cyrilzakka/clinical-trials huggingface dataset:
Biomarker Discovery for Novel Drug Development in Idiopathic Pulmonary Fibrosis

Drug discovery can take many years especially since most studies to measure effectiveness depend on clinical outcomes like pulmonary function tests and hospitalizations.

This is an observational study designed to collect information, blood, and bronchoalveolar lavage fluid in people who have IPF and those who do not. The people who have IPF will be followed for 12 months to collect more biological samples and record clinically relevant information.

The goal of this study is to identify new molecular markers that are measurable and reliable in people who have IPF. It is hoped that these markers can be used in future drug studies to significantly speed up the process of finding drugs that help.


Eligibility Criteria:
Inclusion Criteria:

* age 35 to 80 years
* a diagnosis of IPF by consensus criteria

Exclusion Criteria:

* any condition that makes the patient at unacceptable risk for bronchoscopy
* the presence of significant co-existing emphysema on HRCT
* active cigarette smoking (defined as smoking within the last 6 months)
* the presence of a significant co-morbidity felt to limit life expectancy to less than 12 months.
* active listing for lung transplantation
* inability to provide informed consent
CRC Post-surgical Assessment and Recurrence Monitoring

The surgical therapeutic effect of stage II-IV CRC patients will be assessed by the plasma mSEPT9 assay, and patients will be followed up by the same assay for recurrence monitoring.

Assessment of surgical therapeutic effect of colorectal cancer (CRC) relies on computer tomography (CT) and serum CEA test. CT cannot be used frequently to monitor the instant change of lesions, while CEA cannot cover all patients due to its low sensitivity. The objective of this study is to assess the performance of the methylated SEPT9 (mSEPT9) in assessing the surgical therapeutic effect of CRC.

This study plans to recruit 50 CRC patients with stage II-IV CRC. Plasma samples before surgery, one day after surgery and seven days after surgery will be collected from each subject. mSEPT9 level will be measured at 3 months, 6 months, 9 months, 12 months, 18 months after surgery and relevant chemotherapy to monitor the possible recurrence of CRC. The mSEPT9 level will be measured by the Epi proColon 2.0 assay. The serum CEA will be measured parallel at the identical time points.

Primary outcomes include the plasma mSEPT9 levels before surgery, one and seven days after surgery.

Secondary outcomes include the serum CEA levels before surgery, one and seven days after surgery. It also includes the size of cancer for each patients, the ratio of patients with mSEPT9 complete response (CR), partial response(PR), progressive disease (PD) and stable disease (SD).

Eligibility Criteria:
Inclusion Criteria:

* stage II-IV CRC patients planning to perform surgery

Exclusion Criteria:

* stage 0-I CRC patients, patients with history of CRC or other cancers, patients not suitable for surgery, pregnant women, patients younger than 30 or older than 80.
Dose Linearity Study of Codeine Sulfate Under Fasted Conditions

The objective of this study was to examine the dose linearity of Roxane Laboratories' 15 mg, 30 mg, and 60 mg codeine sulfate tablets under fasted conditions


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Codeine Sulfate or any comparable or similar product.
Foley Catheter for Labor Induction in Women With Term and Near Term Membrane Rupture

In women undergoing labor induction for membrane rupture at or near term, we are investigating the addition of a foley catheter placed in the cervix to standard therapy (oxytocin administration) to decrease the time from the start of the induction to delivery.

To compare the efficacy of a transcervical Foley catheter with concurrent oxytocin administration compared to oxytocin infusion alone for cervical ripening and labor induction in women with premature rupture of membranes (PROM) at \> 34 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Preterm rupture of membranes (PROM) (Rupture of membranes = pooling/ferning/nitrazine +) Rupture of membranes (ROM) for ≥1 hour prior to starting induction
2. Cervix ≤ 2 centimeters (cm)
3. Gestational age ≥ 34 weeks by best obstetric estimate and clinical management decision is delivery
4. Singleton gestation
5. Cephalic
6. Vertex well applied to cervix

Exclusion Criteria:

1. Regular uterine contractions (contractions more frequent than every 5 minutes)
2. Two prior transverse uterine incisions/vertical uterine incision/ transmural myomectomy or any obstetric contraindication to labor
3. Evidence of chorioamnionitis (temperature of 100.4°F with uterine tenderness and maternal or fetal tachycardia or purulent discharge)
4. Lethal fetal anomalies
5. Intrauterine fetal demise (IUFD)
6. Previa
7. Suspected abruption/significant hemorrhage
8. Non-reassuring fetal heart rate (FHR) pattern
9. Non vertex fetal presentation
Effect of BI 1356 as Single Dose on the QT Interval in Healthy Female and Male Subjects

Assessment of the effect of BI 1356 or Placebo on prolongation of the QT interval


