cyrilzakka/clinical-trials huggingface dataset:
The Impact of Inorganic Nitrate-rich Beetroot Juice on Microvascular Blood Flow and Cognitive Function

Cardiovascular disease (CVD) is one of the leading causes of mortality worldwide. Inorganic nitrate found in beetroot and green leafy vegetables has been demonstrated to reduce cardiovascular disease risk factors including reducing blood pressure and the stiffness of blood vessels by increasing levels of a compound called nitric oxide. Much of the research to date has focused on the large blood vessels, and little is known about the impact of inorganic nitrate on smaller blood vessels which could be related to cognitive function.

The majority of beneficial effects with inorganic nitrate have been observed within young healthy populations. However, it is known that after the menopause women are at an increased risk of cardiovascular disease and have reduced levels of nitric oxide in their body; this could also contribute to the cognitive decline also observed post-menopause. This trial will investigate the impact of inorganic nitrate from beetroot juice on the blood flow in small blood vessels and on cognitive function in postmenopausal women. The hypothesis of the study is that the nitrate in beetroot juice will increase circulating nitric oxide that will then increase blood flow in small blood vessels and improve cognitive function.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy post-menopausal women (age over 45)
* Able to understand information sheet and willing to comply with the study protocol and able to give informed consent
* Not having menstrual period for 12 months

Exclusion Criteria:

* Blood pressure \<90/60 or \> 140/90 mmHg
* Medical history of myocardial infarction, angina, thrombosis, stroke, cancer, high cholesterol, liver, renal, respiratory or bowel diseases or diabetes or other endocrine disorder
* BMI\>30
* Any tobacco and/or nicotine users (or quit within the last 6 months)
* Current use of antihypertensive medication
* Alcohol intake \> 14 units/week
* Vigorous exercise \> 3 times/ week
* Antihypertensive medication users
* People who have had hysterectomy
* Currently taking hormone replacement therapy or selective oestrogen receptor modulator
Vasculaire Compression System Increases Flow Velocity in the Femoral Vein

The objective of this clinical study was to demonstrate the performance of the Vasculaire Compression System to increase femoral venous peak velocity (PFV) in healthy subjects. This study was a single-arm, open label, prospective, single-center clinical study.

Venous thromboembolism, e.g. deep vein thrombosis (DVT) and pulmonary embolism, occurs in approximately one in 1,000 persons in the United States annually and results in more than 250,000 hospital admissions annually in the United States. Intermittent pneumatic compression (IPC), which prevents stasis in the lower limbs, has been shown to be a safe and effective method of prophylaxis of DVT in studies comparing the incidence of DVT and pulmonary embolism with and without IPC. IPC devices decrease venous stasis by augmenting the venous blood flow in the lower extremities. Studies have suggested that an important indicator of the effectiveness of an IPC device in preventing DVT is the peak femoral venous velocity augmentation during the compression phase as compared with the decompression phase of the device.

IPC devices produced in the early 1980s and 1990s were cumbersome, noisy and required external power sources, making them suitable only for non-ambulatory patients. Furthermore, these devices have been associated with poor compliance in trauma patients in a hospital setting, and the poor compliance was associated with a higher rate of DVT.

The aim of this study is to test the hemodynamic performance of a new portable IPC device, the Venous Health Systems' Vasculaire Compression System. This new device is designed to provide patient comfort and convenience of use while providing similar improvement in venous blood flow when compared with existing IPC devices.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between 18 years old and 65 years old;
* Capable of and willing to lay supine for approximately one hour;
* Subjects must provide written informed consent

Exclusion Criteria:

* History of Deep Vein Thrombosis (DVT) or suspected DVT;
* History of vascular disease, e.g. coronary or peripheral artery disease;
* History of stroke;
* History of pulmonary edema;
* History of congestive heart failure;
* Diabetes mellitus;
* Past or present smoker;
* Surgery or trauma to the right leg within the last six months;
* Open ulcers or wounds on the right leg;
* Pregnant or breastfeeding.
Clinical Trial to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Volunteers.

