cyrilzakka/clinical-trials huggingface dataset:
Imaging Properties of PET Radiotracer [18F]3F-PHPG in Patients With Neuroendocrine Tumors

The goal of this exploratory study is to test whether \[18F\]3F-PHPG can be used reliably to map the locations of tumors in patients with neuroendocrine tumors. If so, the results of this study will be used to support further development of \[18F\]3F-PHPG as a clinical tool for neuroendocrine tumor localization and staging.

Subjects enrolled in this study will be recruited from the population of adult patients with neuroendocrine tumors, including pheochromocytoma and paraganglioma, being treated at the University of Michigan Hospital.

The primary objective of the study is to obtain basic information on the biodistribution and pharmacokinetics of \[18F\]3F-PHPG in cancer patients with neuroendocrine tumors.

The secondary objective of the study is to compare the diagnostic performance of \[18F\]3F-PHPG in cancer patients with neuroendocrine tumors with the FDA approved radiopharmaceuticals \[123I\]metaiodobenzylguanidine (\[123I\]MIBG) and \[68Ga\]DOTA-TATE in the same patients. A group of approximately 12 of the subjects scanned with \[18F\]3F-PHPG will be recruited to undergo a whole-body \[123I\]MIBG scan using planar scintigraphy with a gamma camera, following the standard clinical protocol used at the University of Michigan. In addition, a single SPECT/CT scan of the primary neuroendocrine tumor will be acquired after the whole-body scan to provide a tomographic image for comparison with the positron emission tomography (PET) image acquired using \[18F\]3F-PHPG. Several subjects enrolled on this study will undergo \[68Ga\]DOTA-TATE scans off-study, as part of routine clinical management. Existing \[68Ga\]DOTA-TATE scans will be obtained from consenting subjects' medical records.

This is an exploratory study and thus all statistical data analyses will be exploratory in nature.

Eligibility Criteria:
Inclusion Criteria:

* Current neuroendocrine tumor diagnosis
* Able to lie flat for 60 minutes
* Provision of informed consent

Exclusion Criteria:

* Pregnancy or lactation
* Claustrophobia
* Inability to lie flat for 60 minutes
* Currently taking medications that may alter PET scans of neuroendocrine tumors with these tracers, including any of the following:

  * Tricyclic antidepressants, which inhibit the norepinephrine transporter: desipramine, amitriptyline, imipramine
  * Cold medications containing the sympathomimetic amines: phenylephrine, phenylpropanolamine, pseudoephedrine
  * Nasal decongestants (some use phenylephrine as the active agent)
  * Cocaine (which inhibits the norepinephrine transporter)
  * Tetrabenazine (Xenazine), which inhibits the VMAT2 transporter
  * Monoamine oxidase inhibitors (MAOI)
  * Some antihypertensive drugs: reserpine, labetalol, α-methyldopa, clonidine
Bioequivalence Study of Montelukast Sodium Oral Thin Film and Chewable Tablet in Fed Healthy Volunteers

This study aimed to evaluate the pharmacokinetic characteristics of montelukast sodium oral thin films and the bioequivalence between oral thin films and chewable tablets in healthy chinese volunteers under fed condition.


Eligibility Criteria:
Inclusion Criteria:

* Fully understood and voluntarily signed the informed consent form
* With high compliance
* BMI 18.6-28.5 kg/m\^2, and with weight ≥ 50 kg for male, or ≥ 45 kg for female

Exclusion Criteria:

