cyrilzakka/clinical-trials huggingface dataset:
Effects of Electrical Nervous Stimulation Transcutaneous in Hypertensive Patients

Systemic arterial hypertension is a disease characterized by high blood pressure levels. It has a high prevalence, is a precursor of cardiovascular diseases, resulting in high costs to the health system and increased mortality. Transcutaneous electrical nerve stimulation (TENS) is a low-frequency pulsed electrical current widely used for analgesia. Recently, it has been proposed as a non-pharmacological strategy for blood pressure control. The aim of this study is to verify the effect of low-frequency TENS when applied in different anatomical sites on blood pressure, autonomic control and endothelial function in hypertensive patients.

Systemic arterial hypertension is a disease characterized by high blood pressure levels. It has a high prevalence, is a precursor of cardiovascular diseases, resulting in high costs to the health system and increased mortality. Transcutaneous electrical nerve stimulation (TENS) is a low-frequency pulsed electrical current widely used for analgesia. Recently, it has been proposed as a non-pharmacological strategy for blood pressure control. The aim of this study is to verify the effect of low-frequency TENS when applied in different anatomical sites on blood pressure, autonomic control and endothelial function in hypertensive patients. For this, patients will be randomized into 4 groups: group 1 (cervical stimulation), group 2 (plus cervical stimulation ), group 3 (renal stimulation), group 4 (control). Group 1 will receive TENS in the cervical paravertebral region; group 2 will receive stimulation in the cervical paravertebral region, ear lobe, wrist and ankle. Group 3 will have the anatomical region of the kidneys stimulated. Group 4 will not receive any intervention. All the treated patients will receive 30 minutes of stimulation per session, regardless of group allocation. Ten applications will be carried out over the course of a month.

Eligibility Criteria:
Inclusion Criteria:

- Diagnosis of systemic arterial hypertension: systolic blood pressure (SBP) ≥ 130 mmHg and diastolic blood pressure (DBP) ≥ 80 mmHg diagnosed by ambulatory blood pressure monitoring (ABPM).

Exclusion Criteria:

* Congestive heart failure
* Patients with a cardiac pacemaker
* Previous heart surgery
* Patients with serum creatinine \>2.5 mg/dL
* Change in drug therapy in the two months prior to starting the study
* Active smoking
CTRP3 and Progranulin in Patients With Coronary Artery Disease

Visceral obesity is the one of the major causes of cardiovascular morbidity and mortality in industrialized countries. Adipose tissue secretes various kinds of bioactive molecules termed adipokines which contribute to the development of obesity-related disorders including cardiovascular disease (CVD). Progranulin and CTRP3 are recently discovered novel adipokines. Therefore, the investigators tried to compare circulating CTRP-3 and progranulin levels in patients with CAD and investigated whether CTRP-3 or progranulin is significantly associated with CAD prevalence after adjustment for well-known CAD risk factors.

CTRP-3 (synonyms CORS-26, cartducin and cartonectin) is a potent anti-inflammatory adipokine that inhibits proinflammatory pathways in monocytes and adipocytes. Using a recently developed enzymelinked immunosorbent assay (ELISA), we reported that circulating CTRP-3 levels were elevated in patients with glucose metabolism dysregulation.

Progranulin was identified as a key adipokine mediating high fat diet-induced insulin resistance and obesity through interleukin-6 (IL-6) in adipose tissue. We previously reported that progranulin levels were significantly higher in individuals with type 2 diabetes and were associated with macrophage infiltration in omental adipose tissue. Moreover, the expression of progranulin reduces inflammation and its degradation into granulins peptides enhances inflammation in atherosclerotic plaque, which may contribute to the progression of atherosclerosis There has been no previous report on the implication of CTRP-3 or progranulin in humans with cardiovascular disease (CAD). In the present study, we compared circulating CTRP-3 and progranulin levels in patients with CAD and investigated whether CTRP-3 or progranulin is significantly associated with CAD prevalence after adjustment for well known CAD risk factors.

