cyrilzakka/clinical-trials huggingface dataset:
The Impact of Virtual Reality on the Emotional State of Patients With Aphasia During Rehabilitation.

The aim of the study is to determine virtual reality (VR) impact during standard program of rehabilitation on emotional state of patients with aphasia.

Aim 1: To test the safety of virtual reality in a vulnerable population of patients with aphasia during rehabilitation. Participants will be alternately assigned to receiving a relaxation session in VR every working day during a standard course of rehabilitation.

Aim 2: To test the preliminary efficacy of combining VR with the course of rehabilitation to promote emotional improvements in patients with aphasia.

Eligibility Criteria:
Inclusion Criteria:

* Mild or moderate aphasia of any type
* Russian is primary language
* At least 2 weeks post cardio-vascular accident (ischemic or hemorrhagic stroke) or head injury of any location
* Have a history of only one stroke
* Medically stable

Exclusion Criteria:

* Associated severe cognitive deficits and psychiatric disorders which prevent patients understanding of the informed consent
* Epilepsy
* Medical history of severe visual or hearing impairment
* Comorbid neurological diagnosis (e.g. epilepsy, multiple sclerosis, Parkinson disease, dementia)
* Unable to perform the required exercises due to severe motor, sensory or cognitive deficit (memory, attention, executive functioning, apraxia, regulatory and planning activities etc.) and medical problems (for example, anyone meeting New York Heart Association Class IV criteria, hospitalization for myocardial infarction or heart surgery within 120 days, severe cardiomyopathy or documented serious and unstable cardiac arrhythmias)
* Drug or alcohol addiction within the last 6 months.
* Significant current psychiatric illness defined as affective disorder unresponsive to medication or bipolar affective disorder, psychosis, schizophrenia or suicidality
* Current participation in another interventional trial
ICU Nutrition Study Bern

Nutritional treatment has become an essential component of the management of critically ill, due to better knowledge about positive impact of nutritional support. Malnutrition among ICU patients is associated with increased morbidity, mortality, length of stay (LOS) and therefore higher costs.Several studies however suggest, that early implementation of nutritional support is associated with improved clinical outcome, shorter LOS, and decreased infection rates. One of the objectives of this study is to determine if an nutrition protocol can improve the delivery of enteral tube feeding in the ICU.


Eligibility Criteria:
Exclusion Criteria:

* \<18 years of age
* stay less than 72 hours on ICU
* die within 72h after admission
* patients admitted for palliative care
The Prevalence of Prediabetes in Primary Care Medicine in Tunisia

The study is national, observational and cross-sectional and aims to estimate the prevalence of prediabetes in primary care in Tunisia.

TN-PREDIAB is a Tunisian, descriptive, non-interventional, multicenter and cross-sectional clinical study performed in primary care facilities, of both public and private sectors. The study will screen ambulatory patients for at least 4 months to estimate the prevalence of prediabetes among enrolled subjects.

The objectives of the study are:

* Primary objective: to estimate the overall prevalence of prediabetes among Tunisian population
* Secondary objective:
* Describe the clinical and epidemiological profile of prediabetic subjects
* Describe nutritional factors associated with prediabetes

A Scientific Committee validates the scientific writing, a Steering Committee supervises the clinical operations of the project.

Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation).

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patient consulting in primary care in a public or private structure

Exclusion Criteria:

* Known diabetes
* Concomitant medication that may influence blood sugar (corticosteroids, metformin, GLP1 analogues, SGLT2 inhibitor)
* Severe, acute or chronic comorbidity (end-stage renal failure, severe liver disease, heart failure)
* Severe anemia
* Pregnancy
Prophylactic Dimenhydrinate for Intraoperative Nausea and Vomiting

The purpose of this study will be to determine whether an intravenous dose of dimenhydrinate (also known as Gravol), given before the induction of spinal anesthesia, will decrease the incidence of intraoperative nausea and vomiting in patients undergoing Cesarean delivery.

This medication is commonly given during and after the surgery if required, but it is not known whether a preventative dose will decrease the overall incidence of these side effects.

Nausea and vomiting remain one of the most common complications of Cesarean delivery. The results of this study will show whether or not we can improve our present anesthesia regimen, and improve the satisfaction of patients undergoing Cesarean deliveries, by reducing the incidence of nausea and vomiting. Our current practice is not to use any medication for preventing nausea and vomiting unless required. However, nausea and vomiting come quite fast and unexpectedly during the operation, and most of the time the medication we give does not work fast enough. We are planning to study the anti-nausea medication dimenhydrinate (commonly known as Gravol), which has been safely and widely used during pregnancy, labour and Cesarean deliveries, hoping that its use will decrease the incidence of this unpleasant occurrence.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing elective Cesarean deliveries under spinal anesthesia.
* All patients who gave written informed consent to participate in this study.
* ASA I and II patients.
* Full term normal pregnancy.

