cyrilzakka/clinical-trials huggingface dataset:
Early Prediction of QFR in STEMI-I

The study intends to provide important data on whether the noval method using quantitative flow ratio could predict microvascular dysfunction.

Microvascular dysfunction (MVD) is a serious complication of PCI, which happens frequently after STEMI and always correlates with a poor prognosis. However, precise and simplified assessment of MVD is difficult, especially in the acute phase of STEMI patients. Resent studies suggested that FFR could be overestimated when MVD exists. But whether the overestimated value of FFR caused by CMR defined MVO could reflect microcirculation function is still unclear.

This study is a retrospective study using STEMI patients with TFG 2/3 of the infarct vessel on initial angiography and presumed culprit lesion ≥50% as the population. Contrast-enhanced CMR was performed 5 days after PCI as the reference standard.

Eligibility Criteria:
Inclusion Criteria:

* STEMI patients treated with revasculation within 12 hours from onset of symptoms to PCI time and received CMR 5 days afterwards. STEMI was defined as a combination of the following: chest pain for more than 30min, electrocardiographic (ECG) changing with ST segment elevation of \>2 mm in at least 2 precordial leads and \>1 mm in limb leads, and abnormal troponin levels or CKMB levels higher than twice the upper limit of normal.
* Patients with TFG 2/3 in the initial angiography of the culprit vessel.

Exclusion Criteria:

* Patients with left bundle branch block in the presenting ECG, cardiogenic shock, PCI or bypass surgery history.
* Patients with residual stenosis \<50%.
* Patients with unqualified coronary angiographic images with problems such as ostial lesion, severe vessel tortuosity and diffuse long lesions.
Evolution of Visual Impairment During Pseudoxanthoma Elasticum

Pseudoxanthoma elasticum is a disease whom frequency is estimated about 1/50000 to 1/100 000. There is a female preponderance with a sex-ratio of 2:1. PXE is transmitted according either to an autosomal dominant mode or to an autosomal recessive one. Mutations in the ABCC6 gene on chromosome 16p13.1 have recently been identified causing PXE. The elastic fibers slowly become mineralized mainly in the skin, the eyes, and the cardiovascular system. PXE is a multisystem disease that includes a spectrum of clinical manifestations affecting the skin, the eye or the cardiovascular system as well as other tissues. It can be responsible for severe and life threatening complications. Skin changes are usually the first manifestations and begin in early childhood. The vital prognosis of PXE depends on the severity of the cardiovascular lesions that could be responsible for sudden death in children and young adults.

Ocular manifestations are quite constant and include chorioretinal scarring, pigmentary changes or angioid streaks. The natural evolution of the angioid streaks leads to their enlargement or to the occurrence of subfoveal choroidal neovascularizations and hemorrhages leaving macular scares. A self-monitoring is recommended since early treatment of subfoveal CNV is the only way to minimize their pejorative consequences. The gold standard treatment of the CNV consists in the photocoagulation. New therapeutics has been developed including photodynamic therapy or intravitreal injection of anti-angiogenic agents and they seems to be effective to reduce the immediate complications of a limited CNV. This evolution explains that 50 to 70 % of the patients have a poor vision or legal blindness of one or both eyes. However, little is known about the age of occurrence of visual impairment in PXE patients. That is the reason why we decided to review the ophthalmologic status and visual history of our population of PXE patients according to their age.

A retrospective review of all cases of PXE patients referred by the Department of Genetics should be performed. This ophthalmologic examination has been conducted as part of the usual follow up for such PXE patients or for the needs of a treatment of complications of angioid streaks such as CNV complications.

As we studied the age of poor vision occurrence, we propose to take in account the first examination when a best-corrected visual acuity (BCVA) under 20/50 was observed. All past medical events obtains from the data of the patients will be recorded, especially ophthalmologic ones.

Eligibility Criteria:
Inclusion Criteria:

* pseudoxanthoma elasticum confirmed by the Department of Genetics according to the usual clinical, histological or genetic criterion.

Exclusion Criteria:

* No pseudoxanthoma elasticum
Brief and Intensive Therapy for Dysphagia in Patients With Head and Neck Cancer

According to data in the literature, patients with head and neck cancer, who undergo combined treatment of radio-chemotherapy, have, to a greater or lesser extent, swallowing changes. Most of the time, these patients undergo traditional speech-language interventions, performed weekly. This project proposes a brief and intensive therapy program for dysphagia, with daily interventions, showing that this therapeutic modality generates benefits in a shorter time interval when compared to traditional therapy. This short service period contributes to the reduction of hospital costs and reduces the total number of interventions, which is beneficial for both the patient and the service that performs the care. The present study was to verify the efficacy of a brief and intensive therapy program for dysphagia in patients with head and neck cancer submitted to radio-chemotherapy treatments, since they present, to a greater or lesser extent, changes of swallowing. This is a randomized clinical trial pilot project that will be developed in an oncology hospital. The population of this study is composed of patients diagnosed with head and neck cancer, over 18 years of age, with indication of combined radiotherapy , referred for speech therapy through the Multidisciplinary Oncology Outpatient Clinic of Santa Rita Hospital (AMOHR).