Eligibility Criteria:
Inclusion Criteria:

* acute myocardial infarction
* unstable angina
* stable angina pectoris

Exclusion Criteria:

For control group, we exclude the participants who had

* a history of CVD (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
* type 2 diabetes
* stage 2 hypertension (resting blood pressure, ≥160/100 mmHg)
* malignancy
* severe renal or hepatic disease
Clinical Trial Comparing Two Health Education Programs for Obese Patients (HEPO-TRIAL)

Clinical trial comparing two health education programs for obese patients in order to achieve a substantial and beneficial weight loss, using mediterranean diet. Patients will be allocated to two groups, one will receive education in diet and lifestyle, and the other one the same plus cooking lessons. The intervention period is for 6 months with monthly visits and phone and email contacts in between. An extension observation period of two years is also planned with 6 months contacts in our clinic, also with phone and email contact available.

Eligibility: obese patients attending our center. Exclusion criteria: previous dietary or anti-obesity drugs treatments, previous bariatric surgery, eating disorders, desire for short-term bariatric surgery, active neoplasia, end stage kidney or liver disease, food allergies or celiac disease.

Sample Size: a total of 260 patients (130 patients in each group) are needed for α=0.05 and 1-ß=0.8, to reach a difference of a 5% in weight loss between both groups, with a maximum of a 30% dropouts.

Intervention: structured health education program of Mediterranean diet and lifestyle changes with cooking lessons in monthly sessions, with the aid of phone and email contacts during an induction phase of 6 months, followed by an extension period of 18 months.

Control: same strategy without the cooking lessons. Primary outcome: weight loss in % Secondary outcomes: reversal in obesity associated comorbidities and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Obese patients attending our center

Exclusion Criteria:

* Previous dietary or pharmacologic treatment for obesity, previous bariatric surgery, desired bariatric surgery in the short-term, eating disorders, end-stage kidney or liver disease, active neoplasia, food allergies, celiac disease.
Presentation, Clinical Course and Patterns of Myocardial Damage Due to Viral Myocarditis

Presentation, Clinical Course and Patterns of Myocardial Damage due to Viral Myocarditis

1. Determine the pattern of myocarditis in hospitalized patients with acute HF within the last 3 months.
2. Determine the pattern of broad spectrum cardiotropic viruses in patients with acute HF within the last 3 months. These viruses like enteroviruses, adenoviruses and parvo B19 virus, HBV, HCV and Covid 19 virus due to its increased prevelance nowadays.

Eligibility Criteria:
Inclusion Criteria: All patients admitted with symptoms , signs and echocardiographic finding suggesting myocarditis within 3 months from start of the symptoms. as acute heart failure, arrhythmias, typical chest pain with ST segment deviation in ECG . dilated cardiomyopathy associated with normal Coronary Angiography, history of upper respiratory tract infection within the last 3 months.

Exclusion Criteria:

1. Patients with significant coronary artery disease.
2. Patient with family history suggesting familial DCMP
3. Critically ill patients.
4. Patients who refuse to do coronary angiography . .
5. Patients with severe valvular heart disease.
6. Pregnant women
7. Patients with raised renal chemistry.
8. Echocardiographic finding showing LVEDD more than 6.5cm
Evaluation of Negative Inspiratory Flow in Children With Acute Asthma

There are different inhalers used for the treatment of asthma and they work differently and require different technique for the optimal drug delivery to the lungs. One of the inhalers is the Dry Powder Inhaler (DPI). The minimal amount of Negative Inspiratory Flow (NIF) required to use this medication is 30ml/min. Studies have shown that children find it difficult to generate this NIF and studies have also shown that children generate lesser NIF during an Asthma exacerbation. The investigators will measure the NIF using an InCheck Dial on children with asthma during an exacerbation and when they are seen in clinic for a hospital follow up visit. This will be done on asthmatic children regardless of the inhaler that they use. The investigator hypothesize that children with asthma age 4-8 years cannot generate the required NIF during an Asthma exacerbation hence proving that a DPI cannot be prescribed to children at this age. This study will examine this hypothesis.