Exclusion Criteria:

* All patients who refuse to give written informed consent.
* All patients who claim allergy or hypersensitivity to dimenhydrinate.
* Patients with history of vomiting within 24 hours prior to Cesarean delivery.
* Patients with history of gastrointestinal or psychiatric diseases and morbid obesity
* Patients receiving any of the following drugs within 24 hours before the study: opioids, antiemetics, H2 antagonists, phenothiazine and corticosteroids.
* Patients with severe pregnancy induced hypertension
Patient Self-management and Gene Guided Therapy for Chronic Hepatitis C

This study will explore ways to improve the effectiveness of patient Self Management at a time when genetic test results guide new treatments that will dramatically increase the possibility of cure of the hepatitis C virus.The study will also focus on the interactions between provider and patients and the ways that technical work, adaptive work and adaptive leadership foster patient self-management.This proposed 2 year exploratory mixed-methods 12 longitudinal case study will explore patients' and providers' explanations for how and why they engage in technical work, adaptive work, and adaptive leadership and the ways in which these strategies promote or pose barriers to patients' self-management of Chronic Hepatitis C in the context of the new genetic test results and treatments. Specific aims are to:

1: Examine how technical work, adaptive work and adaptive leadership influence patients' perceptions of their likelihood of cure and how this work relates to self-management during 12 to 24 weeks of treatment for Chronic Hepatitis C. Research questions are: 1.1) How do patients describe their interactions with the providers? 1.2) How do these interactions shape patients' perceptions of the likelihood of cure? 1.3) How do patients' understanding of their interactions with the provider promote the use of or pose barriers to self-management during treatment?

AIM 2: Describe providers' use of technical work, and adaptive leadership approaches during clinical encounters,to include nurse education visits. Research questions are:

2.1) What technical work, and adaptive leadership approaches do providers use when sharing treatment information with patients during the clinical encounters. 2.2) What explanations do providers give for how and why they use technical work and adaptive leadership approaches? AIM 3: Describe the trajectories of illness perceptions(Control/Cure sub-scale - Illness Perception Scale), symptoms (M.D. Anderson Symptom Inventory) , viral load, and self-management (Patient Activation Measure) in relation to patient and provider reports of technical work, adaptive work, and adaptive leadership from the index clinical encounter to the follow-up treatment response encounter (ranging from 12 to 24 weeks).


Eligibility Criteria:
Inclusion Criteria:

* African American or Caucasian
* Genotype 1
* Planning to, but have not yet, began treatment for Hepatitis C at Duke University Medical Center or Boice-Willis Clinic in Rocky Mount, NC

Exclusion Criteria:

* Diagnosed with Bipolar Disorder or Schizophrenia
* Not genotype 1
* Any race other than African American or Caucasian.
* Hispanic or Latino
A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD)

This research study will examine the safety and effectiveness of ONS-5010 in participants with AMD. The goal is to prevent vision loss by evaluating the effectiveness of ONS-5010 as compared with ranibizumab.


Eligibility Criteria:
Inclusion Criteria:

* Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye
* Best corrected visual acuity of 25-67 letters read (20/50 to 20/320 Snellen equivalent)
* Study eye must:

  * Have active leakage on Fluorescein Angiogram involving the fovea
  * Have edema involving the fovea
  * Be free of scarring, fibrosis, or atrophy involving the central foveal zone

Exclusion Criteria:

* Previous subfoveal focal laser photocoagulation in the study eye
* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization
* Any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss within 1 year
* Active intraocular inflammation (grade trace or above) in the study eye
* Current vitreous haemorrhage in the study eye
* Polypoidal choroidal vasculopathy (PCV) in the study eye
* History of idiopathic or autoimmune-associated uveitis in either eye
* Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
* Premenopausal women not using adequate contraception
* Current treatment for active systemic infection
* Known allergy to any component of the study drug or history of allergy to fluorescein , not amenable to treatment
Comparative Study Between Different Approaches to CPA-petroclival Meningiomas

• Give an effective treatment for CPA-petroclival meningiomas and can detect the best approach for these tumors.

. Improve the outcome of these patients and decease rate of recurrence.

