cyrilzakka/clinical-trials huggingface dataset:
Health-related Quality of Life in Adults After Veno-arterial Extra-Corporeal Membrane Oxygenation Which is a Salvage Therapy Used in Patients With Severe Respiratory or Cardiac Failure Who Have Not Responded to Maximal Conventional Medical Therapy

Extracorporeal Membrane Oxygenation (ECMO) is a salvage therapy used in patients with refractory cardiogenic shock. This rescue technique is associated to a high mortality rate and to many complications that can impact the quality of life of the survivors. The aim of this study is to evaluate the Health-related quality of life in adults after veino-arterial Extra-Corporeal Membrane Oxygenation. The quality of life will be evaluated thanks to several methods : the Short Form 36, the EQ 5D 5L and the return to work status.

Then, the investigators will analyze by subgroup the quality of life according to the cardiogenic shock etiology and try to determine the risk factors of an altered quality of life. The investigators will also evaluate current comorbidities of the patient thanks to the Groll Index.


Eligibility Criteria:
Inclusion Criteria:

* Adults \>18 years
* Veno-arterial ECMO between April 2008 and December 2019 in NHC surgical intensive care of Strasbourg
* Affiliated to the French social security system

Exclusion Criteria:

- Patients under guardianship or with legal protection
Salt and Gut Study

High sodium intake is a significant risk factor for hypertension. Recently, animal studies connect high sodium intake to the gut-immune axis and highlight the gut microbiome as a potential therapeutic target to counteract salt-sensitive conditions and hypertension. The objective of this project is to determine the effects of high salt intake on gut microbiota composition and gut intestine barrier integrity, leading to increased BP in humans. The investigators also hypothesize that high salt intake affects the gut microbiome in a sex-specific manner. In this pilot study, The investigators also test whether telehealth or in-person nutritional coaching help to decrease dietary sodium intake and improve diet quality

The investigators will conduct a randomized, double-blind, placebo-controlled trial in normotensive and stage 1 hypertensive drug naïve participants (age 18-50 years, equal distribution of blacks and whites, and males and females, BP \<140/90 mmHg). The average intake of sodium in the American diet is 3,400 mg per day. The average recommended dose is 2,300 mg per day. Eligible participants will be enrolled and provided with one-hour in-person/telehealth nutritional counseling at the GPI to reduce their sodium intake by 1,100 mg per day to achieve the sodium intake of 2,300 mg/day. Participants will then be randomized to receive either placebo or salt pills of 2,000 mg per day for four weeks while continuously receiving weekly telehealth nutritional counseling. The salt group's sodium intake will be 4,300 mg per day, while the sodium intake in the placebo group will be 2,300 mg per day. Participants will have a follow-up visit at six months after the 4-week sodium intervention. Participants will be tested four times (Figure 1). Participants will receive the first 1-hour in-person/telehealth nutrition counseling at GPI (baseline) and three weekly telehealth nutrition counseling during the 4-week intervention period.

Eligibility Criteria:
Inclusion criteria:

* Aged between 18-50 years
* African Americans (AAs) or European Americans (EAs)
* BP \<140/90 mmHg
* Not on any prescription medications
* Normal kidney function (eGFR ≥ 90 ml/min/1.73 m2)

Exclusion criteria:

* Pregnant or nursing
* Previous diagnosis of major cardiovascular diseases including myocardial infarction, congestive heart failure or stroke, diabetes, autoimmune, chronic liver and kidney disease
* Previous diagnosis of Crohn's disease or any other intestinal conditions
* Previous diagnosis of major lung diseases such as chronic obstructive pulmonary disease (COPD)
* Previous diagnosis of cancer
* Alcohol and drug abuse.
Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors.

This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive solid tumors. The study has a basket design and includes several cohorts, either defined by an actionable somatic mutation or by actionable mutation and tumor histology, including HER2 mutant breast, HER2 mutant cervical, HER2 mutant salivary gland, and EGFR Exon 18 mutant Non-small cell lung cancers.