This Clinical Trial is an open, randomized, fasted, single-dose, oral administration 2-sequence, 2-period crossover study to assess bioequivalence of lazertinib between two formulations in healthy adult volunteers. The subjects administer 240mg of lazertinib of different formulations on the fasted status on each period and have a wash-out period for 14-21 days between the first and second period.

This clinical trial will be conducted in healthy male volunteers at Seoul National University Hospital (SNUH) Clinical Trial Center.

It is expected to take approximately 32 days from the first dosing of Investigational Product until the final follow-up visit. Subjects will be hospitalized twice for 4 nights and 5 days with 7-14 days of wash-out period, and one visit will be needed for safety evaluation between 14-17 days from the last dosing of the Investigational Product.

Eligibility Criteria:
Inclusion Criteria:

* Male, over 19 years of age
* Male participants must agree to use an adequate contraception method from the first to the third month after the last dose.
* Participants must have a body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive(BMI = weight/height2), and body weight not less than 50 kg.
* Subjects without congenital or chronic diseases within the last 3 years and without pathologic symptoms as determined by medical diagnosis.
* Participants must be healthy on the basis of clinical laboratory tests performed at screening.
* Informed of the investigational nature of this study and voluntarily agree to participate in this study.

Exclusion Criteria:

* Clinically significant medical or psychiatric illness.
* Hypotension (SBP ≤ 90 mmHg or DBP ≤ 50 mmHg) or hypertension (SBP ≥ 150 mmHg or DBP ≥ 100 mmHg).
* A marked baseline prolongation of QTc.
* Within 14 days prior to the first administration of investigational product, use of prescription drugs or herbal medication, or within 7 days use of any over-the-counter medications
* Participants who are planning COVID-19 vaccine within 14 days before the first intake of study drug and to the end of the trials.
Postoperative Analgesia After Minithoracotomy

Patients scheduled for minimally invasive mitral valve replacement. Each patient will be treated with intravenous (i.v.) oxycodone - patient-controlled analgesia (PCA). Half of the patients will be randomly allocated to Erector Spinae Plane (ESP) blockade group.

Only patients who are qualified for an elective procedure of mitral valve replacement may participate in the study. Each patient will be anesthetized generally. The same drugs will be used in each stage of anesthesia. The induction: etomidate, remifentanil, rocuronium, scolina as required. The maintenance: sevoflurane, remifentanil, rocuronium. The emergence: oxygen, sugammadex or neostigmine a required.

Patients will be randomly allocated into one of two groups: PCA or ESP. Among the patients from ESP group will have ESP blockade before the induction of general anesthesia. ESP blockade will be performed under ultrasound control. A single-shot technique will be used with 0.375 % solution of ropivacaine: 0.2 mL per patients' KG. The maximum dose is 40 mL.

Each patient, before the end of surgery, will be administered i.v. 0.1 mg of oxycodone. PCA with oxycodone (1mg/mL) will be utilized during the postoperative period: 5-minute interval. This is standard protocol in our department.

Only patients who are successfully awakened after the procedure may participate in the study.

The pain intensity will be assessed with visual-analogue scale (VAS) at 2, 4, 8, 12 and 24 hour after the end of anesthesia.

The total consumption of oxycodone will be also monitored.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled mitral valve replacement surgery
* obtained consent

Exclusion Criteria:

* allergy to oxycodone and local anesthetics
* depression, antidepressant drugs treatment
* epilepsy
* usage of painkiller before surgery
* addiction to alcohol or recreational drugs
* postoperative ventilation or ICU admission
Cardiovascular Fitness of Patients With Multiple Sclerosis, Effect of Exercise on Fatigue and Depression

This study is focused on patients with multiple sclerosis (MS), their cardiovascular fitness, and the effect of combined controlled training on the perception of fatigue, the development of depression, and quality of life in the first year after diagnosis.