he sample will consist of 20 patients who will be randomized into two groups: 10 in the intervention group with intensive brief therapy and 10 in the control group with traditional weekly therapy. In both groups, instruments related to swallowing assessment and quality of life will be applied before and after speech therapy. The control group will receive speech therapy with weekly frequency, and the intervention group will participate in a brief and intensive therapy program that will take place during five days a week for three weeks, totaling fifteen sessions. The sessions will be of 40 minutes and, in both groups, the patients will receive care of individualized form, according to their needs.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients from 18 years of age;
* Diagnosis of head and neck cancer;
* Indication of combined treatment of radio-chemotherapy;

Exclusion Criteria:

* Have performed prior speech and hearing care for at least three months prior to the start of the study;
* Previous history of other neoplasias and / or neurological diseases, according to the participant's report and information of the medical record;
* Cognitive deficits and / or changes in the central nervous system that make it difficult to understand commands (illiterate individuals will have scores of at least 20 points, followed by 25 individuals from 1 to 4 years of study, 26.5 to 5 at 8 years, 28 to 9 to 11 years and finally, 29 to 11 years or more of schooling, according to Brucki et al., 2003).
* Cardiac problems, according to the participant's report and information on the medical chart.
* Do not attend therapy for more than three sessions.
Effect of Protein Supplement on Paraspinal Muscles in Spine Surgery

Protein intake in spinal fusion surgery can prevent paraspinal muscle atrophy by maintaining muscle mass, regeneration, and growth. Also, by reducing the amount of pseudarthrosis, pain and disability can have a positive effect on recovery.

The high prevalence of this type of surgery, the instability and degeneration of adjacent surfaces of fused sections, lumbar muscle atrophy, increased muscle tissue fat, and negative impact on patient recovery, also with regard to the fact that research has so far aimed to determine The effect of protein supplementation on para-spinal muscles has not been studied in patients undergoing posterior lumbar spine fusion surgery, therefore clinical trials are necessary. In this trial patients undergoing elective posterior spine fusion surgery are divided into two groups of intervention or control.

A randomized, double blind, controlled trial will be conducted in patients undergoing elective posterior spine fusion surgery in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 80 eligible posterior spine fusion surgery patients, aged ≥ 18 years. Intervention patients will be received 36 grams of protein supplement along with diet containing 1.2 g/kg/day of protein for 30 days after surgery and control patients will be received maltodextrin along with diet containing 1.2 g/kg/day of protein 30 days after surgery. Patients will be evaluated for occurrence of paraspinal muscles after 3 months surgery

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18-65 years
* Body mass index 18.5-30
* Candidate for the elective posterior spine fusion
* Without history of severe liver disorder
* Without history of Kidney disorder
* Without history of diabetes
* Without history of trauma and fracture of the vertebral
* Without history of osteoporosis
* Without history of Gastrointestinal malabsorption
* Without history of Parathyroid gland disorders
* Without taking medications that affect the metabolism of bone, such as calcitonin, bisphosphonate, corticosteroid
* No smoking
* Without history of neuromuscular diseases such as dystrophies and neurological disorders

Exclusion Criteria:

* Allergy or intolerance to protein or maltodextrine supplement
* Unwillingness to continue cooperation
A Study to Assess the Efficacy, Safety and Pharmacokinetics of EYU688 in Patients With Dengue Fever

The purpose of this study is to characterize the effect on dengue viral load, fever clearance time as well as on clinical signs and symptoms with the treatment of EYU688 compared with placebo in patients with dengue fever.

This is a randomized, participant- and investigator- blinded, placebo-controlled study to investigate the efficacy and safety of EYU688 administered orally in patients with dengue fever.

Due to the different PK sampling schedules applied, the study consists of two cohorts run in parallel (intensive PK \[cohort 1\] and sparse PK sampling \[cohort 2\]).

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 - 60 years old (inclusive).
* History or presence of fever (≥ 38°C). At least one of the following criteria indicating dengue infection:
* Nausea or vomiting.
* Presence of rash, aches or pains including headache, muscle or joint pain.
* Onset of fever ≤ 48 hours prior to treatment start.
* Positive test on dengue fever.

