cyrilzakka/clinical-trials huggingface dataset:
Exhaled Breath Condensate pH in Patients With Cough Caused by Gastroesophageal Reflux

Cough is the most common complaint for which patients seek medical attention in the United States, accounting for approximately 1 billion dollars in health care expenses annually. Gastroesophageal reflux disease (GERD) is the sole cause of chronic cough in up to 20-40% of all cases. The majority of these patients with GERD-induced cough have no classic "heartburn" symptoms, so this important cause of cough can thus be difficult to detect.

Our hypothesis is that changes in exhaled breath condensate (EBC) pH can be used as a sensitive and non-invasive marker to identify subjects with cough caused by acid reflux.

Gastroesophageal reflux disease (GERD) is the sole cause of chronic cough in up to 20-40% of all cases, and majority of these patients with GERD-induced cough have no classic "heartburn" symptoms. This important cause of cough can thus be difficult to detect. Non-invasive radiologic tests for GERD such as barium swallow is imperfectly sensitive in subjects with GERD-induced cough. The 24 hour pH probe, which continuously monitors esophageal pH and can correlate cough events with reflux events, is considered to be the gold standard test. However, this test is expensive, invasive, and not universally available.

The goal of the current study is to compare simultaneous measurements of esophageal pH with exhaled breath condensate pH after cough episodes, in patients with symptomatic cough. The cause of cough will be determined by a standard protocol, which includes 24 hour pH probe studies, and assessment for asthma, upper airway causes and sinus disease, and medication effects. All subjects will undergo 24 hour pH monitoring. During this monitoring period, they press an event button on the pH recording device to indicate a cough episode. After six such events, they will immediately perform an EBC collection, and EBC pH will subsequently be analyzed. Differences between pH changes in the group with cough cause by GERD will be compared to pH measurements in the group with cough but no GERD, to determine the sensitivity and specificity of pH changes for discriminating between the two groups, and optimal threshold values for pH changes in EBC.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* able to speak and read English
* chronic cough

Exclusion Criteria:

* Cigarette smoking within the past 6 months, or greater than 10 pack year history of prior smoking
* Any self-reported or clinically diagnosed form of active lung disease, including asthma and emphysema
* Symptoms of persistent rhinitis within the past three months
* Dysphagia
* Symptoms of acute viral upper respiratory tract infection or sinusitis within one month of entry into the study
* Pregnancy - based on self report
* Abnormal chest radiograph
Cell Free DNA for the Diagnosis and Treatment in Early NSCLC

The aim of the study is to evaluate whether peripheral circulating cell-free tumor DNA (cfDNA) can aid screening of recurrence after complete resection of early stage non-small cell lung cancer.

During evolution of primary tumor, tumor cells can be released into the bloodstream. It has also been shown that circulating cell-free tumor DNA (cfDNA) is released from apoptotic or necrotic tumor cells. In a study of cfDNA level after surgery in colon cancer patients, they suggested that cfDNA could detect recurrence of cancer several months earlier than the conventional follow up studies. Following several reports have suggested that cfDNA can invade host cells and alter host cell biology to cause cancer metastasis.

In this regard, we will collect from non-small cell lung cancer patients cohort who underwent curative resection, and will evaluate whether peripheral cfDNA can aid early detection of cancer recurrence. We will also study the genomic signature of cfDNA to assess the relationship between cfDNA and clinical outcome of non-small cell lung cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* All subjects need to sign the informed consent form
* All subjects have Non-small cell lung cancer which suspected on chest CT or confirmed pathologically preoperatively.
* Non-small cell lung cancer have to confirmed pathologically after operation
* Clinical stage I - IIIA by AJCC 7th staging system

Exclusion Criteria:

* Have been undergone chemotherapy or radiotherapy due to non-small call lung cancer
* Have been diagnosed any type of cancer other than cancer of skin, thyroid, uterine cervix with 3 years before enrollment
* Recurrent lung cancer
* Stage IIIB, IV by AJCC 7th staging system
Post-traumatic Stress Disorder After Pediatric Intensive Care Unit Hospitalization

The elements that promote the development of post-traumatic stress in parents following hospitalization in pediatric resuscitation and thus the options for improving initial care at the time of hospitalization are unknown.

It is therefore important to describe the prevalence of post-traumatic stress disorder with current pediatric resuscitation management data, but also to possibly describe the factors associated with it in order to optimize initial management.


Eligibility Criteria:
Inclusion Criteria:

- All parents of children aged 0 to 18 who have been admitted in paediatric resuscitation unit.

Exclusion Criteria:

* Holders of parental authority who cannot answer the questionnaire because they do not speak French.
* Opposition of one of the two holders of parental authority
* Minor parental authority holders
* Holders of parental authority under safeguarding of justice or guardianship
Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer

Generally, French studies concerned with the quality of life of cancer patients focus on the period of treatment (up to 2 years post diagnosis). However, studies about quality of life "after" cancer are relatively rare (= long-term quality of life, or from 5 years post diagnosis). These studies mainly concern the most common cancers (breast and prostate).

