cyrilzakka/clinical-trials huggingface dataset:
Studies of Hereditary Hemorrhagic Telangiectasia

OBJECTIVES: I. Examine screening modalities for pulmonary vascular arteriovenous malformation (PAVM) in individuals with endoglin mutations.

II. Examine the prevalence of cerebral arteriovenous malformations (CAVM) in individuals with hereditary hemorrhagic telangiectasia (HHT).

III. Investigate whether modifier genes exist that determine which individuals with HHT due to an endoglin mutation develop PAVMs and which develop CAVMs.

IV. Investigate the frequency of cardiac valve abnormalities in individuals affected with HHT due to an endoglin mutations.

PROTOCOL OUTLINE: Patients with hereditary hemorrhagic telangiectasia (HHT) undergo 5 different screening methods to determine which method is most effective in detecting arteriovenous malformations (AVM). Patients may participate in more than one screening method.

In part 1, patients undergo 3 different screening techniques (e.g., pulse oximetry, spiral computed tomography (CT), and contrast echocardiography) to detect pulmonary arteriovenous malformations (PAVM).

Patients in part 2 undergo magnetic resonance imaging (MRI) using gadolinium as the contrasting agent for AVM in the brain, known as cerebral arteriovenous malformations (CAVM). For pregnant women, this procedure may only take place if there is clinical evidence that suggests CAVM.

In part 3, Doppler ultrasound is used to screen for hepatic arteriovenous malformations (HAVM). The abdomen of each patient is viewed to detect AVM in the liver.

Patients in part 4 undergo echocardiograms as the screening method used to determine common heart valve abnormalities.

In part 5, blood samples are drawn from patients and analyzed to locate modifier genes as a possibility in determining severity of HHT.

Eligibility Criteria:
* Osler-Rendu-Weber disease (or hereditary hemorrhagic telangiectasia)
Socially Assistive Robots to Enhance Magnification Device Use for Reading

The aims of this exploratory research project are to customize, deploy and evaluate the preliminary efficacy of a socially assistive robot as a novel approach to motivate and encourage optimal, long-term use of new magnification devices for reading in individuals with vision loss. The goals are to promote patient acceptance, adherence and skills reinforcement to achieve proficiency in the use of the magnifier, in order to attempt to reduce visual disability while performing important daily activities, such as reading tasks. This is a high priority given the increasing prevalence of low vision, paucity of low vision rehabilitation providers, and barriers related to access to care, such as transportation and geography, all of which motivate the development of this complementary approach for the provision of additional support at home by the socially assistive robot.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with any level of vision loss due to any ocular disease,
* age 18 and older,
* received a magnification device(s) (i.e., hand-held optical magnifiers, portable electronic video magnifiers, some stand magnifiers and CCTVs) from the UCLA Vision Rehabilitation Center.

Exclusion Criteria:

* schedules not permitting participation in planned study sessions or visits (including planning to move or take extended vacation during study period),
* inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (cognitive impairment as per TICS),
* substance abuse,
* significant hearing loss (unable to hear communication by phone or from robot),
* significant medical condition likely to limit participation or lifespan,
* their magnifier device has features that would not work in conjunction with the beacon sensors: (1) hands-free and do not have a place where the patient's hand is holding the device during use (therefore, they would not register a significant change in temperature), and/or (2) no surface area of at least 1"x1" to which the beacon sensor could be attached without interfering with the device.
Fluoxetine in Pulmonary Arterial Hypertension (PAH) Trial

This protocol describes an open-label phase 2 clinical trial of fluoxetine in PAH looking at change in pulmonary vascular resistance (PVR) as the primary endpoint.

In this open-label clinical trial, 18 patients with pulmonary arterial hypertension will be given fluoxetine for 24 weeks. A Right Heart Catheterization will be performed at baseline and 24 weeks. Change in PVR will be the primary endpoint; other hemodynamic endpoints, quality of life, QIDS-SR depression scale, functional class and six-minute walk distance will also be evaluated.

Primary Hypothesis: Fluoxetine treatment for 24 weeks will lead to significantly lower pulmonary vascular resistance in 18 patients with PAH in patients treated in an open-label clinical trial.


