cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Pharmacokinetics and the Safety of M518101 in Plaque Psoriasis Patients

This study is to evaluate the pharmacokinetics and safety of M518101 in male and female plaque psoriasis patients.


Eligibility Criteria:
Inclusion Criteria:

* Who are able and willing to give signed informed consent
* Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator.
* Who have ≥20% of body surface area (BSA) afflicted with plaques
* Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.

Exclusion Criteria:

* Who have a history of allergy to vitamin D3 derivative preparations or a history of relevant drug hypersensitivity.
* BMI \> 32.0 kg/m2
* Who are pregnant or lactating.
* Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
* Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
* Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study.
* Whose serum calcium levels exceed the upper limit of reference range
* Who have used any investigational medicinal product and/or participated in any clinical study within 60 days of randomization.
* Who have taken any durg with known effects on calcium metabolism within 30days of randomization
* Who have been treated with any drug with a known risk of QT prolongation within 30days of randomization.
Surgical Intervention and the NETest

The purpose of this study is to evaluate the effect of different surgical resections (R0, R1, R2) on circulating NET transcripts (PCR score or NETest). A drop in circulating NET levels will be correlated with surgical excision. Secondly, variation of circulating NET transcripts will be correlated to NET recurrence to test whether this analysis may constitute an early predictive marker of disease relapse.

Biomarker-based tools that can accurately predict gastroenteropancreatic neuroendocrine tumor (GEP-NET) treatment response and tumor recurrence are currently not available. Circulating biomarkers that are associated with GEP-NETs are limited to measurements of plasma chromogranin A (CgA). The investigators have developed a PCR-based tool to quantitate (score) the circulating GEP-NET molecular signature ("liquid" biopsy) with high sensitivity and specificity. This signature can identify all types of GEP-NETs including small (1cm) non-metastatic tumors, is significantly reduced after tumor debulking and is decreased following surgical "cure". Elevated post-surgical scores are associated with tumor recurrence within 6 months in \~40% of cases. Current NET treatment protocols are associated with tumor recurrence (progression free survival) ranging from 5-18 months. The majority of patients will experience a relapse within 18 months irrespective of the treatment approach. The investigators hypothesize that a PCR measurement of circulating NET mRNA can accurately predict the extent of surgical resection (tumor removal) and elevated scores can predict tumor relapse before this occurs. This biomarker protocol seeks to test this hypothesis and evaluate whether changes in plasma CgA are as effective in predicting resection and recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed, well differentiated (G1, G2 or G3), local and advanced (metastatic), neuroendocrine tumor of gastro-enteropancreatic origin.
* Treatment-naïve as well as patients who have received previous therapies.
* Patients currently on LAR with clinically stable disease.
* CT or MRI documentation of disease.
* WHO performance status ≤2.

Exclusion Criteria:

* Known history of HIV seropositivity
Optical Surface Monitoring Technology-Guided Large-Segment Radiotherapy for Breast Cancer

This study is a single-center,blinded, efficacious, phase III randomized clinical trial initiated by investigators. The primary objective is to investigate the use of Surface Guided Radiation Therapy (SGRT) in combination with Deep Inspiration Breath Hold (DIBH) technique for left breast cancer treatment, compared to traditional laser alignment with free breathing treatment. This approach offers superior positioning accuracy and improved heart protection without any increase in radiation or adverse reactions.

This is an investigator-initiated blinded, efficacious, phase III randomized clinical trial study. The study hypothesis is that the use of Surface Guided Radiation Therapy (SGRT) in combination with the Deep Inspiration Breath Hold (DIBH) technique for left breast cancer treatment can improve positioning accuracy and heart protection without any increase in radiation or adverse reactions. The primary endpoint of this study is the accuracy of the treatment location and incidence of patient coronary events/myocardial perfusion decline.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have undergone breast-conserving surgery or modified radical mastectomy for left breast cancer;
2. Planned whole-breast ± supraclavicular region, chest wall ± supraclavicular region radiotherapy;
3. Able to perform deep inspiration breath-hold technique with breath-holding time \>35s and can repeat it continuously for more than 6 times;
4. Patients who have not received neoadjuvant chemotherapy or breast reconstruction surgery;
5. No active heart disease, myocardial infarction, congestive heart failure or other cardiac diseases at baseline;
6. Patients are fully voluntary and able to sign the informed consent form 30 days before enrollment.