The main goal is to find out if fatigue, depression, and quality of life depend on the type of training as well as controlled management of newly diagnosed patients. Fatigue is one of the frequent disabling symptoms and the most difficult to influence pharmacologically. It could lead to inactivity and the progression of deconditioning. We know from systematic reviews that aerobic activity leads to improvement in fatigue, however, there are also opinions about exercise intolerance due to disruption of cardiac autonomy control. The investigators will try to determine whether early rehabilitation intervention leads to support and motivation of patients with an incurable chronic neurodegenerative disease to improve the patient condition and contentment. The researchers will focus on effective training by comparing the study group with a control group of patients undergoing conventional rehabilitation versus a protocol-defined controlled combined (aerobic-resistant) exercise program - based on the results of spiroergometry. Both groups will be treated at ambulatory sections by protocol-defined rehabilitation for a 1-hour duration, twice a week for one month, and once a week for the next month (12 therapies in total). The control group will be educated in exercises according to kinesiological analysis to do regularly at home. Finally, the researchers will see if early intervention leads to a change in the active approach of probands.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 - 45 years
* Newly diagnosed patients with multiple sclerosis
* Relapsing-remitting MS (RRMS) or clinically isolated syndrome (CIS)
* EDSS 0-6
* Signed informed consent

Exclusion Criteria:

* Progressive forms of MS (PRMS or SPMS), Malignant MS
* Non-cooperation, disagreement with the study
* Contraindication to spiroergometry
Repetitive Transcranial Magnetic Stimulation in Treatment and Prophylaxis of Chronic Migraine in Patients With no Prophylactic Treatment for the Last 3 Months

Compared with the patients with episodic migraine those with chronic migraine have worst quality of life and more severe headache related disability we investigate Repetitive transcranial magnetic stimulation in treatment and prophylaxis of chronic migraine


Eligibility Criteria:
Inclusion criteria:

* A study sample of patients with chronic migraine according to international classification of headache disorders-3 (ICHD-3).
* Patients are regular on follow up visits.

Exclusion criteria:

* Patients with depression by Hamiliton scale of depression by using its Arabic version Translated by Dr Lotfy Fateem
* patients on prophylactic medications for chronic migraine.
* pregnancy.
* cochlear implants, cardiac pacemaker, and metal body implanted in head-and-neck region.
* Patients refused to give informed consent.
* History of seizures.
ZN-c3 in Adult Participants With Metastatic Colorectal Cancer

The purpose of this study is to evaluate the safety, tolerability, and potential clinical benefits of ZN-c3 administered in combination with encorafenib and cetuximab in adult participants with metastatic BRAF V600E mutant colorectal cancer previously treated with one or two treatment regimens.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic Stage IV colorectal adenocarcinoma.
* Documented evidence of a BRAF V600E mutation in tumor tissue or blood
* Presence of measurable disease per RECIST version 1.1 guidelines.
* Disease progression after 1 or 2 previous systemic regimens for metastatic disease
* Adequate bone marrow function
* Adequate hepatic and renal function

Exclusion Criteria:

* Documented clinical disease progression or radiographic disease progression during the screening period
* Leptomeningeal disease.
* Symptomatic brain metastasis.
* Presence of acute or chronic pancreatitis.
* Unable to swallow, retain, and absorb oral medications.
* Clinically significant cardiovascular diseases
* Evidence of active noninfectious pneumonitis.
* Evidence of active and uncontrolled bacterial or viral infection, within 2 weeks prior to start of any of the study interventions
* Participants with known positivity for HIV
* Active hepatitis B or hepatitis C infection
* Concurrent or previous other malignancy within 2 years of study entry
* Has had an allogeneic tissue/solid organ transplant
* Pregnant or females of childbearing potential who have a positive β-hCG laboratory test result within 14 days prior to enrollment or is breastfeeding
Low-dose Combination of Three Antihypertensive Drugs

