cyrilzakka/clinical-trials huggingface dataset:
Effects of Gastrostomy and Oral Tube Feeding on Patients With Dysphagia After Stroke

The goal of this clinical trial is to compare the differences in swallowing function, quality of life and nutritional status between ischemic stroke patients with dysphagia using Intermittent Oro-esophageal Tube and Gastrostomy. Patients will be randomly divided into an oral tube group and a Gastrostomy group, all receiving routine rehabilitation treatment. On this basis, the oral tube group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the Gastrostomy group will use Gastrostomy. Researchers will compare changes in swallowing function, quality of life and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the quality of life and nutritional status between ischemic stroke patients compared Gastrostomy.

This study will last 15 days for each patient. The goal of this clinical trial is to compare the differences in swallowing function, quality of life and nutritional status between ischemic stroke patients with dysphagia using Intermittent Oro-esophageal Tube and Gastrostomy. Patients will be randomly divided into an oral tube group and a Gastrostomy group, all receiving routine rehabilitation treatment. On this basis, the oral tube group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the Gastrostomy group will use Gastrostomy. Researchers will compare changes in swallowing function, quality of life and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the quality of life and nutritional status between ischemic stroke patients compared Gastrostomy.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years.
* Meeting the diagnostic criteria for ischemic stroke .
* Dysphagia confirmed by Videofluoroscopic Swallowing Study.
* Clear consciousness.
* No history of prior stroke.
* Stable vital signs.

Exclusion Criteria:

* Use of tracheostomy tubes.
* Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
* Pregnant or nursing females.
Liver Enzymes and Fluid Balance Following Colorectal Surgery

The use of epidural anesthesia and postoperative analgesia influences fluid balance following colorectal surgery.

Markers such as BNP (brain natriuretic peptide) and liver function enzymes can estimate intravascular fluid load and predict outcome after colorectal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing colorectal surgery

Exclusion Criteria:

* Severe cardiac failure Severe renal failure Severe liver failure
At-Home taVNS - Stroke Rehab

Early evidence suggests the benefits of post-stroke motor rehabilitation may be enhanced by applying electrical stimulation to the ear. This study aims to test the new approach of pairing ear stimulation with motor rehabilitation in the home setting in stroke survivors with upper limb motor function deficits.

This study seeks to advance prior research conducted here at MUSC exploring the use of transcutaneous auricular vagus nerve stimulation (taVNS) paired with motor rehabilitation to improve motor function post-stroke. Early evidence from a recently completed NIH-funded, clinical trial suggests that our new approach of delivering electrical stimulation to the ear at the same time as motor rehabilitation double the clinical benefits of motor rehabilitation. These benefits are due in part to a facilitation of neuroplasticity caused by activating the auricular branch of the vagus nerve.

This project takes this approach one step further, moving it into the home in combination with telerehabilitation in order to make this technology more accessible to individuals in rural and remote areas. In order to accomplish this, investigators will a) conduct lab-based testing and validation of the stimulation triggering sensors for at-home use, and b) determine the safety, feasibility, and acceptability of at-home taVNS in five stroke survivors with unilateral upper limb motor deficits.

Investigators hypothesize that our lab-based validation will facilitate an optimized home intervention. Furthermore, investigators hypothesize taVNS will be safe and feasible to self-administer in the at-home setting. Lastly, investigation will help elucidate any challenges that may occur as investigators begin to expand this technology into future larger trials

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old with an ischemic or hemorrhagic stroke that occurred ≥6 months prior;
* Ability to give consent;
* Unilateral limb (left or right) weakness with Fugl Meyer-Upper Extremity Scale score of 19-53/60 points which indicates adequate arm/hand use for rehabilitation tasks;
* active wrist flexion/extension ≥10° with active abduction/extension of thumb and at least 1 digit ≥10° to further assure ability to participate in rehabilitation tasks;
* Passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal values.

Exclusion Criteria:

* Other concomitant neurological disorders affecting upper extremity motor function;
* Presence of Dysphagia or aspiration difficulties;
* Prior injury to vagus nerve;
* Pregnancy;
* Documented history of dementia before or after stroke;
* Documented history of uncontrolled depression or psychiatric disorder either before or after stroke which could affect their ability to participate in the experiment;
* Uncontrolled hypertension;
* Botox injections within 4 weeks of the first day of rehabilitation therapy.
Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients

Using mechanical ventilation for more than 18 hours can affect respiratory muscle and postural muscle control, making it difficult to wean off the ventilator and reducing mobility. The aim of this study is to:

1. Compare the effects of respiratory muscle strength training and early mobilization on dynamic lung compliance and maximum inspiratory pressure before and after a 7-day training period.
2. Compare the success rate of weaning and the duration of weaning between the respiratory muscle strength training and the early mobilization program.