Exclusion Criteria:

1. Bilateral breast cancer;
2. No pathological diagnosis;
3. Remote metastasis;
4. Receiving neoadjuvant chemotherapy or breast reconstruction;
5. Have received mediastinal radiotherapy in the past;
6. Previous history of abdominal or pelvic radiotherapy;
7. Previous or secondary primary malignant tumor;
8. Serious cardiac insufficiency; Myocardial infarction or uncorrected unstable arrhythmia or uncorrected unstable angina pectoris occurred in the last 3 months; Pericardial disease.
COntact RElationship in Neonatal Intensive Care Unit

The present research project aims to explore the value that contact relationships between caregivers and the preterm infant may have in terms of promoting developmental and maturational processes,by attending to the neurobehavioral states of the infant in response to maternal and paternal voice.

The study is aimed at furthering the still underdeveloped knowledge regarding the possible effects of the paternal voice on the neurobehavioral states of the preterm infant in the crib, comparing them with the effects of exposure to the maternal voice and the voice of a familiar but non-parental figure, such as the NICU nurse.

These behavioral states will also be observed as a function of the psychological condition of the parents, investigating the presence of a possible postpartum depressive condition and/or anxiety of the mother and symptomatology attributable to perinatal affective disorders in the fathers, which are often overlooked; and again, the neurobehavioral responses of the infants will be correlated with the neurophysiological responses of the parents/nurses who interact with them through voice and touch.

The research aims to have a direct impact on both parents and health care personnel: in addition to questionnaires dedicated to screening parents for perinatal psychological disorders, artificial intelligence systems will be used to intercept possible postpartum depression early by recording the maternal voice, enabling the activation of a psychological support intervention and reducing the negative impact that a postpartum depression has on the early mother-child relationship. In addition, information on parent-child interactive modalities will be able to further guide the intake of assignment and particularly the accompaniment of parents during the time of hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* For infants: Infants with gestational age between 33 and 36 weeks, weighing around 2kg (LBW - low birth weight), in whom life-threatening conditions have been averted and in stable medical condition will be included in the study.
* For parents: Male and female adults aged between 18 and 50 years.

Exclusion Criteria:

* For infants: Presence of congenital anomalies, neurological disorders, genetic syndromes, and any other condition of developmental atypicality.
* For parents: Parents under 18 years of age; Parents with diagnosed psychiatric disorders and/or sensory disabilities; single parents.
Infrared Low-level Laser Therapy Before Intense Progressive Running Test of High-level Soccer Players

Photobiomodulation therapy (PBMT) has recently been used to alleviate postexercise muscle fatigue and enhance muscle recovery, demonstrating positive results. A previous study by the investigator's research group demonstrated the optimal dose and the optimal output power (100 mW) for an infrared wavelength (810 nm). However, the effects of optimized PBMT on performance and post-exercise recovery in high-level soccer players, to date have not been evaluated.

The present research project aims to evaluate the effects of PBMT (using low-level laser therapy) applied before a progressive running test on functional, muscle damage, inflammatory and oxidative stress markers in high-level soccer players.

To achieve the proposed objective it will perform a randomized, crossover triple-blinded, placebo-controlled trial, with high-level soccer players as volunteers.

Twenty-two volunteers will be randomly allocated to two intervention groups: active or placebo PBMT before a progressive running test (ergospirometry test).

The blood samples for biochemical analysis will be obtained before and after a progressive running test, and another outcomes (functional) will be obtained during the test.

The data will be collected by a blind assessor. The statistical analysis will follow the intention-to-treat principles and data on functional analysis will be analyzed using the paired and two-tailed t-student test. Data on biochemical analysis will be analyzed using two-way ANOVA, followed by Bonferroni post hoc test.

The investigators will analyze: functional aspects (rates of oxygen uptake -VO2max (absolute and relative), aerobic and anaerobic threshold and time until exhaustion), muscle damage (creatine-kinase -CK and lactate dehydrogenase -LDH), inflammatory markers (IL-1β, IL-6 and TNF-α) and oxidative stress markers (Thiobarbituric acid -TBARS, catalase - CAT, superoxidedismutase - SOD and carbonylated proteins).

Eligibility Criteria:
Inclusion Criteria:

* High-level soccer players;
* Age between 18 and 35 years;
* Male gender;
* Minimum of 80% participation in team practice sessions;
* Agreement to participate through signed statement of informed consent.

Exclusion Criteria:

* History of musculoskeletal injury to hips or knees in previous 2 months;
* Use of pharmacological agents or nutritional supplements;
* Smokers and alcoholics;
* Occurrence of musculoskeletal injury during the trial;
* Any change in practice routine in relation to rest of the team during the trial.
Clinical Study of 12-week Trehalose Intake in Patients With Fatty Liver Disease

This clinical study will be conducted to evaluate the efficacy and safety of trehalose in patients with fatty liver disease. After 12-week intake, subjects will be checked up fat content in liver using CT scan.