* Allergic to any component of study drugs, other leukotriene receptor antagonists, sulfonamides, or non-steroidal anti-inflammatory drugs
* With clinically relevantly abnormal vital sign, examination, or clinically relevant disease
* Had drug abuse within 3 months before screening or positive in drug of abuse test
* With any routine use of drugs
* Received major surgery within 6 months before study drug administration or planned to receive major surgery during study period
* With average number of cigarettes smoked \> 5/day within 3 months before screening or refused to suspend smoking from 24 hours before study drug administration throughout study period
* With average alcohol consumption \> 14 units/week within 6 months before screening or refused to suspend alcohol consumption from 24 hours before study drug administration throughout study period
* With average tea, coffee, or other drink with caffeine consumption \> 8\*250 mL/day, or refused to suspend tea, coffee, other drink with caffeine, or grape fruit juice consumption from 24 hours before study drug administration throughout study period
* Lost or donated blood \> 200 mL within 3 months, or donated platelet \> 24 U within 1 months before study drug administration
* Received any drug within 14 days before study drug administration
* Received any drug of other clinical trial within 3 months before study drug administration
* Received any vaccine within 4 weeks before study drug administration
* Planned for pregnancy within 3 months after informed consent form signed or refused to use adequate contraception (excluding contraceptive drug)
* For female, pregnant, breastfeeding, received oral contraceptives within 30 days, or contraceptive injection or implant within 6 months before study drug administration
* For pregnancy-capable female, had unprotected sexual contact within 14 days before study drug administration
Registry Protocol- Melphalan Percutaneous Hepatic Perfusion for the Treatment of Unresectable Hepatic Malignancy

Collection of Safety, Efficacy and Resource Utilization Information in Patients Who Have Received Melphalan PHP with the Delcath Hepatic Delivery System for the Treatment of Unresectable Hepatic Malignancy

Post Marketing study:

The CHEMOSAT kit containing Gen 2 filters has been used to treat patients since April 2012. This registry study is designed to collect safety, resource utilization and treatment outcomes in patients who receive this treatment with CHEMOSAT by healthcare professionals. The safety and efficacy data from patients treated with CHEMOSAT is important in updating the safety profile and for collection of treatment information. The resource utilization information is essential in planning treatment strategy for patients.

This registry does not follow any pre-determined protocol with respect to diagnosis, treatment or follow-up of the patient. The data collected will be gathered exclusively from current medical practice at participating institutions.

Delcath holds a list of authorized customer hospitals to whom it supplies the CHEMOSAT System. To date these hospitals have treated over 300 patients with cancers of the liver.

The decision to treat with CHEMOSAT is clearly separated from the decision to collect data in the registry. No specific procedures or tests are required in this protocol.

Eligibility Criteria:
1. Have received CHEMOSAT treatment per IFU within the last 6-months or are planned to receive treatment with CHEMOSAT.
2. Have provided written informed consent according to institutional and regulatory guidelines
Validation of a Non-Motor Fluctuation Assessment Instrument (NoMoFA) for Parkinson's Disease

Investigators have developed a comprehensive questionnaire that assesses the presence of non-motor fluctuations (NMFs) in individuals with Parkinson's disease (PD). To date, 189 participants with PD have been assessed for preliminary data analysis prior to developing the penultimate version. At this time the objectives are to: (i) assess the scale's internal consistency and item-to-total correlations; (ii) assess test-retest reliability; (iii) use factor analysis and reliability measures to guide item reduction; (iv) assess construct validity; and (v) assess the scales ability to discriminate between static non-motor symptoms and non-motor symptoms which fluctuate (vi) estimate the relative distribution of cognitive, psychiatric, autonomic, sleep and sensory NMFs in PD patients with motor fluctuations and their impact on quality of life in Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Idiopathic Parkinson's Disease (according to the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria)
* Stage of symptoms is mild, moderate or severe as per the Hoehn \& Yahr scale
* Have motor fluctuations
* Have non-motor fluctuations

Exclusion Criteria:

* Atypical Parkinsonism
* Lack of motor fluctuations
* Lack of English language proficiency in either subject or caregiver
Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-ALL

A Clinical Study on the Safety and Effectiveness of targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-ALL

In this study, 30 patients with relapsed refractory T-ALL were proposed to undergo CD5 CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD5 CAR-T Cells therapy for relapsed refractory T-ALL; At the same time, on the basis of expanding the sample size, more safety data on CD5 CAR-T Cells treatment for relapsed refractory T-ALL were accumulated.

