cyrilzakka/clinical-trials huggingface dataset:
Changes in Brain Activity (Functional MRI Study) Before and After Behavioral Therapy of Height Phobia

We are interested in investigating the functional brain abnormalities of height phobia. Subjects will be have a functional MRI scan before and after a course of treatment with behavioral therapy.

The purpose of this study is to investigate the effects of in vivo exposure therapy on the functional brain activity of subjects with height phobia using a fear provocation paradigm. We expect differential activation of the fear circuitry in height phobics compared to non-phobic controls, and that successful behavioral therapy will normalize the heightened fear response in height phobia.

Eligibility Criteria:
Inclusion Criteria:

* Specific phobia of Heights

Exclusion Criteria:

* History of medical problems
A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN)

This is a randomized, double-blind, placebo-controlled, dose-ranging Phase 2 study to evaluate the efficacy and safety of CIN-107 as compared to placebo after 12 weeks of treatment in patients with treatment-resistant hypertension (rHTN).


Eligibility Criteria:
Inclusion Criteria:

* Is on a stable regimen of ≥ 3 antihypertensive agents (one of which is a diuretic) for at least 4 weeks prior to randomization;
* Be at least 70% compliant to their anti-hypertensive medication regimen;
* Has a seated BP ≥ 130/80 mmHg;
* Agrees to comply with the contraception and reproduction restrictions of the study; and
* Able to understand and willing to comply with all study visits, procedures, restrictions, and provide written informed consent according to institutional and regulatory guidelines.

Exclusion Criteria:

* Has a seated SBP ≥ 180 mmHg or DBP ≥ 110 mmHg;
* Has a body mass index (BMI) \> 40 kg/m2;
* Has an upper arm circumference \< 7 or \> 17 inches;
* Has been on night shifts at any time during the 4 weeks before Screening;
* Is using a beta blocker for any primary indication other than systemic hypertension (eg, migraine headache);
* Is not willing or not able to discontinue an MRA or a potassium sparing diuretic as part of an existing antihypertensive regimen;
* Is not willing or not able to discontinue taking a potassium supplement;
* Has documented estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73m2
* Has known and documented New York Heart Association stage III or IV chronic heart failure
* Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before Screening;
* Has known current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease diagnosed from a prior echocardiogram;
* Major cardiac surgery (eg, CABG, valve replacement), peripheral arterial bypass surgery, or PCI within 6 months before Screening;
* Has chronic permanent atrial fibrillation;
* Has uncontrolled diabetes with glycosylated hemoglobin \> 9.5% at Screening;
* Has planned dialysis or kidney transplant during the course of this study;
* Potassium \< 3.5 mEq/L;
* Potassium \> 5.0 mEq/L;
* Is positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen;
* Has typical consumption of ≥14 alcoholic drinks weekly.
A Pilot of a Personalized Circadian MHealth to Improve Sleep in Night Shift Workers

The goal of this project is to establish the evidence base for equitable accessibility and implementation of the precision sleep medicine mobile application, SHIFT.


Eligibility Criteria:
Inclusion Criteria:

* Inadequate sleep duration (habitual sleep less than 7 hours during the day)
* Willingness to download the SHIFT app and follow the lighting recommendations
* Ability to follow a set sleep schedule of 7 hours in bed after the night shifts
* Working at least 4 night shifts a month
* Shifts that must begin between 18:00 and 02:00 and last 8 to 12 hours
* Score of 8 or above on the Epworth Sleepiness scale and/or a score of 8 or above on the Insomnia Severity Index

Exclusion Criteria:

* Other independent sleep disorders (e.g., obstructive sleep apnea, narcolepsy, etc.)
* History of seizures or other significant neurological disorders
* Bipolar disorder
* Termination of shift schedule
* Pregnancy
* Current use of medications that impact sleep-wake functioning
* Alcohol and substance use disorder
Safe Colorectal Surgery in the Elderly

The objective was to evaluate the use and outcomes of robotic proctectomy compared to open and laparoscopic approaches for rectal cancer in the elderly. A retrospective cross-sectional cohort study utilizing the Nationwide Inpatient Sample (NIS; 2006-2013) was performed.