Or changes in quality of life after treatment could be different depending on the type of cancer. In addition, there is a significant influence of sociodemographic variables on the quality of life in remission.

Similarly using remote diagnostics, quality of life questionnaires related to health, must be reassessed because too often developed for situations in process.

Based on these findings, "ELCCA II" study proposes to study for five years, the evolution of the impacts of two types of cancer (breast and melanoma) on quality of life (overall and related to the subjective health), socioeconomic status, and behavioral and emotional dimensions (post-traumatic development, coping, anxiety-depression) of those treated.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of cancer (breast or melanoma) since less than 1 month
* no metastasis
* Inform Consent Form signed

Exclusion Criteria:

* severe psychiatric disorder (depression, psychosis, etc.)
* addictive pathology
* longtime antidepressant treatment (\> 3 months)
* Patient pregnant or breastfeeding
Evaluation of a New Treatment for Migraine Attacks

The purpose of this study is to evaluate the efficacy of a novel therapy for treatment of migraine, pain reduction and relief of associated symptoms during ongoing migraine attacks, and presence of a preventive effect post treatment.


Eligibility Criteria:
Inclusion Criteria:

* Female or male subjects, in otherwise good health, 20 to 55 years of age
* Subjects who meet the ICHD-2 (2nd Edition of The International Headache Classification) criteria for migraine headache
* Subjects with a minimum of 1 migraine attack per month
* Attack duration of 4 to 72 hours
* Normal attack intensity of at least 4 on a 0-10 VAS-scale

Exclusion Criteria:

* Completed heart surgery
* Cardiovascular disease
* Vascular damage on neck vessels
* Disease other than migraine of the CSN
* Severe disease of vital body organs
* Severe psychiatric disorders
* More than 6 migraine attacks per month
Combination Therapy Prevents the Relapse of RA

This trial aims to compare the cost effective and effect of preventing recurrence by different treatment of TFP and HCQ combined SSZ for remittent RA.

patients were divided into 3groups: Group A:TFP+MTX (week0-week60) Group B:TFP+MTX+HCQ+SSZ(week0-week12) and then MTX+HCQ+SSZ(week13-week60) Group C:TFP+MTX (week0-week12) and then MTX (week13-week60)

Eligibility Criteria:
Inclusion Criteria:

* Fulfill 2010 EULAR/ACR RA dignose criteria
* Age18-70 years old
* Have been teated regularly for 3 months
* Disease duration \> 6months
* DAS28\>3.2

Exclusion Criteria:

* Received surgical operation in 8 weeks
* Received other biological agent (eg. rituximab, anti-TNF agents, anti-IL6 agents)in 6 months;
* Injection of steroid in 4 weeks
* Coexisting with other CTD except for SS
* With severe and not controled cardiac vescular disease, neurological disease, pulmonary disease (including COPD and ILD), renal disease, liver disease, endocrine disease and Gastric Intestinal Disease
* With not controled diseases including asthma, IBD and psoriasis needing oral or injection of steroid
* Active infection with T\>38℃. Patients need admitted into hospital or biotics injection in 4 weeks or need oral biotics in 2 weeks
* Malignant history.
* Serum creatinine \>130 µmol/L
* AST/ALT higher than 2 times upper level
* platelet count\<100 x 109/L，or white blood count\<3 x 109/L
* Interstitail lung disease: Chest X Ray
* Hands X Ray ACR radiology staging shows IV stage RA
* Pregnancy or planing to pregnant in 2 years or suckling period women.
Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.

This trial is conducted in Asia, Europe and North America. The aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with Haemophilia B.


Eligibility Criteria:
Inclusion Criteria:

* Male patients with moderately severe or severe congenital haemophilia B with a Factor IX activity level below or equal to 2% according to medical records
* Age below or equal to 12 years (until patient turns 13 years, at time of inclusion)
* Body weight above or equal to 10 kg
* History of at least 50 exposure days (EDs) to other FIX products
* The patient and/or parent(s)/caregiver are capable of assessing a bleeding episode, keeping an electronic diary (eDiary), capable of conducting home treatment and otherwise able to follow trial procedures

Exclusion Criteria:

* Known history of FIX inhibitors
* Current FIX inhibitors above or equal to 0.6 Bethesda Units (BU)
* Congenital or acquired coagulation disorder other than haemophilia B
* Platelet count below 50,000/mcL at screening
* Alanine aminotransferase (ALT) above 3 times the upper limit of normal reference ranges at screening
* Creatinine level above or equal to 1.5 times above the upper normal limit of normal reference ranges at screening
* Human immunodeficiency virus (HIV) positive, defined by medical records, and with a CD4+ lymphocyte count below or equal to 200/mcL
* Immune modulating or chemotherapeutic medication (except single pulse treatment, inhaled and topical steroids)
* Previous arterial thrombotic events (myocardial infarction and intracranial thrombosis, as defined by medical records)
Azithromycin for Patients With Chronic Rhinosinusitis Failing Medical and Surgical Therapy

Justification: Chronic rhinosinusitis (CRS) is one of the most common inflammatory diseases with an incidence and prevalence superior to 10%. Unfortunately, more than 30% of patients do not respond to standard medical and surgical treatment, thus continuously increasing the symptomatologic and socio-economic burden of this disease.

Hypothesis: The investigators believe that the addition of azithromycin (AZI) to the treatment regimen of patients with refractory CRS failing conventional medico-surgical treatment will be beneficial in a symptomatologic and endoscopic level.

Primary objective: 1- To evaluate whether Azithromycine 250 mg PO three times weekly is effective in controlling signs and symptoms of CRS in high-risk patients unresponsive to standard management after endoscopic sinus surgery (ESS) with budesonide irrigations.

Secondary objectives:

i) Validate a simple and concise treatment algorithm for patients refractory to standard CRS treatment of ESS and BUDI, with the addition of low-dose AZI.

ii) Characterise and define the population deemed "high-risk" for standard CRS treatment failure by evaluating: 1) demographics, 2) inflammatory states and 3) the nasal flora microbiome of patients at the different follow-up points of this study.

iii) Explore the mechanisms of AZI by assessing the changes in inflammatory states and the nasal flora microbiome associated with successful AZI therapy.

Methods: Inclusion of all patients admitted for endoscopic sinus surgery (ESS) for CRS operated by the same surgeon (MD). Following their first postoperative visit (2 weeks), all patients will receive nasal irrigations with budesonide (BUDI) twice daily for 4 months and will be re-evaluated. If there is a failure of treatment, patients eligible to receive AZI will be randomized in to two groups, AZI 250mg or a placebo three times a week for 4 months. At every follow-up, complete endoscopic exams will be performed, along with sinus cultures and brush cytology.

Population: All patients deemed "high-risk" with CRS admitted for ESS between October 2014 and October 2015.


Eligibility Criteria:
Inclusion Criteria:

Patients with ≥1 of the following criteria:

* history of sinus surgery,
* first sinus surgery at ≤38 years of age,
* an absolute eosinophilia of ≥500 cells/mm,
* serum IgE levels of \>150 kIU/L,
* a Gram negative bacteria in a sinus culture,
* the presence of intra-operative eosinophilic mucin.

Exclusion Criteria:

* Patients with cystic fibrosis, inverted papillomas, osteomata, mucoceles or other lesions of the base of skull will be excluded.
* Patients with an elevated cardiovascular disease risk will be excluded from the randomized clinical trial part of this study.
Immediate Effects of Two Spinal Manipulative Techniques

The aim of this study is to investigate the instant effects of direct vertabral manipulation and indirect vertebral manipulation techniques on muscles mechanical properties, pressure-pain threshold and joint range of motion in individuals with chronic low back pain. Another purpose of this study was to compare the effects of both treatment methods on the parameters studied.

Resolving chronic low back pain is a costly obstacle. There is a wide spectrum of treatment for chronic low back pain, such as exercise training, pain training and spinal manipulation.It is the recommended spinal manipulation in the short and long term in chronic low back pain. Clinical Spinal manipulation is one of the most preferred methods of reducing pain and disability.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 ages
* Individuals with non-specific chronic low back pain who have continued pain for at least 3 months
* According to VAS, individuals with pain of at least 3 severity

Exclusion Criteria:

* Pregnancy situation or suspicion
* Spinal Stenosis
* Vertebral fracture
* Cancer
* Osteoporosis
* Individuals with BMI over 30 kg/m2
* Those with neurological disease that leads to November loss of muscle strength or spasticity-rigidity
Prostaglandin Metabolite in Urine Samples From Patients With Ovarian Cancer

RATIONALE: Measuring the amount of prostaglandin metabolite in urine samples and studying tissue samples in the laboratory from patients with ovarian cancer may help doctors identify and learn more about biomarkers related to ovarian cancer and may help the study of cancer in the future.

PURPOSE: This laboratory study is measuring the amount of prostaglandin metabolite in urine samples from patients with ovarian cancer.

OBJECTIVES:

* Determine the level of prostaglandin E_2 metabolite (PGE-M) in 24-hour urine samples collected prior to surgery or chemotherapy from patients with ovarian cancer.
* Determine cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) expression by western blot and immunohistochemistry (IHC) in ovarian tumor tissue samples and matched normal ovarian tissue samples, if available, from these patients.
* Correlate urine PGE-M levels with corresponding tissue COX-1 and COX-2 levels in urine and tissue samples from these patients.