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females, 21 to 50 years of age
* Body mass index (BMI) ranging from 18.5 to 29.9 kg/m2
* Signed written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
* Participation in another trial with an investigational drug (≤ 60 days prior to administration or during the trial)
* Heavy smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
* Any deviation of a laboratory value that is considered to be of clinical relevance
* Excessive physical activities within the last week before the trial or during the trial
* Hypersensitivity to Moxifloxacin or related drugs of these classes
* Supine blood pressure at screening of systolic \< 100 mmHg and diastolic \< 60 mmHg
* Heart rate at screening of \> 80 bpm or \< 40 bpm
* Any screening ECG value outside of the reference range of clinical relevance including, but not limited to PR interval \> 220 ms, QRS interval \> 115 ms, QTcB or QTcF \> 450 ms, or QT (uncorrected) \> 470 ms
* Subjects involved in passenger transport or operation of dangerous machines

For Female subjects:

* Pregnancy or positive pregnancy test, or planning to become pregnant during the study or within 1 month of study completion Pregnancy
* No adequate contraception during the study and until 1 month of study completion, i.e. implants, injectables, combined oral contraceptives, IUD \[intrauterine device\], sexual abstinence (for at least 1 month prior to enrolment), vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who have not a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)
* Lactation period
The Effects of BAK on the Blood Aqueous Barrier of Pseudophakic Patients

BAK is one of the most frequent preservatives in eye drops. BAK is a quaternary ammonium salt with surfactant qualities. It can be bacteriostatic or bactericidal depending on the concentrations used. It has been shown to be effective against most bacteria with a few exceptions, such as Pseudomonas aeruginosa, or picornaviruses. It as been widely used in eyedrops, nose sprays, hand and face washes, mouthwashes, spermicidal creams, and in various other cleaners, sanitizers, and disinfectants. BAK gained popularity when it was first introduced because it also enhances corneal penetration of some drugs by causing epithelial separation.

It is present in several ophthalmic formulations, including most of the antiglaucoma medications. If used chronically, BAK has been found to cause ocular surface changes, such as dry eye and punctuate keratitis. BAK has also been suggested to promote a break in the blood aqueous barrier, which may lead to undesirable consequences, such as uveitis and cystoid macular edema. However, this information is controversial. The purpose of this study is to evaluate the consequences of BAK on the blood-retinal and blood-aqueous barriers of pseudophakic patients receiving BAK-preserved lubricating drops.

The primary hypothesis behind the study is that BAK may lead to a break in the blood-retina barrier in pseudophakic eyes, leading to an increase in macular thickness, compared to a non-BAK containing solution. The secondary hypothesis is that solutions containing BAK will increase the permeability of the blood aqueous barrier compared to non-BAK solutions. If the hypotheses are confirmed, they may serve as a contraindication to the use of BAK-preserved drops in pseudophakic eyes requiring chronic use of medications.

This is a prospective, randomized, examiner-masked, controlled study involving 44 pseudophakic eyes of 44 patients. Patients receiving any other eyedrop, with a previous history of uveitis, posterior capsule rupture or any other ophthalmic surgery will be excluded. Patients will be randomized to the use of a BAK-preserved lubricating drop or to the use of a non-preserved lubricating drop q.i.d for one month. Effects on the blood aqueous barrier will be objectively measured with a laser flare meter (Kowa, Japan) at baseline, 15 days and one month after inclusion. Patients will also have OCT images (Cirrus, Zeiss, USA) of the macula at the same time intervals to evaluate the possible effects on the blood-retina barrier. Macular thickness and the presence of cystoid macular edema will be evaluated at each time interval.

Eligibility Criteria:
Inclusion Criteria:

* Pseudophakic eyes that underwent cataract surgery at least 6 months before.

Exclusion Criteria:

* Use of any eyedrop.
* Other conditions associated with a break in the blood-aqueous or blood retina barrier (ie diabetes, ARMD, vasculitis, uveitis)
* Previous history of cystoid macular edema.
* Previous ocular surgery other than cataract surgery.
Magnesium Sulphate Neuroprotective Strategies for Preterm Deliveries

A Cochrane systematic review has confirmed that fetal exposure to magnesium sulphate given before preterm birth has a neuroprotective role. This review also showed a significant reduction in the rate of gross motor dysfunction in early childhood. Early Preterm birth (\< 34+0 weeks) and very low birthweight (\< 1,500 g) are the principal risk factors for cerebral palsy. Multiple pregnancy accounts for over 10% of preterm births and has a higher incidence of cerebral palsy than singleton pregnancy (twins have 7 times and triplets 47 times the risk of cerebral palsy compared with singletons).

Many of these patients come or get diagnosed as eminent preterm delivery very soon before the real delivery happens and are not able to complete the recommended therapy of loading and maintenance strategy for at least complete 4 hours before delivery.