Inhaler devices are the major method for delivery of asthma medication, but their effectiveness can be compromised if the patient uses the inhaler device incorrectly. The magnitude of this problem has been well documented; in several studies less than half of the patients used their inhaler correctly. Inhaler devices are used to deliver a variety of inhaled medications, including beta-agonists, anticholinergic, and glucocorticoids. Two main types of inhaler devices are available, the pressurized metered dose inhaler (pMDI) and the dry powder inhaler (DPI).

A dry powder inhaler (DPI) is a breath-actuated device containing micronized drug particles with a mass median aerodynamic diameter (MMAD) of less than 5 µm that are usually aggregated with carrier particles (such as lactose or glucose) of greater diameter. Drug is delivered to the airways by the inhalation of air over a punctured drug-containing capsule or blister.

In this study investigators will evaluate the use of DPI use in children during an acute asthma exacerbation. The investigators hypothesize the use of DPI in children ages 4-8 during an asthma exacerbation has limited benefit, as children are unable to generate the needed NIF. The investigators will study children who were hospitalized for an acute asthma exacerbation. Additionally, the investigators will evaluate the participant as an outpatient in the pulmonary clinic / office when the participant is without an asthma exacerbation.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized with asthma
* Age ≥ 4 years and \< 8 years

Exclusion Criteria:

* Acute Lung Disease
* Chronic lung disease
* Developmental Delay
Air Pollution and Cardiovascular Disease

To determine the effects of ambient airpollution exposures on cardiovascular responses among healthy adults without cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* without CV disease or risk factors (e.g., hypertension, diabetes, or treated hyperlipidemia). Subjects are non-smokers in non-smoking household.

Exclusion Criteria:

* Screening visit BP\>140/90 mm Hg, fasting glucose \>126 mg/dL, or positive urine pregnancy test (females). Subjects cannot be taking any medications or over-the-counter drugs that affect CV function.
Protect II, A Prospective, Multicenter Randomized Controlled Trial

The IMPELLA® 2.5 System will be superior to Intra Aortic Balloon Pump in preventing the composite rate of major adverse events during and after the PCI procedure.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Subject is indicated for a NON emergent percutaneous treatment of at least on de novo or restenotic lesion in a native coronary vessel or bypass graft.
* Patient presents with:

  * A compromised Ejection Fraction
  * Intervention on the last patent coronary conduit
  * Intervention on an unprotected left main artery or
  * Patient presenting with triple vessel disease.

Exclusion Criteria:

* ST elevation M.I.
* Pre procedure cardiac arrest within 24 hours.
* Subject in cardiogenic shock
Effects of the Myofascial Induction Technique Versus a Control Laser

The objective is to determine the effectiveness of myofascial Induction effects on plantar pressures variables. Forty healthy subjects will be recruited for a simple blind clinical trial. All subjects will be randomly distributed in two different groups: control group (sham Laser) and experimental group (myofascial Induction). Outcome measurements will be foot plantar pressure area (footprint) by a validated platform. Two trials will be recorded before and after intervention in standing position.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals without pain.

Exclusion Criteria:

* Previous lower extremities surgery
* History of lower extremities injury with residual symptoms within the last year
* Evidence of a leg-length discrepancy of more than 1 cm
* Evidence of balance deficits
Immunotoxin in Peritoneal Carcinomatosis- ImmunoPeCa Trial

The purpose of this study is through a phase I/II clinical trial to assess the safety and toxicity of intraperitoneally administered MOC31PE immunotoxin, given on the 1.postoperative day after cytoreductive surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for peritoneal metastases from colorectal cancer (CRC).

MOC31PE is an immunotoxin that has previously been evaluated in a phase I clinical study involving patients with advanced EpCAM positive carcinoma to assess the safety and tolerability profile and the pharmacokinetic behavior of the compound. In this study, the compound was administered intravenously and was well tolerated. MOC31PE will now be evaluated on the same parameters in a new phase I/II clinical trial, where the drug will be administered intraperitoneally to patients with peritoneal metastases from EpCAM positive colorectal carcinomas.