Eligibility Criteria:
Inclusion Criteria:

1. WHO Group I PAH subtypes of idiopathic PAH and PAH associated with drugs / toxins, connective tissue disease, repaired congenital heart disease and unrepaired atrial septal defect
2. Age 16-80
3. WHO Functional Class II or III
4. Right Heart Catheterization within 3 weeks of study entry with mPAP ≥ 25 mmHg, wedge ≤ 15 mmHg, and PVR ≥ 3 Wood units.
5. Contraception use, (-) urine pregnancy test, not breast feeding (women of childbearing potential)
6. One or more approved PAH therapies for ≥ 3 months, no change in dose for 1 month (endothelin-1 antagonist, phosphodiesterase-5 inhibitor, prostacyclin / prostacyclin analog). Novel approved therapies in one of the three existing classes will also be acceptable as background therapy if they become available during the course of the study; other medication classes are excluded

   Exclusion Criteria:
7. WHO Functional Class IV or listed for lung transplant
8. Moderate or greater obstructive lung disease: FEV1/FVC \<70% and FEV1 \<60%
9. Moderate or greater restrictive lung disease: TLC or FVC \<60% (if 50-60%: OK if TLC or FVC ≥50% + PFT stable x1 year + CT with no more than mild lung disease)
10. Other cause for pulmonary hypertension: all other WHO group I diseases (including but not limited to liver disease, HIV), and WHO Groups II-V (i.e. left heart disease, lung disease, chronic PE and miscellaneous causes)24.

    1. High probability VQ or positive CTA
    2. Left ventricular ejection fraction \<40%
11. Depression
12. Severe liver, renal or other medical or physical disease preventing completion of the study procedures
13. Use of antidepressants within 3 months
Prospective Study on the Clinical Prognosis of Bilateral Central Lymph Node Dissection in the Patients With Unilateral Thyroid Papillary Carcinoma

This study recruit the patients with unilateral papillary thyroid cancer before operation,the patients agree to enter the test,and divided into experimental and control group.experimental group patients receive the surgery including unilateral thyroid lobectomy and bilateral central lymph node dissection.and control group receive the surgery including unilateral thyroid lobectomy and unilateral central lymph node dissection.last the investigators compare numbers of patient with tumor recurrence and metastasis rate of 5 years,numbers of metastatic lymph node,and numbers of participants with adverse events related to treatment between two groups in order to evaluate the significance of bilateral lymph node dissection.


Eligibility Criteria:
according by thyroid carcinoma TNM(tumor,lymph node, metastasis) staging of NCCN (National Comprehensive Cancer Network)

Inclusion Criteria:

* 1.Unilateral thyroid papillary carcinoma 2.TNM staging: T1\~2N0M0

Exclusion Criteria:

* 1.Bilateral thyroid papillary carcinoma 2.isthmus thyroid carcinoma 3.TNM staging: T3orT4 4.Clinic N1orM1
Hypofractionated Radiotherapy for Lung Cancer

The purpose of this trial is to pilot reducing the duration of radiation treatment for lung cancer patients from 6 to 5 weeks using tomotherapy. Specific patient doses will be based on tumor volume being treated. Modeling has shown that increased biologically effective dose (BED) to tumors can be achieved by shortening the radiation delivery schedule and increasing the dose per fraction. This requires decreasing the total dose to hold lung toxicity constant at each dose per fraction level. This is a major paradigm shift in the treatment in this disease and is projected to result in significant improvements in patient outcome as well as a substantial cost savings.


Eligibility Criteria:
Inclusion Criteria:

* Thoracic neoplasm requiring at lest 60 Gy conventional radiotherapy

Exclusion Criteria:

* Prior bleomycin or gemcitabine chemotherapy
* Prior thoracic radiotherapy
Combination of Chest Scanography and Nasal Viral Detection Test to Detect COVID-19 Positive Patients Before Surgical Intervention in a University Hospital During Coronavirus Pandemia

This research aims to improve the screening for COVID-19 upon admission to the Montpellier University Hospital for an act under general anesthesia or at high risk of transmission of the virus. Indeed, routine nasal swabs present many false negatives (60 to 70%) and many patients with the coronavirus have little or no symptoms. Performing a chest CT scan can reveal early signs very suggestive of viral pneumoniae due to the new coronavirus without additional risk compared to a simple chest X-ray (no injection of contrast medium, low exposure).