Till now, there is a gap and lack of knowledge regarding the value of loading dose only as sufficient and effective strategy for neuroprotection compared to full therapy, which needs more health costs, longer monitoring and carries more risk for the patients.

Eligibility Criteria:
Inclusion Criteria:

1. Women at risk of preterm birth who are between 24+0 and 33+6 weeks of gestation.
2. When early preterm birth is planned or expected within 24 h, regardless of:

   * Plurality or parity
   * Reason for the risks of preterm birth
   * Anticipated mode of birth
   * Whether antenatal corticosteroids have been given or not

Exclusion Criteria:

* Women with known Hypersensitivity to magnesium
* Caution regarding dosage for patients with renal impairment
* Preterm delivery after 34 weeks
The Initial Assessment of Daily Insulin Dose in Newly Diagnosed Type 2 Diabetes

To investigate the daily dose of insulin in newly diagnosed Chinese type 2 diabetic patients who use the continuous subcutaneous insulin infusion (CSII) as the initial therapy.


Eligibility Criteria:
Inclusion Criteria:

All participants with type 2 diabetes, diagnosed by World Health Organization criteria, were recruited from outpatient of the Endocrinology Department in Shanghai Renji Hospital.

Exclusion Criteria:

Patients who had a history of coronary heart disease, abnormal renal function, active liver disease, chronic metabolic acidosis (including diabetic ketoacidosis), or severe chronic gastrointestinal disease.
Capillary Refill for Assessment of Dehydration

Capillary refill is used clinically to assess multiple things in children. This is a prospective observational study of the correlation between capillary refill time and degree of dehydration in children seen in a pediatric ED.

All patient presenting to the pediatric ER at OHSU less than 10 years are eligible to be enrolled if being seen for a condition putting them at risk for dehydration including emesis, diarrhea, etc. Children will have their capillary refill time measured and then sent home with a digital scale to track their weight. This will serve as the standard for calculating percent dehydration. When a patient has reached a stable weight at 1 week we will assume this is their healthy weight. There is no intervention in the study.

Eligibility Criteria:
Inclusion Criteria:

* All children with chief complaint of diarrhea, emesis, nausea, abdominal pain

Exclusion Criteria:

* Any child with chronic cardiac or pulm disease, raynauds syndrome, bilateral upper extremity trauma, previously enrolled in the study, already received IVF in the previous 48hrs, surgery within 1week, osteogenesis imperfecta.
Tele-based Psychological Emotional Support for Informal CARegivers of COVID-19 Patients in Intensive Care

The experience of a loved one's stay in a COVID-19 intensive care unit (ICU), either intubated or on respiratory support, forces family caregivers (hereafter 'caregivers') to face core existential fears, such as uncertainty and death. It also poses a serious threat to basic human needs for autonomy, competence, and relatedness, as family caregivers have no control over the illness, and limited prior competence in dealing with critical illness. COVID-19 likely aggravates this experience, as social distancing cuts caregivers off from visiting patients in the ICU, from using their usual social supportive network and the threat of infection extends to caregivers themselves, their children and family. Combined, these extreme circumstances put caregivers in emotional turmoil and in need of psychological support and assistance in managing difficult emotions. ICU caregivers are at risk of developing clinically relevant symptoms of anxiety or posttraumatic stress. During the patient's ICU stay, caregivers experience peri-traumatic distress, such as helplessness, grief, frustration and anger, that may predict later posttraumatic stress disorder (PTSD). Symptoms of anxiety and PTSD may last for months to years after the patient's discharge. Further, caregivers of patients who die in an ICU may be at greater risk of prolonged grief disorder. Supportive interventions may reduce psychological late effects in ICU caregivers, but the primary focus of the majority of interventions has been on communication or surrogate decision making. The CO-CarES study aims to develop and test the feasibility of a tele-delivered psychological intervention to enable caregivers of ICU patients with COVID-19 to better endure the overwhelming uncertainty and emotional strain and reduce the risk of posttraumatic stress and prolonged grief. The study hypothesizes that providing psychological intervention during and after the patients' hospitalization, can decrease peri-traumatic distress during ICU hospitalization and decrease risk of post-traumatic stress, anxiety, depression and perceived stress following discharge, as well as prolonged grief in bereavement. A secondary hypothesis is that changes in emotion regulation mediate effects of the intervention on long-term psychological outcomes.


Eligibility Criteria:
Inclusion Criteria:

* close relatives or friends of a patient hospitalized in an intensive care or intermediary care wards with COVID-19
* capable of completing online questionnaires
* speak Danish sufficiently for a therapeutic dialogue
* provide informed consent

Exclusion Criteria:

* suffering from a severe psychiatric disorder (such as schizophrenia) or in ongoing psychotherapeutic treatment for a psychiatric disorder (such as major depression generalized anxiety disorder or others), that cannot be paused
* unable to complete verbal phone- or videoconferencing calls
* unable to complete electronic questionnaires
Quality of Life and Device Acceptance in Patients With ICD Undergoing Remote ICD FU

This study investigates whether an additional remote follow-up of patients with implantable cardioverter-defibrillators (ICDs) has beneficial effects on Quality of life (QoL), levels of anxiety and depression and device acceptance. Patients are randomized to either conventional in-office FU only or additional remote surveillance, follow-up duration is 12 months. The influence of other variables (age, sex,..) is evaluated regarding their influence on study endpoints.