The prolonged mechanical ventilation results in difficulty weaning off the ventilator. Inspiratory muscle strength and early mobilization can contribute to the expansion of lung parenchyma and facilitate success in weaning off respiratory support. Thus, this study aimed to explain the impact of inspiratory muscle training and early mobilization on dynamic lung compliance, spontaneous breathing time, and success rate in patients who have undergone mechanical ventilation for more than 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* Patients with respiratory diseases who have been on mechanical ventilation for more than 48 hours and are ready to be weaned off or undergoing weaning trials with continuous positive airway pressure (CPAP) or synchronized intermittent mandatory ventilation (SIMV).
* The PaO2/FiO2 ratio is ≥ 150-200, with FiO2 ≤ 0.4-0.5 and PEEP ≤ 5-8 cmH2O, and a pH \&gt; 7.3 in blood plasma.
* The age range is between 40 and 80 years old.
* Patients exhibit good self-awareness and cooperation in training (Riker score of 4).
* They can understand and communicate in Thai

Exclusion Criteria:

* Clinical instability (HR \&gt; 120 beats/minute, RR \&gt; 30 breaths/minute, SatO2 \&lt; 90%, SBP \&gt; 140 mmHg or \&lt; 90 mmHg)
* Patients who can be extubated and use non-invasive ventilation only or successfully extubated within the first 24 hours.
* Patients with altered mental status (Glasgow Coma Score \&lt; 10) and inability to cooperate with training (Riker score \&lt; 4 or \&gt; 4)
* Patients with limitations or contraindications such as inability to adjust the bed to a 45-degree angle or sit on the side of the bed, such as those with spinal cord injuries or recent head surgeries.
* History of hemoptysis, pneumothorax
* History of neuromuscular diseases causing muscle weakness and decreased sensation.
* Patients with excessive cardiac stimulation (\&gt; 5 micrograms per kilogram per minute)
* Heart rate \&gt; 140 beats per minute
* Hemoglobin levels \&lt; 8-10 grams per deciliter
* Patients with difficult airway issues.
Cardiac Surgery: In Vivo Titration of Protamine

Safe use of cardiopulmonary bypass (CPB) requires massive doses of intravenous unfractionated heparin. At end-CPB, residual heparin is neutralized with intravenous injection of protamine sulfate. This prospective, randomized, controlled study will be conducted in 82 voluntary subjects admitted for elective, first intention, cardiac surgery requiring cardiopulmonary bypass. Each will be randomly assigned to one of two groups. The control group will be submitted to a standard protamine infusion of 1.3mg :100U of the total heparin dose given during bypass. The test group will receive an infusion of protamine (over 15 minutes) until activated clotting time (ACT) values (determined every 3 minutes) depict a plateau, sign that the optimal protamine to heparin ratio has been attained. The investigators hypothesize this new in vivo titration method to be as efficient as the standard protocol (adequacy of heparin neutralization, % heparin rebound, bleeding, and transfusion), and potentially safer by its ability to prevent protamine overdose and its deleterious impact on platelet function.15

Principal Objective

Evaluate a new in vivo method of titration of protamine sulfate.

Secondary Objective

Evaluate the impact of this method on the adequacy of heparin neutralization by measuring:

1. platelet count
2. postoperative bleeding
3. transfusion exposure a
4. incidence of heparin rebound

Protamine sulfate is administered to reverse the anticoagulant effects of heparin upon completion of cardiopulmonary bypass (CPB). In most cases, protamine is given in amounts sufficient to neutralize the total dose of heparin.9 This dose is usually calculated with a ratio of 1.3mg protamine for every 100U heparin given.10 In the literature, reported doses of intraoperatively administered protamine range from 0 to 8mg per 100U of heparin. Given in excess, protamine can, in addition to complement activation and hemodynamic instability,11 induce platelet dysfunctions.12-16 The latter significantly increases both the cost and morbidity of cardiac interventions as it is one of the main causes of postoperative bleeding. The optimal protamine/heparin ratio is difficult to individualize for each patient because of the great interpatient variability in heparin's metabolism4-7 and of the absence of correlation between ACT and heparin's plasma concentration.8 Consumption of heparin may vary from 0.01 to 3.86U/Kg per minute during CPB.30 The exact concentration of remaining circulating heparin at the end of bypass is not easily obtained.

Eligibility Criteria:
Inclusion Criteria:

* First intention, elective, cardiac surgery: either Coronary Artery Bypass Graft (CABG)or valve repair/replacement.
* Patients on preoperative aspirin, clopidogrel or heparin will be included.