OUTLINE: This is a pilot study.

Patients submit 24-hour urine specimens prior to surgery for evaluation of urinary levels of prostaglandin E_2 metabolite (PGE-M).

Patients also undergo assessment of tissue obtained at the time of surgery, including ovarian tumor tissue, normal surface ovarian epithelium tissue (if available), and fixed tissue embedded in a paraffin block. Tissue samples are analyzed by western blot and IHC for cyclooxygenase-1 and cyclooxygenase-2 expression.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of known or suspected ovarian cancer
* Age greater than 17 years

Exclusion Criteria:

* Pregnant or nursing
* Taking steroids or non-steroidal anti-inflammatory drugs (NSAIDs) on a regular basis.

PRIOR CONCURRENT THERAPY:

* No concurrent chronic use of steroids or NSAIDs
Non-invasive Repetitive Paraorbital Alternating Current Stimulation Therapy for Aphasia

The investigators assess if repetitive, transcranial alternating current stimulation (rtACS) can improve the speaking quality of the aphasic patient as well as other communication skills as naming, repeating and understanding spoken words, reading and writing. Further, it will be assessed if memory and attentiveness deficiencies after 10 days of therapy with brain stimulation are stabilized and remain stable after a training-free period of 60 days.


Eligibility Criteria:
Inclusion Criteria:

* stroke
* lesion age at least 6 months
* aphasia with at least moderate severity according to Aachener Aphasia Test (AAT)
* age between 40 and 75
* German-speaking (at a native speaking level)

Exclusion Criteria:

* cognitive or speech-language therapy during the 2-weeks stimulation course
* intensive language training when exceeding 1 hour, 2 times a week during the 2-weeks stimulation course and the follow-up period (60 days after stimulation was completed)
* additional neurological diseases, e.g. surgical brain tumor removal, untreated tumor disease, acute traumatic brain injury, and/or craniotomy
* (severe) dysarthria
* untreated hypertension exceeding 160/100 mmHg (patients with treated hypertension and blood pressure below 160/100 mmHg can be included)
* increased risk of vascular thrombosis
* epilepsy, photo sensitivity, acute focal findings (patients without focal findings or epileptiform discharges can be included when they had only a single seizure more than 10 years ago)
* dementias and neurodegenerative diseases
* significant psychiatric disturbances, e.g. schizophrenia
* major attention and/or memory deficits
* major hearing loss
* patients with uncorrected visual deficits
* severe global aphasia
* modality-specific disorders (pure speech apraxia, pure alexia, pure agraphia)
* electric or electronic implants (e.g. heart pacemakers)
* metal artefacts located at the head
* medication with impact on the central nervous system (e.g. antidepressant or sedative drugs)
* participation in another trial
* pregnant or breastfeeding women
A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Midazolam in the Blood

The main objective of this trial is to investigate the induction effect of multiple doses of BI 1015550 on the pharmacokinetics of the sensitive CYP3A4 substrate midazolam.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Further exclusion criteria apply
Intraoperative Phenylephrine Infusion to Reduce Postoperative Shivering in Lower Segment Caesarean Section

Assessment of whether and how phenylephrine infusion reduces postoperative shivering in spinal anaesthesia.

This study aims to evaluate whether phenylephrine infusion can reduce postoperative shivering among patients scheduled for elective lower segment caesarean section under spinal anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* More than 18 years of age
* American Society of Anesthesiologists (ASA) II patients
* Patients with singleton pregnancy who are scheduled to undergo elective lower segment caesarean section under spinal anaesthesia

Exclusion Criteria:

* Patients with contraindication to phenylephrine
* Patients with evidence of fever or infection, or hypothermia preoperatively
* BMI ≥ 40
* Height \<150cm
Relative Bioavailability, Transdermally Administered EE and GSD, 3 Applications Sites

Influence of different application sites on the blood levels after administration of a fertility control patch


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects
* Age 18-45 years
* Body mass index (BMI) 18-30kg/m²
* At least 3 months since delivery, abortion, or lactation before the first screening examination
* Ability to understand and follow study-related instructions
* Willingness to accept the synchronizing cycle and to use non-hormonal methods of contraception after starting the synchronizing cycle and during the treatment periods

Exclusion Criteria:

* Contra-indications for use of combined (estrogen/progestin) contraceptives (e.g. history of venous/arterial disease, liver disorders, migraine)
* Skin diseases with suspected alteration of dermal resorption and /or increased risk for dermal intolerance
* Regular use of medicines other than contraceptives
* Smokers (at the age of 31 to 45 years)
* Clinically relevant findings (e.g. blood pressure, physical and gynecological examination, laboratory examination)