The rising number of implantable cardiac devices leads to an increasing amount of device-related workload, e.g. regular in-office follow-ups (FU). New means of ICD FU strategies are necessary to handle the increasing burden. ICD remote monitoring promises a time- and cost efficient alternative to conventional in-office FU strategies. Many studies have already shown benefits on FU burden reduction, on saving of costs and time, and recently on total mortality. The impact of remote ICD FU on Quality of life, anxiety and depression levels and device acceptance is still under discussion. The aim of this trial is to investigate the influence of additional remote ICD surveillance on the primary endpoint health related quality of life (HRQoL), further on levels of anxiety and depression and on device acceptance.

Eligibility Criteria:
Inclusion Criteria:

* Patients willing to participate
* Patients with new-implantation of an ICD or device replacement due to battery depletion between May 2011 and April 2013
* Sufficient knowledge of the German language
* Expectancy of life \>1 years at good clinical status
* Written informed consent

Exclusion Criteria:

* Age \<18 years
* Subjects not able to give written informed consent
* Subjects without sufficient German language skills
Paired Associative Stimulation in Methamphetamine Addiction

The investigators use paired associative stimulation (PAS) protocols to target cortico-cortical and cortico-subcortical networks to study cognitive deficits in methamphetamine addiction.

Paired associative stimulation (PAS) is a form of transcranial magnetic stimulation in which paired pulses can induce plasticity at cortical synapses, producing long-term potentiation (LTP) or long-term depression (LTD) effect. The investigators use paired associative stimulation (PAS) protocols to target cortico-cortical and cortico-subcortical networks (frontoparietal control pathway) by using different intervals between the paired pulses to explore the mechanism of cognitive deficits in methamphetamine addiction. The investigators hypothesize that different temporal sequences of cortical stimulation could produce facilitation or inhibition effect.

Eligibility Criteria:
Inclusion Criteria:

* In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
* Junior high school degree or above
* Normal vision and hearing
* Dextromanual

Exclusion Criteria:

* Have a disease that affect cognitive function such as history of head injury, cerebrovascular disease, epilepsy, etc
* Have cognitive-promoting drugs in the last 6 months
* Other substance abuse or dependence in recent five years (except nicotine)
* Mental impairment, Intelligence Quotient (IQ) \< 70
* Mental disorders
* Physical disease
Feasibility and Acceptability of a Single Session of Imagery Rescripting in a Community Sample of Adults

Negative experiences related to eating and appearance (NEREAs), such as critical commentary from parents about food, are common. They are also associated with depression and disordered eating, predictors of early mortality. Imagery rescripting (IR) is a therapeutic process during which individuals are guided through recalling distressing memories, like NEREAs, and generating ideas for bringing support into these memories. Single sessions of IR demonstrate promise in shifting the primary negative consequences of NEREAs in clinical samples of women. The current study examined the feasibility and acceptability of a remote-delivered, single session of IR in a community sample of men and women with NEREAs.


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old
2. endorse a history of at least one negative experience related to eating and/or appearance

Exclusion Criteria:

1. endorsed a current major medical condition;
2. met criteria for a full threshold psychiatric disorder (of moderate intensity when severity ratings are necessary, such as for substance use disorders and binge eating disorder);
3. were at high risk for suicide;
4. endorsed current or recent pregnancy or anticipated becoming pregnant within the next year;
5. were taking medication known to affect eating, weight and/or chronic disease risk;
6. were participating in eating, weight, or diabetes programming;
7. experienced weight loss \&gt; 10% in the past six months; and/or
8. could not complete study procedures in English.
Fluticasone Nasal Spray Patient Preference Study

The objectives of this study are to evaluate and compare patient preference for FF (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of allergic rhinitis following single-dose administration.


Eligibility Criteria:
Inclusion Criteria:

* allergic rhinitis
* literate

Exclusion Criteria:

* clinical significant uncontrolled disease
* Use of intranasal corticosteroids (\<4 weeks of FP \[branded or generic\],\<4 week exposure to FF, \<4 weeks use of other INS)
* Use of intranasal medications \<1 week
* Use of meds that significantly inhibit CYP4503A4
* Use of perfume or oral rinse on study day
* Allergy/intolerance to INS, antihistamines, or excipients
* Positive pregnancy test or female who is breastfeeding
* Affiliation with investigational site