cyrilzakka/clinical-trials huggingface dataset:
The Influence of Different Mood States and Emotions on the Physiologic, Metabolic, and Perceptual Responses to Feeding Before Exercise

Many athletes anecdotally report modifying their nutritional intake before competition in order to avoid gut problems, but no studies have evaluated whether emotional state impacts tolerance to pre-exercise feeding. Therefore, this study will use movie clips (stressful, horror, and funny/amusing) to induce different mood states and emotions, which will be followed by ingestion of food before endurance running on a treadmill. In addition, metabolic and physiologic responses to mood induction will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 55 years
2. Able to run for 30 min at a moderate-to-vigorous intensity without stopping
3. No diagnosis or signs/symptoms of cardiovascular disease (CVD) or metabolic disorders
4. Currently physically active (at least 3 days/week of exercise at a moderate or higher intensity)
5. No visual or hearing impairments interfering with ability to see and hear video clips
6. No allergies to ingredients in Boost drink

Exclusion Criteria:

1. Aged \<18 or \>55 years
2. Unable to run for 30 min at a moderate-to-vigorous intensity without stopping
3. A diagnosis or signs/symptoms of CVD or metabolic disorders
4. Currently physically inactive (\< 3 days/week of exercise at a moderate or higher intensity)
5. Visual or hearing impairments interfering with ability to see and hear video clips
6. Allergies to ingredients in Boost drink
The Cost of Obsessive-compulsive Disorder (OCD) in China

The purpose of this study is to estimate the cost of obsessive-compulsive disorder in China based on the prevalence rate from a social perspective.

Obsessive-compulsive disorder(OCD) is one of relatively common mental disorders with a prevalence of 1.63% in China. OCD usually begins in adolescence or young adulthood , it will become a chronic disabling disease, if it is not treated in timeand.OCD can be so severe that it can seriously impact on some or all areas of a person's life, bring huge economic burden. At present, there is only one article on the cost of OCD in the United States in the 1990s, and this part of the data in China is blank.A cross-sectional study recruited 600 patients with OCD from 13 hospitals in eastern, western, southern, and northern China. A structured questionnaire was used for face-to-face interviewing to collect costs related to OCD. The direct costs for each patient and indirect costs ffor each patient and their caregivers were calculated . The human capital method is used to calculate indirect costs. Through weighting, the cost of OCD in China is estimated from a social perspective using a bottom-up methodology.

Eligibility Criteria:
Inclusion Criteria:

* primarily diagnosed OCD meet DSM-5 critera
* 16-65 years old
* Get informed consent from patients

Exclusion Criteria:

* Concurrent neuropsychiatric diseases such as schizophrenia, which severely interfere with treatment costs
* Drug abuser
* Unable to understand the questionnaire
A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease (EPPIC-1)

1) To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD), on time to first occurrence of any event of the triple composite outcome of initiation of dialysis, kidney transplant or doubling of serum creatinine (sCr) when compared with placebo; 2) To evaluate the safety and tolerability of long-term AST-120 therapy in patients with CKD; 3) To evaluate the effects of AST-120 versus placebo, on other measures of renal function.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Moderate to severe CKD, not anticipated to require dialysis or renal transplant within the next 6 months
* Patient survival expected to be no less than one year
* Serum creatinine in men \>= 2.0 mg/dL (\>= 177 µmol/L) and \<= 5.0 mg/dL (\<= 442 µmol/L), and in women \>= 1.5 mg/dL (\>= 133 µmol/L) and \<= 5.0 mg/dL (\<= 442 µmol/L) at Screening
* Urinary total protein to urinary total creatinine ratio must be \>= 0.5 on a spot void at Screening
* Blood pressure \<= 160/90 mmHg at both Screening and Baseline. In addition, blood pressure, if measured, must have been stable in hypertensive patients over the 3 months prior to Screening, with no more than 1 blood pressure reading \> 160/90 mmHg
* In patients being treated for hypertension, they should be on a stable anti-hypertensive regimen

Exclusion Criteria:

* Obstructive or reversible cause of kidney disease
* Nephrotic syndrome defined as a ratio of urinary total protein to urinary creatinine of \> 6.0 as measured on a spot void
* Adult polycystic kidney disease
* History of previous kidney transplant
* History of recent (within the past 6 months) accelerated or malignant hypertension
* Uncontrolled arrhythmia or severe cardiac disease within the past 6 months
* History of malabsorption, inflammatory bowel disease, hiatal hernia, active peptic ulcer, or severe GI dysmotility, not attributable to the use of a phosphate binder
* Received any investigational agent or participated in a clinical study within the previous 3 months
* Presence of any significant medical condition that might create an undue risk with study participation, or significantly confound the collection of safety and efficacy data in this study
Genetic Newborn Screening for Rare Diseases Within the Screen4Care Project

The main objective of the genetic newborn screening part of the Screen4Care-project is to shorten the path to rare disease diagnosis and to facilitate early intervention. Therefore, genetic newborn screening for currently treatable rare diseases (TREAT-panel approach) will be offered to families expecting a baby. Whole genome sequencing (WGS) will be offered as additional diagnostic approach to newborns participating in Screen4Care TREAT-panel approach, if they develop symptoms suggestive of a genetic disease.