The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 days after the last dose of neratinib and a survival follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent
* Histologically confirmed cancers for which no curative therapy exists
* Documented HER2 or EGFR exon 18 mutation
* Participants must agree and commit to use appropriate methods of contraception as outlined in the protocol
* At least one measurable lesion, defined by RECIST v1.1

Exclusion Criteria:

* Participants harboring ineligible somatic HER2 mutations
* Prior treatment with any HER2-directed tyrosine kinase inhibitor (e.g., lapatinib, afatinib, dacomitinib, neratinib) is excluded with the following exception: patients with EGFR exon 18 mutated NSCLC who may have received afatinib, osimertinib, or other pan HER or EGFR TKIs remain eligible
* Participants who are receiving any other anticancer agents
* Symptomatic or unstable brain metastases
* Women who are pregnant or breast-feeding

There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.
A Multi-centre, Double-blinded, Randomized, Placebo-controlled Trial on the Efficacy and Safety of Lopinavir / Ritonavir Plus Ribavirin in the Treatment of Severe Acute Respiratory Syndrome

The study aims to examine whether the combination of Lopinavir/Ritonavir plus Ribavirin for treatment of severe acute respiratory syndrome (SARS) is superior to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male or female over the age of 18 with a diagnosis of SARS and with valid consent will be recruited.

Exclusion Criteria:

* Subjects with medical conditions that makes the prescription of study medications unsafe are excluded.
Coronary Screening in a High Risk Subset

To test the hypothesis that the incidence of coronary heart disease and cardiovascular mortality could be accurately predicted by the presence of coronary calcific deposits detected by cardiac fluoroscopy.

BACKGROUND:

Because of its low cost and non-invasive nature, fluoroscopy was thought to be a potentially powerful screening tool for coronary heart disease if its efficiency could be demonstrated. The utility of exercise testing for screening had been limited by its relatively low sensitivity since it could only detect atherosclerotic plaque large enough to significantly impede coronary flow.

DESIGN NARRATIVE:

Asymptomatic high risk subjects were screened with cardiac fluoroscopy and exercise testing at baseline and followed for six years with annual visits. The sensitivity and specificity of fluoroscopy in relation to the incidence of coronary heart disease and the incidence of cardiovascular mortality was determined and compared at 3.5 and 6 years of follow-up. The predictive utility of fluoroscopy and exercise testing, in relation to the incidence of coronary events, was assessed by logistic regression analysis. Multivariate analysis was also performed on baseline risk factors.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
A Study To See If GSK256073A Can Block Niacin-Induced Flushing In Healthy Volunteers

To test the ability of GSK256073 to block niacin-induced flushing when GSK256073 and niacin are co-administered as single doses to HVTs.


Eligibility Criteria:
Inclusion Criteria:

* Adult males between 18 and 55 years of age, inclusive.
* Healthy subjects
* Body weight \> 50 kg (110 pounds) and body mass index (BMI) between 19 and 31 where:
* Subjects with QTc \< 450 msec at screening

Exclusion Criteria:

* History of significant cardiac arrhythmias
* Active peptic ulcer disease (PUD) and/or history of PUD
* History of gout and/or hyperuricemia
* History of Gilbert's syndrome
* History of recurrent indigestion, stomach upset or diarrhea
* History of other than rare (once yearly or less) flushing
* Recurrent skin rash or psoriasis
* History of kidney stones
Dose-finding Trial of HCD122 in Patients With Chronic Lymphocytic Leukemia (CLL) That is Relapsed or Non-responsive to Prior Fludaribine Therapy

The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with chronic lymphocytic leukemia who are relapsed after receiving prior treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of CLL requiring treatment
* Refractory or relapsed disease
* Prior treatment with fludarabine
* Male or Female
* \>18 years of age

Exclusion Criteria:

* Treatment with rituximab within 90 days and alemtuzumab or any monoclonal antibody within 6 months.
* Clinically significant cardiac dysfunction or other significant organ dysfunction

Additional eligibility criteria apply that will be reviewed with potential study subjects at the site.
The Effects of WBV on Muscle Stiffness and Reflex Activity in Stroke.