Exclusion Criteria:

* Combination of CABG and valve surgery
* Second intention cardiac surgery
* ASA 5 patients
* Pre-existing hemostatic disorder (as evidenced by history)
* Pregnancy
* PLavix \< 5 days before de surgery
Safety Study of the Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access

The purpose of this study is to determine whether the long term use of the experimental Vascular Wrap(TM) Paclitaxel-Eluting Mesh is safe in the treatment of subjects needing hemodialysis access (via an expanded polytetrafluoroethylene (ePTFE) graft).

The primary objective of this study is to determine long term safety of the Lifespan® ePTFE Vascular Graft and Vascular Wrap(TM) Paclitaxel-Eluting Mesh in comparison to the Lifespan® graft alone.

Eligibility Criteria:
Inclusion Criteria: To be considered for enrollment, subjects must:

* have been randomized in protocol 012-VWAV06;
* have signed and dated an IRB-approved written informed consent to participate in 012-VWAV06 as well as this study;
* be willing to comply with all aspects of the evaluation schedule over a period of 60 months post device insertion;
* allow representatives of the sponsor, designated Clinical Research Organization (CRO), Institutional Review Board (IRB), the Ethics Committee, and U.S. Food and Drug Administration (FDA) to review his/her relevant medical records.

Exclusion Criteria:

* Subjects who withdrew or were withdrawn from study 012-VWAV06.
Microvascular Coronary Resistance and Absolute Coronary FLOW in Patients With Percutaneous Intervention of a Chronic Total Occlusion

It is an observational study which objective is to analyze, through a series of invasive parameters, the state of the coronary microvasculature immediately after the successful percutaneous coronary intervention of a chronic total occlusion and at 6 months after the index procedure.

The aim of the study is to check the variation in the values of the index of microcirculatory resistance (IMR) and invasive absolute coronary flow (AF). The working hypothesis is that, in the follow-up of these patients, AF will increase significantly with respect to its baseline and, conversely, IMR will be reduced during the follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Those patients with a clinical indication for percutaneous coronary intervention of a chronic total occlusion. As a routine clinical practice in our center, it is proposed to perform a angiographic follow-up 6 months after the index procedure.

Exclusion Criteria:

* No specific exclusion criteria.
Follow-Up Study of Patients Previously Treated With Pimecrolimus Tablets for Atopic Dermatitis

This extension study is being conducted to collect post-treatment safety information on patients who previously participated in the core clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Consenting patients who participated in the core clinical trial
PROSTVAC®-VF/TRICOM™ Vaccine for the Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy

PROSTVAC-VF is an investigational cancer vaccine. The vaccine is based on the theory that the immune system can be taught to fight cancer by directing the immune system to attack specific targets found on cancer cells. These targets are called Tumor Associated Antigens, or TAA's. This trial will help determine if this vaccine can help fight cancer.

This multi-center, double-blind, randomized, empty vector-controlled trial is designed to evaluate the safety and efficacy of PROSTVAC-VF/TRICOM co-administered with GM-CSF versus the empty viral vector co-administered with placebo in the treatment of patients with androgen-independent prostate cancer (AIPC).

All patients will be required to sign an informed consent prior to the performance of any on-study procedures. Patients will be screened for eligibility within 14 days prior to vaccine administration. Patients who meet all inclusion and exclusion criteria will be centrally randomized into the study and will receive a unique patient identification number and a blinded treatment assignment. The ratio of active treatment to empty vector control (placebo) is 2:1.


Eligibility Criteria:
* Male patients \> 18 years of age who have been vaccinated against smallpox;
* Histological confirmation of adenocarcinoma of the prostate with evidence of metastatic disease including either of the following: Lymph node metastasis measurable by CT and/or Bone metastasis evaluable by bone scan;
* Despite hormone therapy, there is evidence of two consecutive increases in PSA (Prostate Specific Antigen);
* Gleason Score of 7 or lower at initial diagnosis.

Please note that there are additional eligibility criteria that you must meet to qualify.

If you do qualify to participate, study personnel will explain the trial in detail and answer any questions you may have. You can then decide whether or not you wish to participate. If you do not qualify for the trial, study personnel will explain the reasons.
Natural History of Sickle Cell Disease

This study is not a treatment protocol and no experimental treatments are involved. Study participants may be seen as needed for clinical, translational and basic research studies, or as medically indicated. Subjects will receive their general medical care outside the NIH and will be seen at our clinic or at CNHS with varying frequency. Subjects may be seen for multiple visits. Subjects may be asked to return for additional testing as needed. Clinical care for patients with sickle cell disease will be provided as appropriate through the Sickle Cell Clinic and the inpatient clinical center.