To evaluate to what extend genetic newborn screening has an impact on participating infants and their families, a follow-up with standardised questionnaires will be performed for all participating families.


Eligibility Criteria:
Inclusion Criteria:

* TREAT-panel:

  * newborns
  * Infants born in one of the participating hospitals and birth centres
  * Informed consent signed by both parents/legal guardian to participate in genetic newborn screening (TREAT-panel)
* Whole genome sequencing:

  * Participation in the TREAT-panel study
  * Symptoms suggestive of a genetic disease within the first 2 years of life
  * Informed consent signed by both parents/legal guardian to participate in genetic newborn screening (TREAT-panel) and the whole genome sequencing

Exclusion Criteria:

* Missing informed consent of parents/legal guardian
Lidocaine Mucilage-ICG as an Optical Agent for Tumor Delineation During Breast-conserving Surgery

Around 15%-30% of patients receiving breast-conserving surgery (BCS) for invasive breast carcinoma or ductal carcinoma in situ (DCIS) need a reoperation due to tumor-positive margins at final histopathology. Currently available modalities used for intraoperative surgical margin assessment all have specific limitations. In order to improve intraoperative tumor localization and surgical margin assessment in BCS, we developed a fluorescent tracer, the Lidocaine mucilage-ICG tracer, which could be locally injected and detected by fluorescent camera systems during operation. In this study, we aim to evaluate the efficacy of Lidocaine mucilage-ICG as an agent for intraoperative tumor delineation.


Eligibility Criteria:
Inclusion Criteria:

* Female at least 18 years old
* Histologically or cytologically confirmed breast carcinoma
* Patients planned to receive a breast-conserving surgery
* Patients received a preoperative breast magnetic resonance imaging
* Informed consent form understood and signed
* Patient agrees to all follow-up visits
* Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days of study entry
* Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the surgery

Exclusion Criteria:

* Psychiatric or other condition that may interfere with the study
* Known allergy or contraindication to any study drug
* Patients received neoadjuvant therapies
* Patients received an excision biopsy of the tumor
* Breast feeding period
* Pregnant (female of childbearing potential only)
Bronchoscopic Intrabullous Autologous Blood Instillation (BIABI) for Emphysema

Patients with large bullae (large empty air sacs in the lung) may benefit from bullectomy (surgery to resect these bullae), however this is a major surgery with significant potential morbidity and long hospital stays. Many patients are not well enough to have this surgery, or may not wish to have it. A less invasive means of attempting to shrink the size of the bullae is to directly inject the patients' own blood into the bullae (we believe that this can lead to an inflammatory reaction leading to gradual scarring and volume loss). This can be performed bronchoscopically in a 20-30 minute procedure using conscious sedation (avoiding general anaesthesia).

The aim of this study is to assess the effects on lung function, quality of life measures, functional measures and CT measured lung volumes of bronchoscopic intrabullous blood instillation in patients with bullous emphysema.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 35 years
* Large bulla on CT scan where bullectomy is contraindicated or is actively avoided.
* Hyperinflation - TLC ≥100% predicted, RV ≥150% predicted
* Exertional breathlessness (mMRC \>0)
* Optimum COPD treatment for at least 6 weeks
* No COPD exacerbation for at least 6 weeks
* Fewer than 3 admissions for infective exacerbations in the preceding 12 months
* Written informed consent

Exclusion Criteria:

* Inability to obtain informed consent
* Co-morbidities that would render bronchoscopy or sedation unsafe.
* Anaemia or other reasons precluding venesection.
* Clinically significant bronchiectasis
* Arrhythmia or cardiovascular disease that poses a risk during procedure
* Lung nodule requiring further investigation or treatment
* Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure
Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial

Phase IIa clinical trial, pilot, single centre, prospective, randomized, double-blind, placebo-controlled, with sequential inclusion of patients

20 Patients presenting with a moderate-severe acute ischemic stroke who will be randomized in a 1:1 proportion to intravenous treatment with allogeneic stem cells from adipose tissue or to placebo (vehicle).