Spastic hypertonia is common after stroke. Whole-body vibration (WBV) is known to have modulatory effects of muscle reflex activity and blood flow in other populations and thus have potential applications in the management of spastic hypertonia post-stroke. This study aims to investigate the acute effect of WBV on leg muscle H-reflex, stiffness, and blood perfusion in people with chronic stroke.

Spastic hypertonia is common after stroke. Whole-body vibration (WBV) is known to have modulatory effects of muscle reflex activity and blood flow in other populations and thus have potential applications in management of spastic hypertonia post-stroke. However, the potential effects of WBV on leg muscle stiffness in stroke rehabilitation remains unknown. Scientific evidence is warranted to fill the knowledge gap.

Purpose This study aims to investigate the acute effect of WBV on leg muscle H-reflex, stiffness and blood perfusion in people with chronic stroke.

Methods Individuals with chronic stroke will be recruited from community self-help groups and existing patient database. Relevant information (e.g. demographic information, medical history) will be obtained from medical records and subject interviews. Each subject will have to fulfill the following inclusion criteria: (1) diagnosis of chronic stroke, (2) community-dwelling, (3) able to follow simple verbal instructions. Exclusion criteria are: (1) other diagnoses of neurological conditions, (2) significant musculoskeletal conditions (e.g. amputations), (3) metal implants in the lower extremity or spine, (4) recent fracture in the lower extremity, (5) diagnosis of osteoporosis, (6) vestibular disorders, (7) peripheral vascular disease, and (11) other serious illnesses or contraindications to exercise.

This is a single-blinded randomized within-patient cross-over study. Each participant was evaluated for the soleus H-reflex, stiffness and blood perfusion of the medial gastrocnemius (MG) using ultrasound on both sides before and after either a 5-minute WBV intervention (30 Hertz, 1.5mm, knee flexed 60 degrees) or a no-WBV condition (5 minutes). The measurements were performed at baseline and every 1-min post-intervention up to 5 minutes. The outcomes generated included the soleus H/M ratio, shear modulus and vascular index (VI) of the MG muscle.

Eligibility Criteria:
Inclusion Criteria:

1. Adult with a diagnosis of a hemispheric stroke \>6 months,
2. Medically stable,
3. Able to stand independently for at least 1 minute and
4. Mas score \>1 measured at the ankle plantar flexors.

Exclusion Criteria:

1. Brainstem or cerebellar stroke,
2. Other neurological condition,
3. Serious musculoskeletal or cardiovascular disease,
4. Severe contracture of the ankle that the cannot be put in the neutral position.
5. Metal implants or recent fractures in the lower extremities or spine,
6. Fresh skin wound in lower extremities, especially popliteal fossa
7. Other severe illnesses or contraindication for exercise.
Ultrasound- Guided Mid Point Transverse Process to Pleura Block

Radical nephrectomy is the surgical process for the resection of malignant tumors of the kidney necessitating a subcostal flank incision.Mild to severe pain is observed in the postoperative period Ineffective pain management leads to several complications. The mid point transverse process to pleura block (MTP) , this technique was used for pain relief after mastectomy, thoracic, abdominal, and spinal surgery and was found effective due to its simplicity and lower risks compared to epidural analgesia.

Ineffective pain management leads to several complications including immobilization, thromboembolism, persisting chronic pain, increased opioid consumption, and delayed hospital discharge.\[3\]

Multimodal analgesic (MMA) regimens using several drugs and techniques are considered to be necessary for postoperative pain relief. Regional anesthesia techniques, mainly epidural analgesia and more recently, paravertebral blocks became crucial parts of a MMA regimen after the introduction of ultrasound (US) in the regional anesthesia practice.