The aim of the study is to compare the efficacy and safety of low-dose combination of three antihypertensive drugs versus fixed high-dose combination of two antihypertensive drugs in arterial hypertension

The aim of the study is to compare the efficacy and safety of commercially available low-dose combination of three antihypertensive drugs versus commercially available fixed high-dose combination of two antihypertensive drugs in arterial hypertension

Eligibility Criteria:
Inclusion Criteria:

Patients with arterial hypertension resistant to monotherapy

Exclusion Criteria:

None
Indocyanine Green Versus Blue Dye for Detection of Sentinel Lymph Node In Endometrial Cancer

To determine the difference in the proportion of hemipelves with successful detection of Sentinel Lymph Node according to the dye used (indocyanine green with near-infrared imaging vs blue dye) in women with endometrial cancer.

In the past few years, Sentinel Lymph Node (SLN) procedure has emerged as an interesting solution to the debate on lymphadenectomy in endometrial cancer. Using blue-dye is inexpensive but results in an unsatisfactory detection rate of SLN. IndoCyanine Green (ICG) with near-infrared imaging is a novel technology for SLN mapping and initial reports on the use of ICG have shown high detection rate. In the present study, we aim to determine precisely the increase in detection rate of SLN associated with the use of ICG instead of blue dye. This randomized controlled trial will include patients with preoperative stage I endometrial carcinoma. All included women will undergo SLN mapping with blue dye in one hemipelvis and ICG in the other hemipelvis. Randomization will concern the side of the hemipelvis in which blue dye vs ICG mapping is used, so that the patient's contralateral hemipelvis will serve as a control to her ipsilateral hemipelvis. The primary endpoint is the difference in the proportion of hemipelves with successful detection of SLN according to the dye used. The unique precise information gained from the present study will contribute to determine whether the benefit of the use of ICG over blue dye is sufficient to justify the expense of its use.

Eligibility Criteria:
Inclusion Criteria:

* all patients with endometrial carcinoma proven by endometrial biopsy or curettage AND
* preoperative FIGO (International Federation of Gynecology and Obstetrics) stage I AND
* intended for staging via laparoscopic or robotic surgery AND
* Patients must be older than 18 year-old, able to read French or English.

Exclusion Criteria:

* preoperative FIGO stages II to IV
* previous pelvic or paraaortic lymphadenectomy or radiotherapy
* surgery that could change the uterine lymphatic drainage (myomectomy)
* iodine allergy
* pregnancy.
Laparoscopic-guided TAP Block vs Epidural Analgesia

The LAPTAP trial will provide evidence on preferred post-operative analgesia method in elective laparoscopic colon surgery.

In most previous studies TAP-block has been inserted by anesthesiologist under ultrasound guidance. TAP blockade can alternatively be performed by a surgeon with laparoscopic visual guidance during trocar placement by aiming injection into fascial plane between the internal oblique and transversus abdominis in the midaxillary line and repeated on the contralateral side. There is lack in studies comparing laparoscopic guided TAP-blockade versus epidural pain analgesia in elective laparoscopic colon surgery exist.

Eligibility Criteria:
IInclusion criteria

* Patients who undergo elective laparoscopic colorectal surgery for colorectal neoplasia, diverticulitis, and other diseases of the colon and rectosigmal area
* Patients able to provide informed written consent
* Patients capable of completing questionnaires at the time of consent