The objective was to evaluate the use and outcomes of robotic proctectomy compared to open and laparoscopic approaches for rectal cancer in the elderly. A retrospective cross-sectional cohort study utilizing the Nationwide Inpatient Sample (NIS; 2006-2013) was performed. All cases were restricted to age 70 years old or greater. The incidence of robotic proctectomy from 2006 - 2013 both as a whole as well as divided into approach was analyzed. Each approach was compared for both primary and secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 70 years of age or older
* underwent proctectomy

Exclusion Criteria:

* emergent admissions
* abdominoperineal resections
Safety and Efficacy of IQP-LH-101 in Postprandial Heartburn

This study is a randomized, placebo-controlled, single-blind, three-way crossover clinical trial to evaluate safety and efficacy of IQP-LH-101 (tablet form and liquid form) in postprandial heartburn.

The null hypothesis is that there is no difference between IQP-LH-101 and the placebo in terms of efficacy for postprandial heartburn treatment.


Eligibility Criteria:
Inclusion Criteria:

* Post-prandial heartburn (e.g. after a high-fat meal) in at least 2 months prior to the study (at least 2 times a week)
* Not receiving prescribed treatment for heartburn, reflux or upper gastrointestinal disorders
* Written informed consent is a prerequisite for subject enrollment.

Exclusion Criteria:

* Gastrointestinal bleeding within 12 months prior to the study
* Difficulty swallowing (dysphagia)
* History of or symptoms suggestive of Zollinger-Ellison syndrome, oesophageal or gastric malignancy, gastric or duodenal ulcer, pernicious anaemia, Barrett's oesophagus or systemic sclerosis
* Participation in other studies within the last 30 days prior to entry or during the study
First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r)

The purpose of this pivotal, first in man study will be to evaluate safety and efficacy of the novel, microcrystalline paclitaxel coated balloon (mcPCB, PAK, Balton) in the treatment of femoropopliteal artery disease.

Although clinically effective, the manufacturing process of first generation PCB coatings contributed to inconsistent drug concentrations, particulate formations on the balloon surface and their shedding during the interventional procedures. As a consequence developments of new PCB coatings have been proposed to address consistency, uniformity, small particle drug coverage, which may potentially contribute to improved vessel healing profile and improved clinical outcomes. Nevertheless, data on the safety and efficacy of this novel coating developments in the clinical setting remain limited. Previously in the experimental model, the investigators reported that delivery of paclitaxel via a novel mcPCB resulted in low long-term tissue retention of paclitaxel, however displayed reduced neointimal proliferation and favorable healing profile. Therefore in current clinical trial the investigators will address the feasibility and safety of the mcPCB (PAK, Balton) in the treatment of femoropopliteal restenotic disease in a prospective, randomized manner when compared to plain balloon angioplasty (PBA). The efficacy analysis will be observational and evaluated post-hoc, with no prespecified criteria.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 y.o.
* Claudication in Rutherford Class 1-5,
* Lesion in the femoropopliteal artery defined as \>50% and \< 99% diameter stenosis with length of up to 10 cm in vessel diameter of 3-7 mm
* Chronic total occlusions of length less than 100 mm
* Ability to cross the lesions with a guidewire.

Exclusion Criteria:

* Critical acute or chronic limb ischemia
* Acute coronary syndrome
* Chronic kidney disease stage III-V
* Restenotic lesion
* Femoropopliteal graft
* Known allergy to clopidogrel or aspirin
* History of stroke within past 6 months
* Age \> 80 y.o.
* Life expectancy \< 2 years
Post-marketing Surveillance (PMS) Study to Observe the Safety and Effectiveness of ARNUITY in Asthma Subjects in a Real World Setting