Eligibility Criteria:
Inclusion criteria:

* Histologically verified EpCAM positive colorectal cancer
* Ambulatory with Eastern Cooperative Oncology Group (ECOG) performance status 0-1 at the time of surgery
* At least 18 years of age
* Suspected isolated peritoneal carcinomatosis upon radiologic work-up
* Complete cytoreduction at surgery and mitomycin C given as standard HIPEC procedure
* Peritoneal Cancer Index (PCI) ≤ 20
* Laboratory values at inclusion:

  * Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L
  * Platelets \> 100 x 10\^9/L
  * Hb \> 9g/dL
  * Creatinine ≤ 2x upper limit of normal
  * Bilirubin \< 2.0x the upper limit of normal
  * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2. 5x the upper limit of normal
  * Albumin levels \> 30 g/L
  * International normalised ratio (INR) \<1.3
* Signed informed consent and expected cooperation with respect to treatment and follow-up must be obtained and documented according to International Conference of Harmonisation- Good clinical Practice (ICH GCP), and national/local regulations.

Exclusion criteria:

* Other synchronous metastatic lesions. Patients may be included if they have had curative resection of metastatic CRC disease more than 2 years prior to inclusion and have no relapse at this location is detected.
* History of prior other malignant disease the last 3 years, except for adequately treated carcinoma of the cervix or basal or squamous cell skin cancer.
* History of central nervous system (CNS)- or bone metastases
* Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia
* History of any liver disease including Hepatitis B or C infection
* Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment
* BMI \> 35
* Pregnant or breast-feeding patients
* Alcohol or drug abuse
* Use of drugs that can influence hepatic function (e.g. phenytoin or phenobarbital)
* Use of anticoagulants
* Any reason why, in the opinion of the investigator, the patient should not participate in the study protocol
A Study of CS1001 in Combination With Donafenib in Subjects With Advanced Solid Tumors

This study will evaluate the safety, tolerability, pharmacokinetics and treatment effect of CS1001 in combination with Donafenib in patients with advanced solid tumors.

This trail uses an open, multi-center study design, Contains two parts: a dose escalation part and a dose expansion part.

Eligibility Criteria:
Inclusion Criteria:

* Fully understand this study and voluntarily sign ICF;
* 18 to 75 years old (including 18 and 75 years old), male or female;
* Subjects with advanced solid tumors, including:

Phase I study:

subjects with advanced solid tumors confirmed by histology or cytology that are not suitable for surgical resection, or have failed or tolerated standard treatment, or have no standard treatment. Including but not limited to Cholangiocarcinoma , head and neck squamous cell carcinoma (HNSCC) and endometrial cancer.

Exclusion Criteria:

* Any history of active autoimmune diseases or autoimmune diseases; patients with vitiligo or asthma that has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included;
* Participants with any condition that impairs their ability to take oral medication, such as lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
* Patients with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage and need to retain a catheter;
* Human immunodeficiency virus (HIV) antibody positive;
* Patients who are simultaneously infected with hepatitis B virus and hepatitis C virus;
* Lactating women. If they are willing to stop breastfeeding, they can also be included in this study.
Appropriateness of Aspirin Use in Medical Outpatients

This study aims to describe the demographic characteristics and current status of the aspirin use for primary and secondary prevention of cardiovascular diseases in a large, multicenter nationwide study

Although the benefit of aspirin use for secondary prevention is well established, its role in the primary prevention of cardiovascular diseases remains controversial. Differences in primary prevention guidelines may lead to underuse of aspirin in high-risk patients and overuse in low-risk patients. This study aims to describe the demographic characteristics and current status of the aspirin use for primary and secondary prevention of cardiovascular diseases in a large, multicenter nationwide study. The ASSOS trial (Appropriateness of Aspirin Use in Medical Outpatients: A Multicenter, Observational Study) will be an observational, multicenter, and non-interventional study conducted in Turkey. Approximately 5000 patients will be enrolled in this non-interventional study. All the data will be collected at one point in time and current clinical practice will be evaluated.