There are several lesions arising in the petroclival region. The most frequent tumor is the petroclival meningioma, followed by chondrosarcomas, chordomas, schwannomas of the cranial nerves V and VII, and other malignant tumors \[1, 2, 3, 4, 5\].

Petroclival meningiomas are tumors of the skull base that present a formidable challenge to surgical resection because of their deep location and relationship to vital neurovascular structures. In the majority of the cases they are benign tumors, but may involve or infiltrate the skull base bone, the dura mater, the brainstem, and all important neurovascular structures of this region. The petroclival region comprises the anatomical location of the body of the sphenoid bone, the anterior central portion of the occipital bone, and is bordered on the lateral aspect by the petrous apex. The roof of this space is formed by the petroclival ligaments and the tentorium. This space contains important neurovascular structures that are frequently involved or displaced by the tumor in a variable pattern. The basilar artery with its branches may be embedded or displaced by the meningioma. The petrosal vein is often displaced posteriorly by the tumor. Cranial nerves III and IV are usually displaced upwardly and the nerve VI is often surrounded by tumor. Petroclival meningiomas have their origin medial to cranial nerves V, VII, VIII, IX, X, and XI, and reach the tentorium . They frequently extend to the middle cranial fossa, cavernous sinus, prepontine space, and down to the foramen magnum. These tumors frequently compress the brainstem making total removal very difficult or impossible without neurologic deficits. cerebellopontine angle (CPA) and low clivus meningiomas may reach these areas. These lesions usually need different surgical approaches as transpetrosal approach ( anterior, modified and combined ) and retrosigmoid approach

Eligibility Criteria:
Inclusion Criteria:

* Patient with a single lesion .
* Patient with a denovo lesion.

Exclusion Criteria:

* Patient with recurrent lesions.
* Patient with lesions after adjuvant therapy.
Use of Rainbow Acoustic Monitoring in Pediatric Patients - A Clinical Engineering Data Collection Protocol

The study will capture high resolution waveform data and numerical data from three respiratory rate methods: end tidal CO2, impedance pneumography, and bioacoustic sensing (Rainbow Acoustic Monitoring, RAM).


Eligibility Criteria:
Inclusion Criteria:

* 0 to 18 years old inclusive, male and female patients
* Only patients with written informed consent signed by parents or legal guardians will be enrolled
* In children 10 and older, patient's assent will be obtained

Exclusion Criteria:

* Patients who are unable to give their consent and/or assent
* Patients with skin abnormalities (rash, eczema, etc) at the planned application sites that would interfere with sensor, cannula or electrode applications
A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)

Researchers are looking for new ways to treat non-small cell lung cancer (NSCLC) that is metastatic, which means cancer has spread to other parts of the body.

Some people with metastatic NSCLC are treated with pembrolizumab, an immunotherapy treatment that is given into a vein as an intravenous (IV) infusion. Pembrolizumab (+) Berahyaluronidase alfa is pembrolizumab that is given under the skin as a subcutaneous (SC) injection. The goal of this study is to compare what happens to pembrolizumab in a person's body over time when it is given as an IV infusion or SC injection.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC).
* Measurable disease as assessed by the local site investigator/radiology.

Exclusion Criteria:

* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
* Received prior systemic anticancer therapy for their metastatic NSCLC.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Active autoimmune disease that has required systemic treatment in the past 2 years.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Active infection requiring systemic therapy.
STARZ-TX2 Clinical Study: Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft

The STARZ-TX2 trial (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2(R) TAA \[Thoracic Aortic Aneurysm\] Endovascular Graft) is a clinical trial approved by the United States Food and Drug Administration (FDA) to study the safety and effectiveness of the Zenith TX2 TAA Endovascular Graft in the treatment of thoracic aortic aneurysms / ulcers.

The STARZ-TX2 trial (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2(R) TAA Endovascular Graft) is a clinical trial approved by the FDA to study the safety and effectiveness of the Zenith TX2(R) TAA Endovascular Graft in the treatment of thoracic aortic aneurysms / ulcers. Instead of making a large incision in the chest, the physician makes a small incision near the groin to insert and guide the graft into place in the aorta, relieving pressure on the aneurysm and helping to reduce the risk of rupture.