Eligibility Criteria:
Inclusion Criteria:

* Age between 19-year-old and 79-year-old
* Weight (≥50kg)
* Is diagnosed as fatty liver on ultrasonography within 24 weeks from screening day
* Has willingness and ability to participate whole clinical study period
* Willing to give informed consent form

Exclusion Criteria:

* Patient with alcoholic fatty liver
* Patient with inflammatory bowel disease
* Is required treatment for like liver, kidney, digestive system, circulatory system, respiratory system, endocrine system(except diabetes), musculoskeletal, neuropsychiatry, or hemato-oncology etc., which is able to effect on clinical study
* Has any medical history with virus or toxic hepatitis
* Has any medical history of gastrointestinal surgery (except simple appendectomy \& repair of hernia)
* Has medical history of malignant tumor (except non-melanoma skin cancer) within the last 5 years from the screening day
* Took any drugs (UDCA, silymarin, omega-3, fenofibrate etc.) which is decided as unsuitable drug for combined-dose by investigator
* Over 4 times of maximum reference range of ALT or AST
* Average drinking quantity per week \> alcohol 140 g
* Pregnant or nursing women
* Is currently participating into another clinical study
* Being made a decision from investigator as unsuitable to participate this study
Oral and Swallowing Function in Older Adults

The purpose of this study is to learn about oral and swallowing function in older adults presenting to the emergency department. The hypothesis is that older adults often have problems with oral and swallowing function and these problems relate to other conditions. Study activities are done during the emergency department visit and include providing saliva samples, completing a bedside water swallow test, completing oral function assessments, completing respiratory function tests, and answering survey questions.

Oropharyngeal dysphagia is characterized by changes in swallow event timing, biomechanics, and pressure generation that occur with advancing age resulting in aspiration of bacteria-laden saliva, food, and liquid into the lungs. Currently, oral and swallowing function is not routinely or comprehensively assessed in older adults despite poor oral health and oropharyngeal dysphagia being known risk factors for pneumonia, the leading infectious cause of mortality among adults 65+. This study seeks to extensively characterize oral and swallowing function in older adults presenting to the emergency department to clarify the relationship of oral hypofunction, dysphagia, and the upper airway microbiome. To achieve this aim, study procedures include a bedside dysphagia screen, oral health assessment, tongue pressure measurement, masticatory function assessment, respiratory function tests, salivary compositional analysis, oral microbiome analysis, and microphysiological system analysis which applies saliva samples to a bronchiolar lumen model to mimic aspiration and quantify cellular and tissue responses to the saliva microbiome and secreted mediators.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60
* Clinically stable and able (not NPO) to safely drink water and eat a saltine cracker per ED provider

Exclusion Criteria:

* Prisoner
* Non-English speaking
By Assessing the Continuous Respiratory Physiological Changes Through Prone Position, Determine the Optimal Duration for Prone Position

The prone position leads to a more homogeneous distribution of ventilation by inflation of collapsed alveoli and reduction in alveolar hyperinflation. By employing EIT, the study can obtain a thorough comprehension of the ongoing alterations in regional ventilation before and after adopting the prone position. It is also anticipated that there is an impact on inflammation biomarkers before and after the prone position. This assessment aids in determining the ideal duration for prone position therapy, encompassing the necessary hours and days in the prone position.

The prone position leads to a more homogeneous distribution of ventilation by inflation of collapsed alveoli and reduction in alveolar hyperinflation. By employing EIT, the study can obtain a thorough comprehension of the ongoing alterations in regional ventilation before and after adopting the prone position. It is also anticipated that there is an impact on inflammation biomarkers before and after the prone position. This assessment aids in determining the ideal duration for prone position therapy, encompassing the necessary hours and days in the prone position.

Therefore, the investigators propose a project with the aim of collecting relevant clinical, laboratory, imaging, and respiratory physiology data from consenting patients with ARDS within the study period. The objective is to analyze changes in biomarkers following prone position.

Eligibility Criteria:
Inclusion Criteria:

1. Acute respiratory distress syndrome
2. Age \> 18
3. Serial arterial blood gas data：PaO2/FiO2 \<150. The mechanical ventilator setting：FiO2\>0.6, PEEP\>5 cmH2O

Exclusion Criteria:

1. Implantable electronic devices (e.g., pacemakers)
2. Body mass index \> 30
3. Major thoracic and abdominal surgery
4. Patients with unstable spine and pelvis conditions
5. Pregnant women in the second and third trimesters
6. Patients with head trauma, elevated intracranial pressure, or elevated intraocular pressure
7. Hemodynamically unstable patients unsuitable for prone ventilation therapy
8. Patients with active seizures
A Study to Evaluate the Effect of Formulation and Food on MK-1084 in Healthy Adult Participants (MK-1084-011)

This study has 2 parts. Researchers want to learn what happens to MK-1084 in a healthy person's body over time in both parts. The goals of the study are:

* In Part 1, to compare what happens to MK-1084 in a person's blood when it is taken as 2 different types of oral tablets
* In Part 2, to learn what happens to MK-1084 in a person's blood when it is taken on an empty stomach or after a meal


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

- Has a body mass index ≥18.0 and ≤32.0 kg/m\^2

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has a history or presence of a clinically significant medical or psychiatric condition or disease
* Has a history of cancer (malignancy)
* Has positive results for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus
Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System

To evaluate the acute and long-term clinical outcomes of tenotomy with the TenJet System in patients with elbow tendinosis.