This is an open-label, multi-center, PMS study to observe the safety and effectiveness of ARNUITY administered in asthma subjects in a real world setting. This PMS shall observe how a broad range of subjects use the drug in the early stages after obtaining the approval. The objective of this PMS is to collect safety and effectiveness data on ARNUITY's approved label in a real world setting. Total of 600 subjects shall be recruited throughout the PMS period; 01 Sep, 2018 to 30 June 2020. ARNUITY is the registered trademark of GSK group of companies.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric subjects older than 12 years of age and adult subjects with asthma
* Subjects who will administer ARNUITY in accordance with the product information approved in Korea
* Subjects who have signed the informed consent form for the PMS

Exclusion Criteria:

* Subjects with status asthmaticus or subjects who have administered ARNUITY as primary therapy for other acute asthmatic episodes that require intensive treatment
* Subjects who have any known hyper-sensitivity to the drug or its ingredients
* Subjects who have severe hypersensitive reactions to milk proteins
* Subjects with hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
Effect of Ramosetron in Prevention of Intrathecal Morphine Induced Nausea and Vomiting

We would like to know the prophylactic anti-emetic effect of ramosetron compare to ondansetron in patient undergone total knee arthroplasty with spinal anesthesia and intrathecal morphine .

The patients were allocated into 2 groups by computerized block randomization according to a computer generated randomization. Treatment allocations were contained in sealed envelopes that were opened after patient enrollment. Patients received either 8 mg of intravenous (IV) ondansetron or 0.3 mg of IV ramosetron 10 minutes before spinal anesthesia and intrathecal morphine. All of the unilateral TKAs were done by one orthopedic surgeon using the same minimally invasive surgical technique and the same prosthesis.

Patients were monitored for incidence of Post Operative Nausea Vomiting(PONV) every 6 hours until 24 hours, and 24-48 hours postoperatively. Common adverse drug reactions associated with serotonin receptor antagonists (pruritus, dizziness, and headache) were also recorded.

The sample size calculation was based on the ability to detect a difference in incidence of postoperative nausea in between the two groups of 40% i.e. 50% in the ondansetron arm, and 30% in the ramosetron arm, consistent with a previous study. Using a power of 80% (β=0.2) and a two sided significance level(alpha) of 0.05, 45 patients in each group were required.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 50-80 years with a diagnosis of primary OA undergoing unilateral TKA
* American Society of Anesthesiologist (ASA) physical status I-III
* Giving written informed consent

Exclusion Criteria:

* Body mass index (BMI) \> 35 kg/m2
* Unable to undergo spinal anesthesia
* History of allergic to study drugs
* Impaired renal and/or hepatic function
* Use of systemic steroids and anti-emetics within 24 hours of operation
A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer

This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg intravenously (IV) on Day 1 of each 3-week cycle. The anticipated time on study treatment was until disease progression or unacceptable toxicity. The target sample size was \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Women \>=18 years of age
* HER2-negative metastatic breast cancer
* Previous adjuvant chemotherapy or hormonal treatment
* \>=1 measurable target lesion

Exclusion Criteria:

* Previous treatment with chemotherapy, an anti-angiogenic agent, or a biologic therapy for advanced or metastatic cancer
* Radiation therapy within 4 weeks of study treatment start or insufficient recovery from the effects of prior radiation therapy
* Central nervous system metastases
* Other malignancy within last 5 years, except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix
* Serious concurrent infection
The Comparison Between the Therapeutic Affect of Intravitreal Diclophenac and Triamcinolone in Persistent Uveitic Cystoids Macular Edema

Cystoids macular edema (CME) is one of the most common causes of low vision due to uveitis. The treatment for reducing the intra-ocular inflammation can decrease the macular edema. In some patients, CME persists even after inflammation control, and additional treatment is needed for better vision. Oral steroid, periocular and intravitreal Triamcinolone are the principles in treatment, but some complications like cataracts and increased ocular pressure have been seen. Diclophenac is a non-steroid anti-inflammatory drug that improves the vision and decreases the macular thickness by slowing down the prostaglandin E2 (PGE2) ending in vascular endothelial growth factor (VEGF) inhibition. In this study, the investigators are going to compare the therapeutic affect of intravitreal Diclophenac and Triamcinolone in persistent uveitic cystoids macular edema. Since diclophenac is a cheap and accessible drug in all curative centers it could be applied instead of Triamcinolone.