Eligibility Criteria:
Inclusion Criteria:

* 1. According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020. v1), patients diagnosed as CD5+T-ALL;
* 2. Consistent with r/r CD5+T-ALL diagnosis, including any of the following conditions:

  1. No CR after standard chemotherapy;
  2. The first induction reaches CR, but CR ≤ 12 months;
  3. Patients with r/r CD5+T-ALL have not responded to the first or multiple remedial treatments;

  c.Multiple recurrences.
* 3. CD5 expression rate was \>90%;
* 4. Number of blasts in the bone marrow (protolychic + larvae) \>5% (morphology) and/or \>1% (flow cytometry);
* 5. Total bilirubin ≤51 (mol/L), Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 3 times the upper limit of the normal range, creatinine ≤176.8 (mol/L);
* 6. Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;
* 7.Refers to the pulse oxygen saturation 92% or higher oxygen (state);
* 8.Estimated life expectancy of minimum of 12 weeks;
* 9.ECOG 0-2;
* 10.Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
* 11. Those who voluntarily participated in this trial and provided informed consent;

Exclusion Criteria:

* 1.Patients with the history of epilepsy or other CNS disease;
* 2. Patients with prolonged QT interval time or severe heart disease;
* 3. Active infection of hepatitis B virus, C virus or hepatitis E virus;
* 4. Active infection with no cure;
* 5. Before using any gene therapy products;
* 6. Received anti-tumor therapy before infusion, should meet the following any one should be ruled out:

  1. treated with systemic corticosteroids therapy within 72 hours (except glucocorticoid physiological replacement therapy, such as prednisone \< 10 mg/d or an equivalent dose of the drug);
  2. received within 72 hours of small molecule targeted therapy;
  3. 2 weeks received systemic chemotherapy except (pretreatment);
  4. four weeks received radiotherapy;
* 7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
* 8. Any unsuitable to participate in this trial judged by the investigator;
* 9. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.
The Role of Contrast Enhanced Ultrasound in Appendicitis

This study seeks to determine the efficacy of Contrast Enhanced Ultrasound (CEUS) in improving the diagnosis of acute appendicitis in children, when compared to the standard grey-scale ultrasound.

This will be a single-center, non-randomized trial that will add to our institution's current diagnostic algorithm using Contrast Enhanced Ultra Sound (CEUS) in subjects who are clinically suspicious for acute appendicitis.

For those who consent to study participation, we propose obtaining a CEUS after the initial gray-scale ultrasound. Once the initial ultrasound is complete, the contrast Lumason® (sulfur hexafluoride lipid type-A microspheres) will be administered through an already existing IV catheter and an abdominal scan will be completed. The patient will then continue with standard of care treatment per his treating physician. The CEUS image will be read at a future time by a Children's Mercy Hospital radiologist blinded to the results of the gray scale ultrasound and computed tomography (CT) scan if one was obtained; these will be used for comparison.

Eligibility Criteria:
Inclusion Criteria:

* Present to Children's Mercy Adele Hall campus with a clinical concern for acute appendicitis
* Age 8 through 17 years
* seen between Institutional Review Board (IRB) approval date and 12/31/2019
* Seen Monday- Friday between the hours of 9:00 a.m. and 4:00 pm
* Has had an IV catheter placed as part of their standard of care

Exclusion Criteria:

* Known cardiac abnormality
* Pulmonary hypertension
* Known sensitivity to sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), or palmitic acid
* Does not had an IV catheter placed
* Unable to roll over
* Unable to assent
* Pregnant
* Lactating
* Received an ultrasound image from a referring facility
Swiss Study on Subarachnoid Hemorrhage

This registry was created to assess management parameters of patients treated for aneurysmal subarachnoid hemorrhage in Switzerland. All Swiss hospitals with a neurosurgery department, an intensive care unit and an interventional neuroradiology team that treat neurovascular emergencies participate in the registry. Clinical parameters are entered into a common database. This database will provide (1) a nationwide assessment of the current standard of care and (2) the outcomes for patients in Switzerland including neuropsychological assessments.