The mid point transverse process to pleura block (MTP) block was first described as a modified paravertebral block in 2017. The local anesthetic drugs are administered between the transverse process and the pleura. This results in a local anesthetic drugs spread to the dorsal and ventral rami in the paravertebral space through the fenestrations in the superior costotranverse ligament (SCTL) at the level of injection, and frequently to adjacent levels.

This technique was used for pain relief after mastectomy, thoracic, abdominal, and spinal surgery and was found effective due to its simplicity and lower risks compared to epidural analgesia.

Eligibility Criteria:
* Inclusion Criteria: - ASA II and III patients
* scheduled for partial or radical nephrectomy
* standard flank incision either subcostal ,intercostal or supracostal approach
* under general anesthesia.

Exclusion Criteria:

* Bleeding disorders,
* Mental or cognitive dysfunction,
* History of chronic analgesic or drug abuse,
* Allergy to local anesthetics
* Local infection at site of block
Predictive Factors of Outcome of Mechanical Thrombectomy After Acute Ischemic Stroke

Predictive factors of outcome of mechanical thrombectomy after acute ischemic stroke

Acute ischemic stroke is one of the most common causes of disability, dementia and death in developing world. In Egypt, the total lifetime prevalence of ischemic stroke was 7.2/1,000 in the population aged 20 years and more . Although the intravenous thrombolysis is a treatment option within ≤ 4.5 hours after stroke onset, the mechanical thrombectomy can be performed within a more extended time window. A positive results of 5 recent randomized clinical trials are driven mainly from patients treated by mechanical thrombectomy within 6 hours from onset and they demonstrated a clear benefit for mechanical thrombectomy in combination with intravenous thrombolysis. More recent two randomized clinical trials DAWN and DEFUSE 3 demonstrated an overall benefit in functional outcome at 90 days in patients treated with mechanical thrombectomy within 6 to 24 hours or 6 to 16 hours form onset respectively with special criteria. A major issue remains as to identifying patients which likely to benefit from mechanical thrombectomy to improve selection and subsequently clinical prognosis .

These factors include:-

1. Time of presentation.
2. Age.
3. Clinical presentation.
4. Risk factors include Hyperglycemia, peripheral vessel disease, atrial fibrillation, coronary heart disease, hyperlipidemia, smoking, and history of pervious stroke,
5. Socioeconomic status.
6. Collateral and stroke core. In this study the investigators will evaluate prognostic factors influencing angiographic and clinical outcomes at discharge and at three months after mechanical thrombectomy of acute ischemic stroke within 24 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years
2. Cerebral infarction in the anterior or posterior circulation (intracranial internal carotid artery, M1 or M2 middle cerebral artery, basilar or vertebral arteries) proven by Computed tomography angiography
3. With or without intravenous thrombolysis
4. Access to endovascular treatment within 24 hours from onset.
5. In selected patients with acute ischemic stroke within 6 to 24 hours of onset must meet DAWN or DEFUSE 3 eligibility criteria.

Exclusion Criteria:

1. Proven occlusion of the cervical carotid artery
2. Disability prior to the stroke (modified ranking scale \>3)
3. Opposition of the patient or their family
Effect of Mannitol on Optic Nerve Sheath Diameter in Patients Undergoing Robotic Prostatectomy

We aim to evaluate the change in optic nerve sheath diameters as a surrogate of intracranial pressure before and after mannitol administration in patients who undergo robot assisted laparoscopic radical prostatectomy with pneumoperitoneum and Trendelenburg position.

Mannitol has been frequently used for renal protection during surgery. Optic nerve sheath diameter is used to evaluate intracranial pressure noninvasively. Robot-assisted laparoscopic radical prostatectomy can induce an increase in optic nerve sheath diameter due to Trendelenburg position and carbon dioxide insufflation. We therefore aim to evaluate the change in optic nerve sheath diameters before and after mannitol administration in patients who undergo robot assisted laparoscopic radical prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

* prostate cancer patients undergoing robot assisted laparoscopic radical prostatectomy.
* 20 year old or above, 79 year old or below.
* agreed to participate this study.