Eligibility Criteria:
Inclusion criteria:

* Male or female acute ischemic patients aged 60-80 years with symptoms of acute cerebral infarction of less than 12h from stroke onset. If the time of symptom onset is unknown, it shall refer to the last time the patient was asymptomatic seen.
* Patients should be treated within two weeks from the onset of stroke symptoms.
* Patients with a measurable focal neurological that must persist to the time of treatment without clinically meaningful improvement.
* Patients must have computerized tomography (CT) and / or magnetic resonance imaging (MRI) compatible with the clinical diagnosis of acute ischemic stroke in the territory of the middle cerebral artery before being included in the study.
* Patients must have a score on the NIH Stroke Scale 8-20, with at least 2 of these points in Sections 5 and 6 (motor deficit) at the time of inclusion.
* Immediately (i.e. few minutes) before the stroke, patients should have a score on the mRS ≤ 1 (no symptoms at all or no significant disability despite symptoms, able to perform everyday tasks and activities).
* Women of childbearing age should have a negative pregnancy test performed prior to inclusion.
* Obtaining informed consent signed (after a detailed explanation of the nature and purpose of this study, the patient or guardian or legal representative must give their consent to participate by signing the informed consent document). Assent from a relative or career if the patient is unable to give meaningful consent (e.g. in cases of dysphasia, confusion, or reduced conscious level).

Exclusion criteria:

* Comatose patients. Patients with a score of 2 or more in the item 1a of the NIHSS related to the degree of awareness.
* Evidence on neuroimaging (CT or MRI) of brain tumour, cerebral oedema with midline shift and clinically significant compression of ventricles, cerebellar infarction or brainstem, or intraventricular, intracerebral or subarachnoid haemorrhage.
* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.· Active infectious disease, including HIV, hepatitis B, Hepatitis C, etc.
* Pre-existing dementia.
* Specify health status or any clinical conditions (e.g., life expectancy, co-existing disease) or other characteristics that precludes appropriate diagnosis, treatment or follow-up in the trial.
* Patients who are participating in another clinical trial.
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Patterns of Physical Activity and Sedentary Time in Survivors of a Critical Illness During a Hospital Admission

This study aims to describe the pattern of active and sedentary time in survivors of a critical illness, at three time points during their hospital admission (awakening in the ICU after ≥ 5 days of mechanical ventilation, discharge to ward and discharge from hospital).

The specific research objectives are to

1. Determine the duration of active and sedentary parameters including time and bouts in 24 hour periods
2. Examine changes in the active and sedentary parameters including time and bouts between time points of awakening and both ICU and hospital discharge.
3. Conduct a preliminary examination of relationships between activity and sedentary behaviour metrics with measures of muscle strength, physical function and hospital length of stay.

This is a prospective observational study that consecutively samples eligible patients with a critical illness, requiring intensive care. This study will use two activity monitors (accelerometers) to measure physical activity and sedentary variables from patients recovering from a critical illness in a single tertiary hospital on three occasions during their acute hospital admission. Accelerometer derived measures will be obtained from continuous 24 hour monitoring periods once patients are sufficiently awake and attentive within the ICU, at ICU discharge and again at acute hospital discharge. Measurements of patients muscle strength and physical function will also be made at the time of accelerometry.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient ≥ 18 years of age
* Patient is/was intubated (endotracheal, nasotracheal or tracheostomy) and required ≥ 5 days of mechanical ventilation (irrespective of reason for ventilatory support)

Exclusion Criteria:

* Unable to ambulate independently (either with or without gait aids) at least 10 meters within the last 3 months
* Ordinarily unable to understand written and spoken English sufficient to provide consent (e.g. due to non-English speaking background or pre-existing cognitive impairment)
* Assessed by medical staff as approaching imminent death or withdrawal of medical management
A Controlled Study of Quality of Life and it's Related Factors Among Gynecological Cancer Survivors

To compare quality of life and it's related factors between gynecological cancer survivor and healthy controls.

This study used a cross-sectional design. By using the method of purposive sampling, the 70 gynecological cancer patients who had completed the active treatments for six months will be recruited from the oncology and gynecology clinics of a medical center in the Northern Taiwan area. The 70 healthy controls without any cancer will be recruited from clinic and from friends and colleagues. The instruments include "Sample characteristics questionnaire," "Short Form-12 (SF-12)," "Medical Outcome Study Sleep Scale (MOS-sleep)," "Beck Depression Inventory-II (BDI)," "State-Trait Anxiety Inventory (STAI)," "Sexual Activity Questionnaire (SAQ), and "The Experiences in Close Relationships-Revised (ECR-R)." The data will be analyzed by descriptive statistical analysis, independent t-test, ANOVA, Scheffe's test, Pearson's correlation, and stepwise regression.