Overview:

The management of aneurysmal subarachnoid hemorrhage (aSAH) in Switzerland has not been assessed on a national level to date. The investigators united all comprehensive neurovascular care centres in Switzerland to create a registry for aSAH. This registry helps collect clinical and management data from different centres and pools it in one common database. It may provide referring caregivers and healthcare providers with a critical tool to assess the quality of care in a disease which has a high socio-economic burden. Moreover, it may serve as a tool to foster scientific collaboration and address a number of remaining questions about the management of aSAH in the future. Regarding SAH, data from the federal statistics bureau of Switzerland are based strictly on ICD-10 codes provided by hospitals and show an estimate of 13 per 100,000 in a population of roughly 8 million (http://bfs.admin.ch). These numbers, however, are not referring to aneurismal SAH exclusively and thus exceed the numbers which the investigators expect to obtain. The goal is to obtain complete recruitment of SAH patients throughout Switzerland, and the goal is therefore that assessment of incidence will be performed later on.

Data management:

Data is entered into a central online database created by the Secutrial platform. This platform is provided by the University Hospital of Geneva's Clinical Research Unit. The database disposes of an audit-trail capacity. Local principal investigators are responsible for data-cross check and quality management. Source data verification is performed by investigators on site who address missing data. Regular meetings are held to discuss data patency.

The platform automatically provides a report on recruitment progress.

Eligibility Criteria:
Inclusion criteria:

- Patients admitted with a proven diagnosis of aneurysmal subarachnoid hemorrhage.

Exclusion criteria:

- Patients in whom the source of haemorrhage could not be identified (angiogram-negative SAH) or SAH with other causes than cerebral aneurysms.
Improvement in Baroreflex Sensitivity in OSAS

Individuals with obstructive sleep apnea syndrome (OSAS) are at high risk for cardiovascular morbidity and mortality. The effect of long-term nocturnal therapy with continuous positive airway pressure (CPAP) on daytime baroreflex sensitivity (BRS), a predictor of cardiac death, was investigated in OSAS patients.


Eligibility Criteria:
Inclusion Criteria:

* obstructive sleep apnea syndrome

Exclusion Criteria:

* diabetes mellitus, chronic obstructive lung disease, coronary or valvular heart disease, congestive heart failure, renal failure, or endocrine dysfunction. Moreover, none of them were taking b-blockers, vasodilators, or inotropic agents at the time of enrollment in the study.
Sleep, Circadian Rhythms and Cluster Headache

The purpose of this study is to assess both the sleep and circadian (24-hourly biological rhythms) physiology of people with cluster headache. For sufferers with the episodic form of the disorder this will involve observation at two separate time points, once when experiencing attacks (in-bout) and once when attack free (out-of-bout).

The study will include measurement of basic rest-activity patterns, sleep timing and timing of individual attacks, as well as a more detailed study recording sleep and circadian rhythms under clinical conditions over consecutive nights.

Studying the differences in these processes in single individuals when they are both experiencing and free from attacks might provide insight into the brain mechanisms involved in triggering the bouts of attacks and individual attacks themselves. An improved understanding of this area may help design improved treatment options in future.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cluster headache or closely related primary headache disorder

Exclusion Criteria:

* Abnormality on screening investigations that increase risk of participation
* Alcohol consumption exceeding 21 units per week
The "One-piece" Autologous Tuberosity Graft

A prospective study investigating clinically and radiologically the effectiveness of the use of a combined hard and soft tissue graft retrieved from the maxillary tuberosity and designed for alveolar ridge preservation following tooth extraction.

Patients scheduled for a single mono-rooted tooth extraction are included in the study. After atraumatic extraction, sockets are filled with a "one-piece" dual tissue graft harvested from the tuberosity using an adjusted trephine. CBCTs are performed before the extraction and 4 months after ridge preservation, to analyze the vertical and horizontal alterations of the ridge, using 'ITK-Snap' software.

Clinical measurements of both soft and hard tissues are also assessed during the extraction and implant placement.