The objective is to assess the sensitivity of the diagnosis of COVID-19 by carrying out a nasopharyngeal RT-PCR and a low dose thoracic scanography at the hospital admission of patients scheduled to a procedure under general anesthesia or at risk of aerosolization (surgery, endoscopy, procedures involving risk of interventional radiology) in order to limit the risks of transmission to healthcare professionals or other patients and to rationalize the use of protective equipment.

This is an observational research without modification of care in the setting of COVID-19 pandemia. All clinical and biological data will be issued from routine care and medical charts. Routine use of CT scan and nasal swabs is an institutional approved strategy. Serologic tests will be performed as soon as available from serum collection collected after routine blood analysis. All data will be anonymously recorded after information and non-opposition of the patient.


Eligibility Criteria:
Inclusion criteria:

* Scheduled or unscheduled surgical or interventional procedure with at least one night in hospital
* Chest CT-scan within the first 24 hours
* Nasopharyngeal swaps within 24 hours before or after hospital admission

Exclusion criteria :

* Age under 18 years
* Patient with restriction of freedom
* Vital surgical emergency
* Direct admission to the COVID dedicated hospital
* Opposition to data utilization
Effects of Lipids on Gastric Emptying, Satiety Hormones, and Appetite in Severe Overweight

In lean subjects, free fatty acid (FFA) promotes gut hormone release, delays gastric emptying, and reduces appetite and energy intake more than an isocaloric load of triglyceride (TG). In obesity, the gastrointestinal sensitivity to food components may be reduced. In this study, the investigators compare the effects of the FFA oleic acid and the TG olive oil on gut hormone secretion, gastric emptying, appetite sensation, and subsequent energy intake in lean and severely obese subjects.

Nutritional lipid within the lumen of small intestine causes a range of physiological responses that suppress appetite and reduce energy intake. Thus, intestinal fat promotes the release of gastrointestinal hormones such as cholecystokinin (CCK), peptide-YY (PYY) and glucagon-like peptide-1 (GLP-1) that modulate gastrointestinal motility and are important for appetite regulation and food consumption.

The effect of ingested fat on gut hormone secretion is highly dependent on the lipolysis of triglycerides (TGs) into free fatty acids (FFAs). It has been demonstrated that adding a lipase inhibitor (tetrahydrolipstatin) to a pure fat meal accelerates gastric emptying and reduces CCK release. Furthermore, administration of tetrahydrolipstatin with an intraduodenal infusion of TG attenuates gastric relaxation and antro-pyloro-duodenal motility and reduces the release of CCK, PYY, and GLP-1 compared to TG alone. Finally, intragastric administration of FFA delays gastric emptying and augments the release of CCK and PYY compared to an isocaloric administration of TG. Hence, the presence of FFAs more than TGs within the small intestine seem to play a pivotal role in the regulation of appetite and energy intake.

Whereas acute intake of FFA represents a potent stimulus for suppression of appetite and energy intake, epidemiological evidence relates long-term high dietary fat intake with obesity and it is known that obese individuals prefer food with high fat content. The mechanisms behind this paradox remain unclear. However, sustained high fat-diet may change gastromotor responses and gut hormonal release to a dietary load of lipids. Moreover intraduodenal sensitivity to FFA (oleic acid) was recently reported to be reduced in obese subjects. The reduced appetite and energy intake after FFAs compared to TGs may, therefore, not apply to obese subjects.

The aims of this study are to evaluate gastric emptying, gut hormone secretion, appetite sensation, and energy intake after isocaloric gastric administration of FFA (oleic acid) and TG (olive oil) in lean and severely obese subjects.