Eligibility Criteria:
Inclusion Criteria:

* Been diagnosed as cervical cancer, ovarian cancer or endometrial cancer, and has completed six months after the relevant treatment.
* 20-70 years old
* Agreed to participate in this study.

Exclusion Criteria:

* Combined with other non-gynecologic cancer (cervical cancer, ovarian cancer or endometrial cancer) patients.
Early Immune Responses to Inactivated Influenza Vaccine: a Pilot Study

Some people experience symptoms just after receiving the seasonal inactivated influenza vaccine. The cause of some of these symptoms is likely to be an immune response to the vaccine. The investigators would like to look at the earliest immune responses to the inactivated influenza vaccine. This pilot study will help us to determine at what time points we should look.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-50 years.
2. Good general health as a result of review of medical history and medications.
3. Willingness to participate in the study as evidenced by signing informed consent document.
4. Available for the duration of the trial.

Exclusion Criteria:

1. Known to be pregnant.
2. Medical, behavioral, cognitive or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol.
3. Severe allergy to eggs or any component of the influenza vaccine
4. Previous receipt of the 2011-2012 season influenza vaccine
5. Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the subject unable to comply with the protocol.
6. History of receiving any investigational product within the past 30 days.
7. Participant has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
8. History of a severe allergic reaction or anaphylaxis.
9. Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia.
10. Known immunodeficiency syndrome.
11. Use of chronic (≥14 days) oral or intravenous corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e. prednisone \>10 mg/ day) or immunosuppressive drugs within 30 days of starting this study.
12. Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study.
13. History of a surgical splenectomy.
14. Receipt of blood products within the past 6 months.
15. Refusal to allow storage of samples for future research.
A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model

To evaluate the efficacy of Bilastine Ophthalmic Solution (0.2%,0.4%,0.6%) compared to vehicle for the treatment of the signs and symptoms of allergic conjunctivitis


Eligibility Criteria:
Key Inclusion Criteria:

* be at least 18 years old
* be willing and able to avoid all disallowed medications and contact lenses
* must have a pregnancy test if of childbearing potential
* must be able to read an eye chart from 10 feet away

Key Exclusion Criteria:

* must not have any allergies to the study medications
* must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
* must not have used immunotherapy in the last 2 years
* must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial
Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss

This is a randomized, double-blind study of PIPE-505, or placebo, in subjects with hearing loss associated with speech-in-noise impairment.

This is a randomized-controlled, double-blind study of PIPE-505 or placebo given as an injection one time in subjects with sensorineural hearing loss associated with speech-in-noise difficulty. Visits to the clinic will occur at baseline, dosing, and days 1, 7, 14, 30, 60 and 90 after treatment. Safety will be assessed by periodic measurement of vital signs, ear examination, electrocardiogram (ECG), blood laboratory analyses and occurrence of adverse events (AE). Efficacy will be assessed by periodic audiometry and other audiological tests.

Eligibility Criteria:
Inclusion Criteria:

* Subject's primary language is English.
* Male or female between 18 and 75 years of age, inclusive, at randomization.
* Diagnosis of bilateral sensorineural hearing loss (SNHL).
* Normal tympanogram in the ear intended for injection (as defined in protocol) at Screening.
* Male or female subjects with reproductive potential agree to comply with protocol-approved double barrier contraceptive method during and for 3 months after study drug administration.
* The subject is in general good medical health with no clinically significant or relevant abnormalities, including medical history, physical exam, vital signs, ECG, and laboratory evaluations (hematology, chemistry, and urinalysis) as assessed by the Investigator.

Exclusion Criteria:

* History of chronic otitis externa or media, other chronic middle ear disorders, barotrauma, Meniere's disease, endolymphatic hydrops, perilymph fistula, herpes zoster oticus or other infectious etiology of hearing loss.
* Presence of a genetic, syndromal or developmental auditory disorder or of an autoimmune or serious neurological disorder that could contribute to auditory loss.
* Evidence of current conductive hearing loss, mixed hearing loss or otosclerosis.
* History of auditory loss related to exposure to known high-dose ototoxic drugs; any prior exposure to platinum-based medications.
* Otological disorders that would preclude safe tympanic injection.
* Presence of a cochlear implant.
* Evidence of bothersome tinnitus as determined by the Investigator.
* Intratympanic injection within 6 months of randomization.
* Use of an investigational product or intervention other than a non-interventional registry study (including vaccine studies) within the greater of 30 days or 5 half-lives (if known) prior to Screening or expected during the study.
* History of malignancy under current active treatment or considered at substantial risk for progression or recurrence during the study interval, as determined by the Investigator. Note, central nervous system neoplasms or head and neck cancer are excluded from eligibility regardless of treatment status.