Eligibility Criteria:
Inclusion Criteria:

* cystoids macular edema which is diagnosed by OCT and flurocein angiography
* 5/200 \< Visual acuity \< 20/50
* resistance to routine treatment (oral treatment, periocular injection)

Exclusion Criteria:

* history of retinal disease cause macular edema like diabetes
* arterial occlusion
* monocular patients
* patients candidate for intra-ocular operation
* history of glaucoma or ocular hypertension
* any cataract that would interfere with OCT
Topic Insulin Accelerates Wound Healing in Diabetes

The purpose of this study is to determine whether topic insulin is effective to accelerates wound healing in diabetes patients

Wound healing is impaired in diabetes mellitus, but the mechanisms involved are not well established. The purpose of this study was to investigate the effect of a topic insulin cream on wound healing in diabetic patients. age eligible for study:18 years old-older gender eligible for study:both accepts healthy volunteers:no have a proband with T1DM or T2DM. A proband is an individual with more than one year of diagnosis.

have proband with a wound that is difficult to be healed for at least three months.

patients with serum creatinine \<1.5mg/dl Does not satisfy the above inclusion criteria infection diagnosed wound patients with cellulitis, venous stasis, inadequate perfusion, osteomyelitis and patient's inability to attend clinics for follow up

Eligibility Criteria:
Inclusion Criteria:

age eligible for study:18 years old-older gender eligible for study:both accepts healthy volunteers:no have a proband with T1DM or T2DM. A proband is an individual with more than one year of diagnosis. have proband with a wound that is difficult to be healed for at least three months.

patients with serum creatinine \<1.5mg/dl

Exclusion Criteria:

Does not satisfy the above inclusion criteria infection diagnosed wound patients with cellulitis, venous stasis, inadequate perfusion, osteomyelitis and patient's inability to attend clinics for follow up
Predictive Value of Copeptin in the Diagnosis of Acute Ischemic Stroke

In the USA, every year 795,000 patients suffer a cerebral vascular accident (CVA), which represents a yearly cost of $73.7 billion. CVA is the third main cause of death and the main source of acquired handicap in adults, as a result it is now a key priority in public health and part of " The CVA National Action Plan 2013-2014".

Copeptin is a polypeptide, by- product of Vasopressin metabolism. The increase of Copeptin plasma level, as for Vasopressin, is connected to hydric balance disorders found in cardio-vascular, renal and endocrine diseases. This link has already shown its interest in the early diagnosis of myocardial infarction and, in a more indirect way, CVA.

Copeptin is associated with acute endogenous stress. It seems to have interesting potential in the diagnosis of CVA by its negative predictive value like D-dimeres in pulmonary embolism. Proadrenomedullin and Brain Natriuretic Peptide (BNP) are both associated with the prognosis of cardio-vascular diseases and could be interesting in evaluating CVA prognosis.


Eligibility Criteria:
Inclusion Criteria:

* All patients, male or female, may be included if they meet the following criteria:
* patients with suspected ischemic CVA admitted in an acute stroke unit (thrombolysis unit).
* aged 18 and over.
* MRI Scan undertaken under the current protocol which includes the following sequences: distribution, T2\* (gradient echo), ARM, TOF and FLAIR.
* after information given the consent form is signed:

  * by the patient .or for those unable to express their consent (in case of coma or severe neurological disorder) by a relative or next of kin.

.the patient will be informed as soon as he has recovered his faculties in order to be able to express, if he wishes, his opposition to the pursuit of the research (sample destruction before tested).