Exclusion criteria

* Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivacaine, fentanyl and/or oxycodone
* Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, elevated international normal ratio (INR), anticoagulation, patient refusal, etc.) or TAP block (patient refusal)
* Urgent or emergent surgery precluding epidural catheter placement or TAP block
* Systemic Infection contraindicating epidural catheter placement or TAP block
* Rectal surgery
* Pregnant or suspected pregnancy
* Age \< 18 years
* Planned open surgery
* Planned bowel stoma (protective diversion and/or permanent stoma)
* Unwillingness to participate in follow-up assessments
* Patients with severe chronic pain
* Known sensibility for opioid side effects
* i.v.-PCA is contraindicated (for example drug abuse)
* No informed consent
Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel/Carboplatin vs. Paclitaxel /Carboplatin in Stage Ⅱ B and IIIA Squamous Cell Carcinoma of the Lung

Albumin-bound paclitaxel plus carboplatin regimen in advanced NSCLC especially in lung squamous cell carcinoma has a better tumor response rate and safety, therefore.The main purpose of this study is to observe the safety and efficacy of albumin-bound paclitaxel / carboplatin in the treatment of lung squamous cell carcinoma of stage IIB and IIIA.

Albumin-bound paclitaxel plus carboplatin regimen in advanced NSCLC especially in lung squamous cell carcinoma has a better tumor response rate and safety, therefore, this program is applied to neoadjuvant therapy, may obtain better tumor pathological remission rate, improve the operation resection rate, thus improve the prognosis.The main purpose of this study is to observe the safety and efficacy of albumin-bound paclitaxel / carboplatin in the treatment of lung squamous cell carcinoma of stage IIB and IIIA.

Eligibility Criteria:
Inclusion Criteria:

1.Histological or cytological diagnosis of lung squamous cell carcinoma of stage IIB and IIIA.

2.18 years or older 3.ECOG Performance Status no more than 2; 4.Appraisable disease, the presence of at least three lesions if longest diameter \<10 mm by brain MRI; 5.Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5 x 10E9/L, platelets 100 x 10E9/L; 6.Total bilirubin 1.5 x upper limit of normal (ULN); 7.ALT and AST \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases; 8.Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula).

Exclusion Criteria:

1. Any systemic anticancer treatment for NSCLC
2. Local radiotherapy for NSCLC.
3. In this study within five years prior to the start of treatment with other than NSCLC patients with other cancers.
4. Any instability in systemic disease, including: active infection, absence of control hypertension, unstable angina, begins in the last 3 months of angina pectoris, congestive heart failure
5. HIV infection;
6. Allergic to paclitaxel or Platinum;
7. mixed with adenocarcinoma, small cell lung cancer;
8. Pregnant or lactating women;
9. Other researchers believe that does not fit into the group
Non-US Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease

This 12-month study had two phases: a 90-day double-blind, randomized, placebo-controlled phase and a nine-month open-label extension phase. Before treatment, eligible subjects were stratified by the primary joint type (30 metacarpophalangeal \[MP\] joints and 30 proximal interphalangeal \[PIP\] joints) and by severity of the primary joint contracture (ie, up to 50° or \>50° for MP joints and up to 40° or \>40° for PIP joints) and then randomized in a 2:1 ratio to either AA4500 0.58 mg or placebo. Upon completion of the double-blind phase (ie, 90-day evaluation after the first injection), all subjects were eligible to enter the open-label extension phase of the study in which they were followed for an additional nine months. Subjects who required further treatment because they either did not achieve reduction in contracture to 5° or less, the cord affecting the primary joint received placebo, another cord received less than three injections of AA4500, or they had untreated cords that were affecting other joints had the option to receive up to five additional injections of AA4500 0.58 mg in the open-label extension phase, with individual cords receiving up to three injections of AA4500.

This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 \[NCT00528606\] and AUX-CC-859 \[NCT00533273\]) and 7 non-pivotal studies were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of advanced Dupuytren's disease, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100°, for MP (80° for PIP) joints, caused by a palpable cord.
* Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
* Were naive to AA4500 treatment
* Were judged to be in good health, based upon the results of a medical history, physical examination, and safety laboratory profile.

Exclusion Criteria:

* Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
* Had received a treatment for advanced Dupuytren's disease, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study drug.
* Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.