Exclusion Criteria:

* Participants with any of abnormalities of clinical laboratory parameters.
* Usage of any anticoagulant drugs.
* Current significant medical conditions or illness that the investigator considers should exclude the participants, especially those that require continuation of other medications likely to have an interaction with the study drug.
* Pregnant or nursing (lactating) women.
* Clinical signs and symptoms for severe dengue according to Dengue Guideline (WHO 2009) at screening.
* Participants with any of the following abnormalities of clinical laboratory parameters at screening:

  * Hemoglobin \<12.0 g/dL in males; \<11.0 g/dL in females
  * Hematocrit \>52 % in males; \>46 % in females
  * Absolute neutrophil count \<1500/μL
  * Platelet count \<80,000/mm3
  * Creatinine \>165 μmol/L in males; \>130 μmol/L in females
  * Serum creatine kinase \> 600 U/L
  * ALT, AST levels more than 1.5X upper limit of normal (ULN)
  * Total bilirubin \>24 μmol/L
* Usage of PPIs (proton pump inhibitor) which could affect absorption of EYU688 due to stomach pH value increase up to 48 hours prior to screening.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 4 days after stopping of investigational drug.
* History or long-QT syndrome, or clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening:

  * QTcF \> 450 msec (males)
  * QTcF \> 460 msec (females)

Other protocol-defined inclusion/exclusion criteria may apply.
Sentinel Lymph Node Mapping in Rectal Cancer

The purpose of this study is to develop a technique that allows physicians to identify the first lymph nodes draining from a rectal tumor (the sentinel lymph nodes). Currently, there is no technique used to find these lymph nodes in the rectum during surgery and therefore many patients with rectal cancer need to undergo a total rectal resection. Dyes, tracers, imaging and a gamma probe will be used in this study during a standard minimally invasive transanal endoscopic surgery (TES) to try to locate these lymph nodes. If surgeons are able to locate these lymph nodes they will be removed during surgery. If the technique is successfully developed as a result of this research, it could help patients in the future with early stage rectal cancer by allowing doctors to see if their cancer has spread to the lymph nodes of the rectum without having to undergo a total rectal resection. These patients would then be able to undergo a TES combined with a lymph node dissection to gain more knowledge about the stage of their disease. This knowledge would then be used to determine if and what further treatment is necessary for the patient's rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing elective transanal endoscopic surgery (TES) at the University of Virginia for rectal neoplasm (polyp with high grade dysplasia, T1N0 tumors \< 3cm in the absence of poor pathologic features, patients that refuse radical resection)
* Willing and able to give written informed consent

Exclusion Criteria:

* Patients less than 18 years of age
* Women who are pregnant and/or breastfeeding
* Prisoners
* Unable to give written informed consent
* Patients with any of the following:

  * Allergy to technetium, Spot and/or ICG
  * Allergy to iodides
  * Severe cardiac disease (hospitalization for cardiac disease in the last year, congestive heart failure, abnormal EKG) or renal disease (Creatinine \> 2.0 mg/dL)
* Patients with medical contradictions or have potential problems complying with the requirements of the protocol, in the opinion of the investigator
Propofol Versus Midazolam With Fentanyl for EGD Endomicroscopy

This trial aims to compare the endomicroscopic image quality and sedation efficacy of propofol or midazolam with fentanyl.


Eligibility Criteria:
Inclusion Criteria:

* outpatients attending endomicroscopy
* able to give written informed consent

Exclusion Criteria:

* GI tract malignancy
* coagulopathy
* acute upper digestive tract bleeding
* pregnancy or breast feeding
* allergy to fluorescein sodium
* impaired renal function
Multifunctional Nutrition Tube in Dysphagia for Nasopharyngeal Carcinoma

Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared.

Palliation to delayed dysphagia after radiotherapy for nasopharyngeal carcinoma (NPC) continues to be a challenge. Although nasogastric tube feeding (NGT) has been adopted widely, the weaknesses have yet to be improved by another enteral nutrition support mode. This study aims to observe the clinical efficacy of intermittent oro-esophageal tube feeding (IOE) in the treatment of delayed dysphagia after radiotherapy for (NPC). This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support.

Palliation to delayed dysphagia after radiotherapy for nasopharyngeal carcinoma (NPC) continues to be a challenge. Although nasogastric tube feeding (NGT) has been adopted widely, the weaknesses have yet to be improved by another enteral nutrition support mode. This study aims to observe the clinical efficacy of intermittent oro-esophageal tube feeding (IOE) in the treatment of delayed dysphagia after radiotherapy for (NPC). This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years.
* With the history of NPC and radiation therapy.
* With dysphagia occurred at least three years after radiotherapy
* Conscious and with stable vital signs;
* Willing to participate and sign the written informed consent form either personally or by a family member.