The investigators will enroll all consecutive patients admitted to the outpatient cardiology clinics from January 30, 2018, through May 30, 2018, who were at least 18 years of age, provided written informed consent, and currently treated with aspirin (80-325 mg)within the last 30 days. Hospital-based cardiologists in public units will be invited to participate in the study. Patients will be stratified into 2 categories based on the presence or absence of atherosclerotic cardiovascular disease; secondary prevention group and primary prevention group, respectively. Appropriateness of aspirin use in primary prevention group will be evaluated according to the US Preventive Services Task Force (USPSTF) and European Society of Cardiology (ESC) guidelines. Physicians will complete a standardized survey form to collect information on patient clinical characteristics, cardiovascular risk factors, medical history, clinical examination, laboratory test results, and medications. Patients' risk factors for colorectal cancer and gastrointestinal bleeding will also be questioned.

ASSOS registry will be the largest and most comprehensive study in Turkey evaluating aspirin use. The results of this study will provide valuable information regarding the potential misuse of aspirin in a real-world setting.

Eligibility Criteria:
Inclusion Criteria:

* Patients using aspirin 18 years and older

Exclusion Criteria:

* Patients under 18 years of age
* Patients who do not want to participate in our study
* Patients who do not use aspirin
An Explorative Trial Evaluating the Effect of LEO 32731 Cream in Adults With Mild to Moderate Atopic Dermatitis (AD)

The aim of this trial is to assess the efficacy of LEO 32731 cream 20 mg/g compared with LEO 32731 cream vehicle in adults with mild to moderate AD after 3 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Following verbal and written information about the trial, subjects must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures being carried out
* Subject with Atopic Dermatitis (AD) as defined by Hanifin and Rajka criteria and with mild to moderate disease severity (IGA 2 or 3) as assessed by a dermatologically trained investigator (and confirmed by a board certified dermatologist before or at visit 1)
* Two symmetrically located and comparable Entire Treatment Areas (ETAs) of 20 - 50 cm2 each, i.e. on the same body region (left and right part) and of the same size (complete AD lesion or part of an AD lesion); Total Sign Score (TSS) of at least 5 on both ETAs; difference in TSS not greater than 2 between the two ETAs; sign score for erythema ≥ 2 on both ETAs; difference in Investigator´s Treatment Area assessment of disease severity not greater than 1 between the 2 ETAs

Exclusion Criteria:

* Any condition in the treatment areas that in the opinion of the investigator could interfere with clinical assessments, e.g. acne, infection, rash (other than Atopic Dermatitis), sunburn, hyper- or hypopigmentation, scars
Prevention of Postpartum Haemorrhage With Sublingual Misoprostol or Oxytocin

Sublingual misoprostol produces rapid peak concentration and is more effective than oral misoprostol for prevention of excessive postpartum bleeding. The study hypothesis was to test whether women receiving sublingual misoprostol for prevention of postpartum hemorrhage have 30 ml less average blood loss than women receiving oxytocin, the standard of care for prevention of postpartum hemorrhage. We conducted a Double blind randomized controlled trial of .652 consenting, eligible pregnant women admitted to the labor room of the teaching hospital at J N Medical College, Belgaum, India. Women participating in the study were assigned by computer generated randomization to receive the study medications and placebos within one minute after clamping and cutting the umbilical cord. We also looked at the drugs effects on postpartum blood loss at or above ≥500 ml (considered hemorrhage), and the percent of women experiencing more than a 10% decline in haemoglobin, and reported drug side effects.


Eligibility Criteria:
Inclusion Criteria:

* Women with a gestational age \>28weeks
* singleton pregnancy with cephalic presentation anticipating a normal spontaneous vaginal delivery (including episiotomy)
* a haemoglobin ≥ 8g/dl upon presentation who were admitted to labour room in the KLE teaching hospital attached to J N Medical College, Belgaum

Exclusion Criteria:

* Women with pregnancy induced hypertension
* antepartum haemorrhage
* previous caesarean section or presence of uterine scar
* diagnosed chorioamnionitis
* oxytocin induction or augmentation of labour
* intrauterine death
* diagnosed medical disorders (such as diabetes, cardiac, renal and hepatic diseases, etc.) or those in active labour (defined as \>4 cm dilatation)