This protocol will permit the establishment of a repository of biospecimens from individuals affected with sickle cell disease to identify and evaluate underlying disease mechanism(s), and to facilitate understanding of the pathogenesis and natural history of vaso-occlusive painful crisis and other complications of the disease. Patients will be evaluated with a medical history and physical examination and routine laboratory studies will be obtained as needed to assess diagnosis, disease activity, and disease complications and to monitor for treatment-related responses and toxicities. This protocol may also provide for the continued storage and analysis of clinical and research data, and biospecimens previously obtained from other NIH Institutional Review Board (IRB)-approved protocols with subject consent.

Patients eligible for other research protocols will be offered an opportunity to participate in these studies after signed informed consent has been obtained. Apart from such protocols, any medical care or additional tests/investigations recommended or provided to the patient will be consistent with routine standards of practice and will be provided in consultation with the patient s referring physician.

Eligibility Criteria:
* INCLUSION CRITERIA:
* Individuals with known or suspected sickle cell disease
* 2 years of age and older
* Willing to provide informed consent or appropriate informed consent from parent or legal guardian
* Patients seen at sickle outpatient clinics at any one of the participating centers (CNHS or NIH).

EXCLUSION CRITERIA:

* Patient and/or guardian unable and unwilling to give informed consent or assent.
* Patients less than 2 years of age.
Efficacy and Safety of hzVSF-v13 in Patients With COVID-19 Pneumonia

Preliminarily investigate the safety and efficacy of two doses of hzVSF-v13 + SOC vs. placebo + SOC for the treatment of COVID-19 pneumonia.

Proof of concept, multicentre, randomized, parallel-group, double-blind, placebo-controlled

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent from any patient capable of giving consent, or, when the patient is incapable of doing so, by his or her legal/authorized representative. Note: In accordance with the European Medicines Agency (EMA) "Guidance on the management of clinical trials during the covid-19 (coronavirus) pandemic version 3 28/04/2020", if written consent by the trial participant is not possible (for example because of physical isolation due to COVID-19 infection), consent may be given orally by the trial participant in the presence of an impartial witness.
2. Age 18 years or older.
3. Patient is currently hospitalized.
4. Diagnosis of COVID-19 pneumonia including a positive RT-PCR test for SARS-CoV-2 of any specimen and lung involvement confirmed with chest imaging (X-ray or computed tomography \[CT\] scan).
5. Able to comply with the study protocol.
6. Female patients must be postmenopausal (24 months of amenorrhea), surgically sterile or must agree to use an effective method of contraception throughout the study and for up to 120 days after stopping treatment. Effective contraception includes an established hormonal therapy or intrauterine device for females, and the use of a barrier contraceptive (i.e. diaphragm or condoms) with spermicide.

Exclusion Criteria:

1. Patients with known or suspected hypersensitivity to hzVSF-v13 or to any of its excipients.
2. Active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides COVID-19).
3. Anti-rejection or immunomodulatory drugs within the past 3 months.
4. Absolute neutrophil count (ANC) \< 1000/µL at screening.
5. Platelet count \< 50,000/ µL at screening.
6. ALT or AST \> 5 x upper limit of normal (ULN) within 24 hours at screening.
7. Serum creatinine \> 2 mg/dL (\> 176.8 μmol/L) or estimated creatinine clearance \< 30 ml/min measured or calculated by Cockroft Gault equation.
8. Pregnancy or breastfeeding.
9. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (approved/investigational COVID-19 antivirals and other off-label drugs recommended by local health authorities are permitted).
10. Patients who in the opinion of the treating physician should not participate in this program (ex: severe acute respiratory distress syndrome \[ARDS\], septicaemia).
Comparison Between Clear Aligners and Traditional Fixed Appliances in the Treatment of Four-premolar-extraction Cases

Patients who have severe crowding that require four premolars extraction will be treated in this study. The efficacy of the clear aligners and vestibular fixed appliances will be assessed. The treatment result of these two different methods will be explored using the Peer Assessment Rating (PAR) in two different times (T0: Before treatment, T1: After treatment) and the American Board of Orthodontics Objective Grading System (ABO-OGS) after treatment (T1).

There are two groups:

First group (Experimental): the patients in this group will be treated using clear aligners.

Second group (Control): the patients in this group will be treated using fixed appliances.

For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the CAD/CAM technology, clear aligners treat a broader range of cases with greater precision. They consist of a series of plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved.

Eligibility Criteria:
Inclusion Criteria:

* Class I malocclusion with severe crowding (more than 5 mm of tooth-size-arch-length-discrepancy).
* Good oral hygiene and periodontal health.
* No severe skeletal discrepancy.
* Normal proclination for the upper and lower incisors.
* No congenitally missing or extracted teeth (except for the third molars).
* No history of previous trauma to the maxillofacial region or surgical interventions.

Exclusion Criteria:

* Bimaxillary dentoalveolar severe protrusion.
* Previous orthodontic treatment.
* Subject with psychological abnormalities.
* Subject with systemic diseases.
* Subject has known allergy to latex and plastic