parallel groups,one of the groups trained with the full APOS kit (a shoe with an additional bio mechanical device)

The control group trained with the Apos shoe without the bio mechanical device. both groups will be checked at the beginning of the study, one month later and at the end of the study after two months. The tests include neurological test, functional test(FSST,up and go test and berg balance test) gate analysis and quality fo life (rays) test.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Multiple sclerosis Cerebellar impairment EDSS under 4.5 age 18-65 years signed informed consent form

Exclusion Criteria:

* pregnancy
* coronary event in last 6 month
* 30 days or less after acute attack
* steroidal treatment in the last 60 days
* alcohol abuse
Comparison of Laparoscopic and Open Inguinal Hernia Repair in Elderly Patients

Inguinal hernia is one of the most frequently performed surgeries in general surgery. This surgery can be performed with both open and laparoscopic techniques. There is no clear consensus on whether inguinal hernia repair, which is one of the most frequently performed surgeries in elderly patients, should be performed open or laparoscopic. The application of the open technique with regional anesthesia methods such as spinal anesthesia and local anesthesia makes these methods attractive. The fact that laparoscopic techniques cause patients to recover faster also makes these techniques attractive. However, the fact that it is usually performed under general anesthesia is a significant disadvantage. Increasing comorbidities and increased drug use, especially in elderly patients, make surgeons think about which technique to prefer. The aim of this study is to compare open and laparoscopic inguinal hernia repair, which should be preferred in patients over 65 years of age.


Eligibility Criteria:
Inclusion Criteria:

* Patients with inguinal hernias.
* Patients aged over 65.

Exclusion Criteria:

* Younger than 65 years.
* Incarcerated or strangulated inguinal hernias.
Use and Decision-making About Colorectal Cancer Screening Among Hispanic Men and Women

During this first year, the researchers have worked toward identifying factors influencing initiation of colorectal cancer screening among Hispanic men and women aged 50 and older and developing an intervention plan using Intervention Mapping, a framework for systematic health promotion program planning, implementation, and evaluation. The researchers are also currently in the preliminary stages of developing two promotora (lay health worker)-delivered interventions: a small media intervention (video, flip chart, pamphlets) and a tailored interactive multimedia intervention, prior to the actual collection of data. Thus, although 733 subjects have been approved by the Committee for the Protection of Human Subjects to be enrolled in this study in the future, no subjects have been enrolled at this time. Consequently, there have been no adverse events, and since the risks associated with participating in this study are negligible, the researchers do not anticipate any adverse events in the future. No modifications have been made to the research since the last review, other than that the researchers are currently reassessing the need to conduct preliminary qualitative research as proposed in the original protocol.

During this first year, the researchers have worked toward identifying factors influencing initiation of colorectal cancer screening among Hispanic men and women aged 50 and older and developing an intervention plan using Intervention Mapping, a framework for systematic health promotion program planning, implementation, and evaluation. The researchers are also currently in the preliminary stages of developing two promotora (lay health worker)-delivered interventions: a small media intervention (video, flip chart, pamphlets) and a tailored interactive multimedia intervention, prior to the actual collection of data. Thus, although 733 subjects have been approved by the Committee for the Protection of Human Subjects to be enrolled in this study in the future, no subjects have been enrolled at this time. Consequently, there have been no adverse events, and since the risks associated with participating in this study are negligible, the researchers do not anticipate any adverse events in the future. No modifications have been made to the research since the last review, other than that the researchers are currently reassessing the need to conduct preliminary qualitative research as proposed in the original protocol.

Eligibility Criteria:
Exclusion Criteria:

* Personal history of colorectal cancer
Risk Stratification in End Stage Renal Disease (ESRD) - ISAR Study

The purpose of this study is to evaluate the use of non-invasive markers of the autonomic function and micro- and macrocirculation to predict mortality and cardiovascular end points in end-stage renal disease patients. Furthermore we aim at getting new insight into the insufficiently understood pathophysiology leading to excessively high cardiovascular and non-cardiovascular mortality in dialysis patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. End-stage renal disease (ESRD) and receiving maintenance hemodialysis

Exclusion Criteria:

1. Any clinically significant infection.
2. pregnancy
3. history of malignant disease with a prognostic life expectancy less than 24 months
4. missing of written and informed consent
Nutritional Therapy on Underweight Critically Ill Patients: an Observational Study

Critically ill patients with body mass index (BMI) inferior to 20 kg/m2 have worse outcomes compared to normal and overweight patients. The impact nutrition therapy in this population is not yet stablished. There is a concern that too low caloric intake might worse their malnutrition; on the other hand, overfeeding is always a risk with serious consequences.