Exclusion Criteria:

* Presence of other diseases that might cause dysphagia.
* With distant metastasis of tumors, or complicated with severe systemic disorders or malignancies.
* Concurrent participation in other treatments that could interfere with the trial.
* Inability to cooperate with treatment due to aphasia, mental health issues, etc.
* Received tube feeding for enteral nutrition support within the past three years.
High- and Low-risk Actinic Keratosis Referrals to Secondary Care

This study evaluates the implementation of the General Practitioners guidelines 'Suspicious Skin Lesions' and investigated whether their publication and implementation has led to a reduction in the proportion of referrals of low-risk patients with actinic keratosis to secondary care, after publication of the General Practitioners guidelines and implementation activities.

In the Dutch healthcare system, patients are first examined by the general practitioner who decides whether a referral to a dermatologist is indicated. Both general practitioners and dermatologists can diagnose and treat patients with actinic keratosis. Therefore, it is necessary to distinguish which patients the general practitioner should refer to a dermatologist and which patients are suitable to be treated by the general practitioner.

This retrospective data study evaluates the proportion of low risk actinic keratosis patients in 2019 en 2018.

Eligibility Criteria:
Inclusion Criteria:

* patients of 18 years and older
* referred to dermatologist for suspicion of actinic keratosis and diagnosed as actinic keratosis by the dermatologist
* treated at MaastrichtUMC+ or TergooiHospital

Exclusion Criteria:

* different diagnosis than actinic keratosis
* referred by a different specialist than the general practitioner
* referred with multiple problems
* referred for a second opinion
* if the patients was treated as different diagnosis than actinic keratosis by general practitioner
Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance

The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering post-meal blood glucose levels in people with pre-diabetes who have high blood sugar levels after meals.


Eligibility Criteria:
Inclusion Criteria:

* Blood glucose criteria must be met
* Body mass index (BMI) in the range 23-45

Exclusion Criteria:

* Diagnosis of diabetes
* Serious cardiovascular events within the past 6 months
* Use of insulin or any oral antidiabetic agent
* Other protocol-defined exclusion criteria may apply
Special Drug Use Investigation for ROTARIX®

This study aims to determine the incidence of intussusceptions (IS) (including suspected cases of intussusception) after vaccination with Oral Rotarix® under clinical practice, in Japan.

This is non-interventional study conducted in one group received Oral Rotarix®.

Eligibility Criteria:
Inclusion Criteria:

* Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis, an indication of Rotarix, will be included in the investigation.

Exclusion Criteria:

* All infants included in the drug use investigation of Oral Rotarix will be excluded.
New Technology for Individualised, Intensive Training of Gait After Stroke- Study II

The overall purpose of this project is to establish the added value of training with the Hybrid Assistive Limb (HAL) exoskeleton system as part of regular rehabilitation intervention programs after stroke.

The main specific aims are:

(i) to compare potential effects on functioning and disability of gait and mobility training long-term after stroke by comparing A) HAL-training combined with conventional rehabilitation interventions to B) conventional rehabilitation interventions without HAL and to C) no intervention.

The effectiveness of the interventions will be assessed in terms aspects of body function, walking ability and endurance as well as level of activity in daily living and participation assessed at the end of intervention and at a 6 and 12 months follow-up.

Intensive gait training with HAL is performed 1 session/day, 3 days/week for 6 weeks and each session will not exceed 60 min of effective walking time with HAL. In addition, each session will include conventional gait training that will not exceed 30 min effective training time. To standardize the training procedure, training with HAL is performed on a treadmill and to enable body weight support. Body weight support is used to prevent falls and to unburden the weight of the suit (9 kg). The training program is performed by physiotherapists, trained in the HAL method and the study procedures. At the end of the 6 weeks, the physiotherapist that has been engaged in the patient's conventional training will perform 1-2 home visits to inform/educate the patient and those who are providing assistance to the patient in how the patient can make use of any gains in gait function during activities of daily living.

The 1st control group will receive conventional gait training performed 1 session/day, 3 days/week for 6 weeks that will not exceed 1h 30 min effective training time.

The 2nd control group will not receive an intervention. The conventional gait training is performed according to current best evidence based practice and may include over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support and training of gait function in activities of daily living

Eligibility Criteria:
Inclusion Criteria:

* 1-10 years since stroke onset
* Able to walk but not independently, i.e. need of manual support or close supervision due to lower extremity paresis, FAC score 2-3 or FAC 4 combined with gait speed \<0.8m/s according to 10 meter walk test, which corresponds to limitations in community ambulation (Bowden et al 2008)
* Ability to understand training instructions as well as written and oral study information and to express informed consent or by proxy
* Body size compatible with the HAL suit.

Exclusion Criteria:

* Contracture restricting gait movements at any lower limb joint
* Cardiovascular or other somatic condition incompatible with intensive gait training
* Severe, contagious infections (e.g. Methicillin Resistant Staphylococcus Aureus (MRSA) or Extended Spectrum Beta Lactamase bacteria).