Eligibility Criteria:
Inclusion Criteria:

* Lean subjects: BMI 20-25
* Severely obese subjects: BMI \> 50

Exclusion Criteria:

-Gastrointestinal symptoms
The Effects of Different Oral Hygiene Instructions

The aim of this study is to evaluate the effects of verbal and video-based oral hygiene instructions on the oral health parameters in patients of different age groups. 202 patients in 6-9 and 10-12 aged (n=101 and n=101, respectively) were included in the study protocol. Before oral hygiene instructions, baseline oral g of all patients were determined using Simplified Oral Hygiene Index (OHI-S). Within each age group, approximately half of the participants randomly assigned to verbal (n=50 for 6-9 ages, n=51 for 10-12 ages) and video-based OHI (n=51 for 6-9 ages, n=50 for 10-12 ages). Patients were re-called for after 30 days and final OHI-S scores were recorded.

In pediatric dentistry, preventive dental approaches are essential in providing sustainable oral health of children. Despite all the preventive applications, dental caries is still an important public health problem affecting preschool and school children. Oral hygiene education has an important role on the dental health services. This aims to increase awareness of oral health, provide information about it and encourage individuals to maintain oral health. Based on, the current study aims to evaluate the effects of verbal and video-based oral hygiene instructions on the oral health parameters in patients of different age groups. 202 patients in 6-9 and 10-12 aged (n=101 and n=101, respectively) were included in the study protocol. Before oral hygiene instructions, baseline oral g of all patients were determined using Simplified Oral Hygiene Index (OHI-S). Within each age group, approximately half of the participants randomly assigned to verbal (n=50 for 6-9 ages, n=51 for 10-12 ages) and video-based OHI (n=51 for 6-9 ages, n=50 for 10-12 ages). Patients were re-called for after 30 days and final OHI-S scores were recorded. Data were analysed with Shapiro-Wilk, Mann-Whitney U and Wilcoxon Signed Rank tests. Statistical significance level was considered as 5%.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6-9 years or 10-12 years
* Children who were medically free of chronic/systemic conditions
* Patients without physical or mental disabilities or syndromes
* Patients without motor dysfunction diseases
* Patients whose permanent central incisor and permanent first molar teeth had erupted and had not been extracted for any reason

Exclusion Criteria:

* Children aged \<6 or \>12 years
* Children with chronic/systemic conditions
* Patients with physical or mental disabilities or syndromes
* Patients with motor dysfunction diseases
* Patients whose permanent central incisor and permanent first molar teeth had not erupted
68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery

This phase 2-3 trial studies the utility of 68-gallium (68Ga)-prostate-specific membrane antigen 11 (PSMA-11) positron emission tomography/magnetic resonance imaging (PET/MRI) to find tumors in patients with prostate cancer who are undergoing resection surgery for prostate cancer that is prognostically expected to spread quickly (intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures, such as PET/MRI, may help find and diagnose prostate cancer, and reveal out how far the disease has spread. Radioactive drugs, such as 68Ga-PSMA-11, may bind to tumor cells that have specific receptors, and may allow doctors to see smaller tumors than the standard of care contrast-enhanced computed tomography (CT) or MRI scan.

OBJECTIVES:

1. To evaluate 68Ga-PSMA-11 PET/MRI for detection of tumor metastases in patients with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection.
2. To assess sensitivity (positive predictive value) and specificity (negative predictive value) of 68Ga-PSMA-11 PET/MRI for the detection of regional nodal metastases compared to pathology at radical prostatectomy.

OUTLINE:

Participants will receive 68Ga-PSMA-11 intravenously (IV). Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.

After completion of study, patients are followed up at 24 to 48 hours.

Eligibility Criteria:
INCLUSION CRITERIA

* Biopsy-proven prostate adenocarcinoma
* Planned prostatectomy with lymph node dissection
* Intermediate- to high-risk disease (as determined by elevated prostate-specific antigen (PSA) \[PSA \> 10\], T stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors)
* Karnofsky performance status of ≥ 50 \[or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent\]
* Diagnostic CT or MRI performed within 90 days of the research PET
* Able to provide written consent

ExCLUSION CRITERIA

* Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
* Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy, including focal ablation techniques (HiFu)
* Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery
* Metallic implants (contraindicated for MRI)
Comparison of Esophageal Manometry and CT Scan Measurements

The goal of this study is to determine the relationship between esophageal pressure (Pes) and superimposed pressure (SP) in subjects with morbid obesity.