The hypothesis of this study is that nutritional support, especially caloric and protein intake, can influence the outcome of underweight critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Ages eligible for study: 18 years and older
* Gender eligible: both
* Nutrition therapy: enteral, parenteral feeding, nothing by mouth

Exclusion Criteria:

* Palliative care
* Exclusively oral nutrition
* Pregnancy
* Life expectancy inferior 24 hours
* ICU readmission
Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments

Patients with neovascular Age-related macular degeneration (AMD) and the particular feature of pigment epithelial detachments (PEDs) were not studied in the Phase III trials for ranibizumab (Lucentis). The PrONTO study was the first ranibizumab study to enroll such patients but only treated with ranibizumab until fluid within the layers of the retina was absent, not until the entire PED was absent. This study hypothesizes that there may be a difference in benefit between patients treated until just the retinal edema is gone and those in which the retinal edema and PED are both gone.


Eligibility Criteria:
Inclusion Criteria:

* Neovascular age-related macular degeneration patients over age 50
* Presence of a pigment epithelial detachment on optical coherence tomography
* Initial or recurrent disease
* Previous treatment allowed
* Visual acuity between Snellen 20/40 - 20/400

Exclusion Criteria:

* More than three previous treatments with PDT or other radiation/laser therapy
* Previous vitrectomy or other AMD surgical intervention
* Severe scarring or severe concurrent ocular disease (uncontrolled glaucoma)

Patients eligible for the study are randomized into one of two groups. Group 1 receives injections of ranibizumab until retinal edema is resolved. Group 2 receives ranibizumab injections until both retinal edema and the PED are resolved. Study duration is one year with visits once per month.
Multi-dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DDO-3055 Tablets in Healthy Subjects.

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multi-dose DDO-3055 tablets in healthy subjects for 7 days.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers aged 18-45 years;
2. Male weight≥50kg, female weight≥45kg, and 19kg/m2≤BMI≤26kg/m2;
3. Signed informed consent.

Exclusion Criteria:

1. Allergic constitution, suspected to be allergic to the study drug or any component in the study drug;
2. A value at screening is greater than the upper limit of reference range for the following clinical laboratory parameters: AST, ALT, Total bilirubin, direct bilirubin, indirect bilirubin ；
3. Subjects with a value at screening is greater than the upper limit of reference range for serum creatinine;
4. Subjects with a positive value of HBsAg、HCV-Ab、HIV-Ab、TPPA at screening；
5. Subjects with blood loss ≥400mL within 3 months before screening;
6. Subjects has participated in a clinical trial and has received an investigational product within 3 months prior to the first dosing day in the current study.
7. Participants who are unwilling to take contraception or male subjects who cannot guarantee not to donate sperm during the trial and within 30 days after the last dose; female subjects with fertility who did not use contraception for at least 14 days before dosing;
8. Patients who had a positive blood pregnancy test and were breastfeeding at the time of screening.
9. Smokers (average daily smoking 5 or more); Subjects who consumed more than 15 grams of alcohol per day within one week prior to the screening;
10. Drug abusers or drug urine screening positive;
11. The researchers judged that the subjects had medical conditions that affected the absorption, distribution, metabolism and excretion of drugs or reduced compliance.
Video Images About Decisions for Ethical Outcomes in the Emergency Department (VIDEO-ED)

A randomized controlled trial of a video decision aid in the Emergency Department Setting to improve advance care planning documentation.

A randomized controlled trial of a video decision aid in the Emergency Department setting shown to patients followed by a brief advance care planning discussion and then relay that discussion to the patient's primary care provider and/or admitting clinical team and look at rates of advance care planning documentation in the electronic health record over time. Primary outcome is advance care planning documentation in the EHR at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* anyone aged 65 and over or anyone aged over 50-64 with an indicator of serious illness

Exclusion Criteria:

* non english or spanish speakers those with a POLST legally blind medically non stable requiring ICU level care