This is a prospective, non-randomized, single arm post-marketing clinical study of patients undergoing percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System to treat elbow tendinosis. Patients will be followed for a maximum of 12 months post-procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patient is \> 18 years of age
* Chronic lateral or medial elbow pain \> 3 month duration
* History and clinical examination consistent with lateral or medial epicondylitis
* Sonographic evidence of medial or lateral elbow tendinosis as evidenced by

  * tendon thickening and hypoechogenicity,
  * with or without hypervascularity on Doppler examination and,
  * with or without cortical irregularities, Or MRI findings consistent with lateral or medial tendinosis, with or without intrasubstance tear.
* \> 3 months of non-operative treatment that included

  * nonsteroidal anti-inflammatory drugs
  * activity modification
  * physical therapy
  * elbow straps
  * With or without previous steroid injections, protein rich plasma injections, or stem cell injections
* Patient is willing and able to provide informed consent and comply with the study protocol

Exclusion Criteria:

* Documented ipsilateral upper extremity musculoskeletal condition (other than elbow tendinosis in the same arm on the opposite side)
* Bleeding disorders and/or current use of anti-coagulants with the inability to withhold anticoagulants for required time prior to procedure
* Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 7 days of treatment
* Steroid injection within 4 weeks of the study procedure
* Active local or systemic infection
* Patient found to have further degenerative changes of the elbow contributing to pain, such as cartilage thinning, loose body, or evidence of tendinosis other than medial or lateral, including triceps or ulnar collateral ligament.
* Patient is known or suspected to be pregnant
A Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1

The purpose of the protocol is to assess long-term safety and tolerability of subjects who discontinue for any reason from UK-453,061 qualifying studies.

To assess long term safety and tolerability of subjects who discontinue for any reason from UK-453,061 studies. The study will also assess efficacy of the subsequent regimens in these patients. The trial was terminated prematurely on January 29, 2013, due to the decision of the sponsor to discontinue development of lersivirine. The decision to terminate the trial was not based on any safety or efficacy concerns.

Eligibility Criteria:
Inclusion Criteria:

* Previous participation in a qualifying study.
* Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.

Exclusion Criteria:

* Concurrent treatment in another clinical trial.
* Unwilling or unable to be followed for 12 months
Magnetic Resonance Imaging Study on Patients With Hemifacial Spasm

Up to now, multiplanar reconstruction (MPR) has been widely used to detect the neurovascular compressions (NVC) on the patients with hemifacial spasm (HFS). However, due to lack of stereoscopic vision, this traditional method sometimes can not meet the requirement on identifying the details of NVC, especially when the aberrant vessels turn out to be veins not arteries. The three dimensional analytic techniques, such as curved planar reconstruction (CPR) and magnetic resonance virtual endoscopy (MRVE), may be helpful to improve the sensitivity and specificity on the demonstration of NVC with stereo and dynamic views, so as to assist the design of the surgical plan.

Furthermore, the frequent finding of NVC on MRI studies of asymptomatic patients incited the creation of several strict criteria for the imaging diagnosis of NVC: the vessel must cross perpendicular to the long axis of the nerve, the nerve must be deviated or indented at the root entry zoon (REZ) by the vessel. Alternatively, morphological measurement of the nerve may correlate with the severity of facial spasm due to atrophy of the nerve in most cases of HFS, and is likely secondary to the micro-structural abnormalities, such as axonal loss, demyelination, collagen deposition, etc. In this study, cross-sectional area (CSA) and volume (V) of the cisternal facial nerve will be assessed to determine whether it can be a useful biomarker for predicting the degree of HFS.


Eligibility Criteria:
Inclusion Criteria:

* Primary HFS patients according to medical history and typical facial muscle spasms that are unilateral, involuntary, and had intermittent contractions innervated by the ipsilateral facial nerve. The patient has 1 year disease duration at least.

Exclusion Criteria:

* Secondary causes of HFS, such as tumors or cysts compressing the facial nerve in the cerebellar pontine cistern; Precarious general health status; Percutaneous lesions or surgical treatments; Cardiac pacemaker or metal implants.