In the clinical setting, Pes is a surrogate for pleural pressure, while SP is measured by means of chest CT scan images. The SP highly approximates the vertical pleural pressure gradient both in normal lungs and injured lungs in lean subjects. It is known that in the healthy obese patient the Pes is higher than that in normal lean patients, but there is no information about the relationship between high Pes with the SP in subjects with morbid obesity.

The investigators hypothesized that factors other than superimposed pressure determine the high Pes in subjects with morbid obesity. Hence, Pes should be high despite the low SP found in healthy obese individuals.

The investigators will test this hypothesis in a prospective observational cohort study.

In 12 subjects (6 with body mass index \> 40kg/m2, and 6 with body mass index \< 30kg/m2 ) with scheduled chest CT scan for clinical purposes:

1. The Pes will be measured during spontaneous breathing (baseline values at end-expiration and variations during tidal breathing). To achieve this purpose, an esophageal balloon (AVEATM Ventilator Esophageal Pressure Monitoring Tube Set, 8 FR, CareFusion, Yorba Linda, CA, USA) will be inserted after administration of local anesthesia (lidocaine spray 2%).
2. The SP will be determined by lung computed tomography imaging and the pleural pressure will be calculated in non-dependent lung regions as the difference between Pes and SP. For this purpose, an additional low-dose CT scan at the end-expiration will be taken after the scheduled CT scan.

During the research procedure, the Pes during the whole respiratory cycle, the CT image at the end-expiration, demographics, past and current medical history will be recorded.

There will be no follow-up phase in this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to take a chest CT scan for the clinical purpose at MGH Radiology Department
* 6 adult subjects with BMI more than 40kg/m2
* 6 adult subjects with BMI less than 30kg/m2
* More than 18 years old

Exclusion Criteria:

* Presence of pneumothorax
* History of spontaneous pneumothorax
* Severe coagulopathy (INR ≥ 4)
* Severe thrombocytopenia (Platelets count ≤ 5,000/mm3)
* Usage of any devices with electric current generation such as pacemakers or internal cardiac defibrillator
* Recent esophageal trauma or surgery
* Other esophageal diseases, such as esophageal cancer, leak, varices, and hernia
* Presence of hypoxemia, short of breath and dysphagia.
* Presence or suspicion of pneumonia or lung fibrosis.
Magnetic Resonance Imaging in the Diagnosis of Pulmonary Hypertension

The aim of the present study is to identify changes in the cardiovascular system in patients with pulmonary hypertension (PH) by magnetic resonance imaging (MRI). MRI is accepted as golden standard method for the evaluation of left and right ventricular morphology and function.

All patients who showed elevated pulmonary pressure in the right heart catheter investigation are assigned to MRI. Parameters derived from MRI are included in the clinical and therapeutic decisions. Well established as well as new MRI parameters are evaluated and compared to the results of right heart catheter. Further age-matched controls without known cardiac or pulmonary disease are investigated by native MRI.

Patients with suspected, latent and manifest PH and controls are investigated by MRI according to the following protocol in breathhold or free breathing (depending on the patients' breath-hold abilities). In case of elevated Creatinin values, no contrast agent is applied.

* Planning of cardiac views: Planning of 2-chamber view, short axes view and 4-chamber view.
* Morphological overview: Transversal and coronal Haste images
* Left and right heart functional and valve evaluation: Cine 2-chamber imaging, Multi-slice cine 4-chamber imaging, Cine Left and Right ventricular outflow tract imaging and Multi-slice cine short axes imaging covering the left and right ventricle for evaluation of EDV, ESV, SV, EF, CO and muscle mass.
* Phase Contrast Imaging: Flow measurements in the aorta, the pulmonary artery and the heart.
* Perfusion measurement.
* Late enhancement measurement: Multi-slice short axes view, multi-slice 2-chamber view and multi-slice 4-chamber view.

Eligibility Criteria:
Inclusion Criteria:

* Controls without history of cardiac or pulmonary diseases
* Patients with suspected PH
* Patients with latent PH
* Patients with manifest PH

Exclusion Criteria:

* MRI exclusion criteria