The Zenith TX2 TAA Endovascular Graft is a reinforced fabric tube that is sized to the length of the aorta that needs to be covered to seal off the aneurysm / ulcer. The graft is made of a polyester material like that used in open surgical repair. Standard surgical suture is used to sew the graft material to a frame of self-expanding stainless steel stents, which provide support. The materials used in the Zenith TX2 system have a long history of use in medical implants.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with aneurysms / ulcers of the descending thoracic aorta
* Patients who are candidates for either surgery or endovascular repair
* Patients at least 18 years old

Exclusion Criteria:

* Age \< 18 years
* Patients with other medical condition (e.g., cancer, congestive heart failure) that may cause non-compliance with the protocol, confound the results, or with limited life expectancy (i.e., less than 2 years)
* Patients pregnant, breast-feeding, or planning on becoming pregnant within 24 months
* Patients unwilling or unable to comply with the follow-up schedule
* Patients unable or who refuse to give informed consent
* Patients simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)
Study of CM313(SC) Injection in Subjects With Platelet Transfusion Refractoriness

This is a randomized, open-label, phase IB/II clinical study to evaluate the safety and preliminary efficacy of CM313(SC) injection in patients with Platelet Transfusion Refractoriness.


Eligibility Criteria:
Inclusion Criteria:

1. Thrombocytopenia dependent on platelet transfusions and diagnosed with platelet transfusion refractoriness.
2. Presence of one or more kinds of antiplatelet antibodies.
3. Male or female, age≥18 years.
4. The Eastern Cooperative Oncology Group (ECOG) physical status score ≤2.
5. Willing and able to comply with the requirements for this study and written informed consent.

Exclusion Criteria:

1. Diagnosed with Idiopathic thrombocytopenic purpura.
2. Platelet transfusion refractoriness caused by non-immune factors.
3. Previously treated with the anti-CD38 monoclonal antibody.
4. Have an allergy to humanized monoclonal antibody or any part of CM313.
5. Pregnant or breastfeeding females, or females planning to become pregnant during the study.
6. Any condition considered to be ineligible for the study by the investigator.
Oral Nitrite Trial for Hypertension and Metabolic Syndrome

The objective of the study is to investigate effects of inorganic sodium nitrite on the cardiometabolic and hormonal disturbances observed in a targeted population of overweight/obese adults with metabolic syndrome and hypertension, at risk for insulin resistance and endothelial dysfunction.

Cardiovascular disease remains the leading cause of death in the United States and worldwide. Several studies have demonstrated that fruit and vegetable rich diets significantly reduced blood pressure and reduced the risk of ischemic stroke and cardiovascular disease in general, the exact mechanisms remain poorly understood. Preclinical and clinical research over the last decade has revealed the important vasoprotective effects of nitrates and nitrites with regards to reduction in blood pressure, vascular inflammation and endothelial dysfunction. More recent findings suggest that inorganic nitrate and nitrite therapy may be involved in the regulation of glucose-insulin homeostasis.

For this reason, development of an oral formulation of nitrite salt represents a rational avenue of exploration for the treatment of cardiovascular diseases, whereby nitrite would ensure rapid acting effects upon absorption. Nitrite could then be oxidized to nitrate via the enterosalivary circulation pathway. In this pathway, about 25% of circulating nitrate is concentrated in the saliva and reduced to nitrite by commensal mouth bacteria with nitrate reductase enzymes. The proposal will investigate the inorganic nitrite effects (in any form) on insulin sensitivity in a targeted population of overweight/obese adults with metabolic syndrome and hypertension, at risk for insulin resistance and endothelial dysfunction. This will be the third human trial using orally delivered nitrite (previously as aqueous solution).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years
* Body mass index (BMI) ≥ 30 kg/m2
* Hypertension: defined as systolic blood pressure ≥130 and/or diastolic blood pressure ≥85 mm Hg
* Waist circumference: \>102 cm in men, \>88 cm in women

Exclusion Criteria:

* Positive urine pregnancy test or breastfeeding
* Concurrent use of medications affecting glucose metabolism (oral hypoglycemics, insulin, atypical antipsychotics)
* Recent addition or change in dosing of hormonal contraceptive medications (Oral Contraceptive Pill (OCP), Intra Uterine Device (IUD), DepoProvera shot)
* Current use of ≥3 anti-hypertensive agents regardless of blood pressure control or normotensive on a single or double agent
* Current use of phosphodiesterase-5 (PD) inhibitors or organic nitrates. We will not exclude for dietary sources of nitrate/nitrite.
* Not stable on treatments for the prior three months or not planning to remain on current dose of medications for blood pressure, contraception, etc.
* Known chronic psychiatric or medical conditions including diabetes, liver or kidney disease or obesity syndromes
* Thyroid Stimulating Hormone (TSH) \>8 milli-International unit/mL
* Smoker
* Anemia (central lab hemoglobin \< 11g/dL)
* Active periodontal disease