Exclusion Criteria:

* history of cerebrovascular accident.
* history of congestive heart failure.
* history of pulmonary edema.
* history of anaphylaxis to mannitol.
* conversion to open prostatectomy.
* combined with other operation.
* inability to measure optic nerve sheath diameter.
A Clinical Trial to Explore Safety and Efficacy of Different Doses of Pegaptanib Sodium, Compared to Sham, in Patients With Wet AMD.

The purpose of this study is to compare the ability of different doses of pegaptanib sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or impriving vision in patients with wet AMD when compared to placebo injections.


Eligibility Criteria:
Inclusion Criteria:

Subjects of either gender, aged 50 years or greater. Subfoveal choroidal neovascularization (CNV) due to AMD. Best corrected visual acuity in the study eye between 20/40 and 20/320.

Exclusion Criteria:

Any prior subfoveal thermal laser therapy.
Clinical Study of Huperzine A in the Treatment of Patients With Hypertensive Cerebral Hemorrhage

1. To evaluate the effectiveness of Huperzine A injection in the treatment of brain injury in patients with hypertensive cerebral hemorrhage；
2. To evaluate the safety of Huperzine A injection in the treatment of brain injury in patients with hypertensive cerebral hemorrhage。

A randomized, controlled, single-center, exploratory clinical research method was used. In the treatment plan, the experimental group used basic treatment + Huperzine A, and the control group only used basic treatment, with a total of 20 cases. To evaluate the effectiveness and safety of Huperzine A injection in the treatment of brain injury in patients with hypertensive cerebral hemorrhage.

Eligibility Criteria:
Inclusion Criteria:

1. Aged from 18 to 75 years old(including 18 and 75 years old), males or females;
2. First onset, clinical diagnosis of hypertensive intracerebral hemorrhage, and CT confirmed that the amount of hemorrhage is between 15ml-50ml, the bleeding site is the basal ganglia, the bleeding has not penetrated into the lateral ventricle, and non-surgical patients；
3. Those with obvious neurological dysfunction after the onset, 5≤GCS≤15 or NIHSS≥6；
4. Admission within 72 hours after the onset of the disease, and no significant enlargement of the hematoma within 24 hours after admission (hematoma enlargement ≤ 5ml)；
5. The patient/family knows and signs the informed consent form voluntarily.

Exclusion Criteria:

1. Cerebral hemorrhage caused by cerebral aneurysm, brain tumor, brain trauma, cerebral parasitic disease, cerebrovascular malformation, abnormal blood vessel network at the base of the brain, cerebral arteritis, blood disease, metabolic disorder and other diseases confirmed by examination;
2. Patients with enlarged hematoma found within 24 hours after admission (the volume of enlarged hematoma\> 5ml);
3. Patients with simple transient ischemic attack, lacunar infarction, subarachnoid hemorrhage and ischemic cerebral infarction;
4. Patients who use anticoagulant drugs for a long time;
5. Patients with platelet count \<100,000, INR\>1.4 at admission and abnormal blood coagulation function;
6. The measured value of homocysteine at admission is higher than 15μmol/L;
7. Patients who need surgical treatment (including ventricular drainage);
8. Patients with severe primary diseases such as cardiovascular, liver (ALT or AST\>1.5 times the upper limit of normal), kidneys (BUN\>1.5 times the upper limit of normal and Cr\>upper limit of normal), endocrine system and hematopoietic system;
9. Those who are allergic to protein and test drugs;
10. People who are dependent on drugs or alcohol;
11. Intended pregnancy or women of childbearing age with positive pregnancy test and lactating women;
12. Participated in other clinical trials within the past 3 months;
13. Patients considered by the investigator to be inappropriate to participate in clinical trials.