Eligibility Criteria:
Inclusion Criteria:

* Healthy patient
* Patient with at least one single-rooted tooth to be extracted and be replaced with an implant
* No signs of acute infection : edema, suppuration, abscess, spontaneous bleeding
* Non-smoker or Light Smoker \< 10 cigarettes/day

Exclusion Criteria:

* Pregnant or lactating females
* Non-controlled periodontal disease
* Medical conditions that contraindicate implant surgery
* Metabolic bone disorders such as osteoporosis,..
* Severe psychiatric conditions
* Heavy smoker \> 10 cigarettes/day
Developing and Testing Motherly App: a Smartphone Application to Promote Mothers' Mental Health

The investigators plan to develop and test Motherly, a smartphone app to promote maternal mental health and child development. The Motherly app is visually appealing aimed at engaging the user with a minimalistic layout. The app will offer a gamified experience ideal for engaging youth in behaviors that can promote mental health, such as stimulating pleasure, productivity, and physical activities, connecting with peers, and eating healthy food. Pregnant women aged 16-34 living in Brazil will participate in the clinical trial to test the efficacy of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Literate women in the first or second trimester of pregnancy
* Living in Brazil
* Owning a functional smartphone for personal use with Android or iOS operational system

Exclusion Criteria:

* High-risk pregnancy
Low-Cost and Reusable Thermal Jacket for Managing Preterm or Low Birth Weight Neonates.

Globally, over 15 million neonates are born preterm each year. They account for approximately 30% of global neonatal deaths and 19% of total neonatal deaths in Bangladesh. They usually die because they cannot maintain normal temperature due to their weight, immature skin and underdeveloped thermal regulatory capacity of the brain.

Maintaining continuous KMC for at least 16-20 hours/day, is sometimes not feasible for mothers or caregivers. In addition, we also have the challenge of keeping preterm or LBW neonates warm during transportation.

The scientists at icddr,b, Johns Hopkins University, and George Mason University developed the re-usable thermal jacket for keeping preterm or low-birth-weight neonate warm. We propose to build on previous work by systematically testing the safety of the 'thermal jacket' among preterm or low birthweight (LBW) neonates.

Objective of this study is to conduct clinical safety trial of the thermal jacket to test whether the thermal jacket can retain euthermia of preterm or LBW neonates for 2 hours.

We will equip a single arm trial with no control group design, in which every enrolled neonate will get the experimental therapy (thermal jacket) for this phase. A thermal jacket trial on a preterm or LBW neonate will be considered an event. An event will be considered a success if the neonate can maintain the body temperature in the euthermic range (36.5°C-37.5°C) using the thermal jacket for two hours. Thus, the failure event will be if the thermal jacket fails to maintain euthermia for neonates for two hours. Suppose, the neonate's body temperature drops below 36.5°C or rises above 37.5°C, the neonate will be monitored for maximum 5 minutes. If not recovered from the state, the neonate then immediately will be removed from the event for the appropriate management under the study's responsibility.

Eligibility Criteria:
Inclusion Criteria:

1. Neonate aged between 0-72 hours
2. Birthweight between 1800g to 2000g
3. No gross congenital anomaly
4. Normal heart 100-160 per minute
5. Capillary Refill Time ≤3 sec
6. Respiratory rate 30-59 per minute
7. Breaths comfortably (no chest indrawing, No gasping)
8. No sign of respiratory distress (respiratory rate within normal limit)
9. Pink in room air (without oxygen therapy)
10. H/O No prolonged or frequent apnea \& no visible apnea during study enrolment
11. No major surgical problem

Exclusion Criteria:

1. In nasogastric tube
2. In oxygen therapy
3. In intravenous fluid
A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants

The main purpose of this study is to evaluate amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via pre-filled syringe compared to mirikizumab (reference) solution given via pre-filled syringe. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated.

Screening is required within 35 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Have a body mass index( BMI) within the range of 18.0 to 34.0 kg/m2, inclusive.
* Are males or non-pregnant women of childbearing potential (WOCBP) or women not of childbearing potential (WNOCBP).

Exclusion Criteria:

* Have significant allergies to humanized monoclonal antibodies or known allergies to mirikizumab, related compounds or any components of the formulation, or history of significant atopy
* Have an abnormal blood pressure, pulse rate, or temperature as determined by the investigator
* Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing
* Are lactating or pregnant