- the patient must be registered with the Social Security

Exclusion Criteria:

All patients with a contraindication to MRI Scan:

* Pacemaker,
* Implanted cardiac defibrillator,
* Implanted Neuro-stimulator,
* Cochlear Implants
* Implanted Insulin pump
* Other implanted electronic medical device
* Vascular intracerebral Clip
* Cardiac Valve
* Other metallic implant
* Metallic foreign body
* Ventricular diversion valve
* Eye or hearing prosthesis
* Current or suspected pregnancy
* Breast feeding

Those who are under protection of justice, under guardianship or curatorship will also be excluded.
Lumacaftor/Ivacaftor Combination Therapy in Subjects With CF Who Have an A455E CFTR Mutation

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, crossover study that will evaluate the efficacy of LUM/IVA in subjects with CF 12 years of age and older who have at least one A455E mutation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female with confirmed diagnosis of CF
* All subjects must have an A455E mutation on at least 1 CFTR allele; no more than 10 subjects may have an F508del mutation on 1 CFTR allele.
* Forced expiratory volume in one second (FEV1) ≥30% of predicted and ≤90% of predicted at the Screening Visit, based on the Global Lung Function Initiative (GLI)-2012 multi ethnic all-age reference equations.
* Stable CF disease as judged by the investigator.
* Willing to remain on a stable medication regimen for CF from 4 weeks before Day 1 through the Follow up Visit.

Exclusion Criteria:

* History of any comorbidity reviewed at the Screening Visit that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
* A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation on at least one CFTR allele.
* Pregnant or breastfeeding.
* Any abnormal laboratory values at the Screening Visit.
* History of cataract/lens opacity, or evidence of cataract/lens opacity determined to be clinically significant by the ophthalmologist or optometrist during the ophthalmologic examination at the Screening Visit.
* Use of strong inhibitors or strong inducers of CYP3A, including consumption of certain herbal medications and certain fruit and fruit juices, within 14 days before Day 1
* Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements
Comparing PA Compliance During and After Decompensation in HFP

Pulmonary Artery Compliance measurements will be obtained with the Respirix device in patients with congestive heart failure decompensation. Echocardiogram, weight measurements, and BNP will also be gathered as independent measures of decompensation in the clinic. Pulmonary Artery Compliance measurements will be made daily during the hospital stay. Patients can continue using the device at home for the next 3 weeks. Each patient will serve as their own control and relative changes from their baseline will be recorded for each parameter.


Eligibility Criteria:
Inclusion Criteria:

1. Patient must ≥ 18 years of age
2. Patient has been diagnosed with Congestive Heart Failure, class II-IV
3. Patient is currently being admitted for decompensation related to Congestive Heart Failure
4. Subject or subject's legally authorized representative is able to give informed consent before entering the study.

Exclusion Criteria:

1. Currently pregnant or breastfeeding
2. Clinical signs or symptoms of a respiratory infection
3. Unable to obtain a high-quality signal, as determined by variability of nPAC values throughout a single breath, within 48 hours of enrollment
4. Inability to withstand a 10 second end-inspiratory pause, in the opinion of the investigator
5. Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination
Multiple Breath Washout (MBW) Using Sulfur Hexafluoride Reference Values and Influence of Anthropometric Parameters

Multiple breath washout (MBW) using Sulphur hexafluoride (SF6) has the potential to reveal ventilation heterogeneity in obstructive lung disease which is frequent in patients with small airway disease. However, it is missed by commonly used tests with reference data being scarce and mostly restricted to younger collectives. We aimed to evaluate the influence of anthropometric parameters on SF6-MBW reference values in pulmonary healthy adults.


Eligibility Criteria:
Inclusion Criteria:

non-smoker

* no history of pulmonary disease
* absence of dyspnoea, cough, thoracic pain
* no self-reported smoking history
* normal lung function testing

  * normal shape of flow-volume curve
  * normal shape of flow-pressure curve
  * FEV1/FVC \>70% (forced expiratory volume in 1 second / forced vital capacity)
  * TLC \> 80% of predicted (total lung capacity)
  * TLCO/VA \> 80% of predicted (transfer factor corrected for ventilated alveolar volume)
  * R5 \< 150% of predicted (resistance at 5Hz, impulse oscillometry)

smoker

- as above, but with self-reported smoking history \>10 pack years

Exclusion Criteria:

* unwilling or unable to give informed consent
* history of any respiratory disease