cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of S-Amlodipine Gentisate Compared to Amlodipine Besylate to Treat Mild-to-Moderate Hypertension

The goal of this study is to compare the antihypertensive effect and tolerability of S-amlodipine gentisate with those of amlodipine besylate in patients with mild to moderate hypertension.


Eligibility Criteria:
Inclusion Criteria:

* patients are required to have a mean cuff sitting diastolic blood pressure of ≥90 and ≤109 mmHg after successful completion of the 2-week placebo run-in period

Exclusion Criteria:

* any serious disorder that could limit the ability of the patient to participate in the study
* significant cardiovascular disease (angina, myocardial infarction, cerebrovascular disease, or significant arrhythmia in the preceding 6 months)
* uncontrolled diabetes mellitus (serum glucose level ≥140 mg/dl)
* insulin dependent diabetes mellitus (type I)
* secondary hypertension
Perfusion CT as a Predictor for Response to Antiangiogenic Therapy in Patients With Metastasized Renal Cell Carcinoma

The purpose of this study is the evaluation of dynamic contrast-enhanced CT (Perfusion-CT) for therapeutic response predicition in patients with metastasized renal carcinoma (mRCC) undergoing antiangiogenetic therapy (AAT) with multikinase inhibitors.

In this study patients with mRCC under AAT will be examined with 3 serial Perfusion - CT scans - partially intergrated in their regular staging CT scheme - at baseline (before AAT start), 1 week after AAT as well as 8 weeks after AAT initialization. Thereby selected intrabdomial or intrathoracic metastases will be monitored longitudinally with perfusion CT. Pretreament and post-treament perfusion characteristics of the assessed metastatic lesions will be quantified and correlated with patient outcome.


Eligibility Criteria:
Inclusion Criteria:

* patients with metastasized renal cell carcinoma treated at the Department of Urology (University of Munich - Grosshadern Campus)

  1. with either - Sunitinib (Sutent®), Pazopanib (Votrient ®) bzw. Sorafenib (Nexavar®) as first-line therapy
  2. with Sunitinib (Sutent®), Pazopanib (Votrient ®) bzw. Sorafenib (Nexavar®) as second-line therapy after failed first-line therapy, who are off therapy for at least 2 weeks
* no contraindications against contrast-enhanced CT
* obtained informed consent to participate in the study

Exclusion Criteria:

Patients who have:

* not given informed consent
* known iodine allergy
* high grade renal insuffiency (eGFR \< 30ml/min) not on dialysis
* overt hyperthyreoidism
* singular metastases \<1cm in diameter
* an increase of their baseline creatine levels of \>20% between CT examinations
Effect of Increased Fruit and Vegetable Intake on Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease (COPD) is the UK's fastest growing fatal disease and is estimated to cost the health service close to £1 billion every year. Around 80,000 people in Northern Ireland suffer from COPD. COPD is clinically defined as a slowly progressive condition characterised by airflow limitation, which is largely irreversible. Chronic inflammation and oxidative stress are key components of the underlying pathological process resulting in airflow limitation. Dietary factors and nutrients that have antioxidant or anti-inflammatory properties are therefore of interest with respect to the aetiology of COPD. The antioxidant vitamins C, E and beta-carotene are all present in the lung milieu. Such antioxidants represent the lung's first line of defence against oxygen free radicals. Observational studies indicate that a low dietary intake of antioxidant nutrients, or foods rich in antioxidants (e.g. fruit and vegetables), is associated with decreased lung function and increased risk of COPD. To date, there have been no food-based dietary interventions investigating the effect of increased fruit and vegetable intake on COPD. The investigators propose to recruit people with mild to moderate COPD and low fruit and vegetable intakes (\<=2 portions daily) and randomise them to one of two study arms for 12 weeks - either to increase fruit and vegetable consumption to at least 5 portions a day, or to follow their normal diet. Airway and systemic oxidative stress and inflammation will be assessed at baseline and post-intervention in order to determine if fruit and vegetables have the potential to alleviate the oxidative stress and airway inflammation associated with COPD.


Eligibility Criteria:
Inclusion Criteria:

* moderate to severe COPD (according to GOLD classification)
* oxygen saturation \>= 92 KPa
* symptomatically stable
* habitually low fruit and vegetable intakes (\<=2 portions daily)
* exercise limited by shortness of breath (rather than e.g. angina, arthritis)

Exclusion Criteria:

* diabetes
* taking antioxidant supplements or drugs
* oxygen saturation \<8KPa
Evaluating the Efficacy and Safety of Treatment With LinearFirm(ULTRAcel Q+) in Temporary Eyebrow Lifting

Prospective, single center, single arm, open label study to evaluate the efficacy and safety of treatment with LinearFirm(ULTRAcel Q+) in temporary eyebrow lifting

The goal of this open label study is to evaluate the efficacy and safety of treatment with HIFU system (LinearFirm(ULTRAcel Q+)) in temporary eyebrow lifting.

The target number of subjects for this clinical trial is set to 30 in a single group, without considering the statistical significance of hypothesis testing and dropout rate. Considering a dropout rate of 20%, the plan is to recruit a total of 38 subjects.

1. Evaluation of the effacacy is includes: Evaluation of eyebrow lifting photos by an independent evaluator, Patient Satisfaction (PS)
2. Evaluation of the safety is includes: Adverse events, vital signs, physical examination, and Visual Analogue Scale (VAS) after the application of medical devices for clinical trials

Eligibility Criteria:
Inclusion Criteria:

* 19 years old or older
* Voluntarily agreed to the clinical trial
* Who is need to eyebrow lifing

Exclusion Criteria:

* A history of cosmetic treatment (laser, light therapy, surgery, etc..) within the last 6 months
* A history of filler treatment (Collagen, AMA, etc...) within the last 6 months
* A history of Botulinum toxin injection within the last 6 months
* A history of treatment such as radiation therapy or chemotherapy, or history of malignat tumor
* A history of infections dermatitis, rash and shingles casued by thermal energy stimulation
* A history of treament with isotretinoin, retinoid preparations, or steroid preparations within the last 4 weeks
* Pregnancy
* Thos who participated in other clinical trials that affect the efficacy and safety evaluation of this clinical trial within 30 days of the screening date
The Effect of Lifestyle Treatment in Patients With Morbid Obesity

The effect of lifestyle treatment on physical capacity, maximal strength, eating behavior and quality of life in patients with morbid obesity (LIFETIME)

In this study, the investigators will investigate whether more intensive day-based lifestyle treatment process have a better effect on weight loss and health-related quality of life than a previous treatment. Investigators also want to investigate whether patients with good physical capacity (maximal oxygen uptake) and bone strength (maximum bone strength) before initiating treatment and / or after 3 and 6 months intensive training may have greater weight loss 1 and 2 years after treatment than patients with lower physical capacity and bone strength.

Eligibility Criteria:
Inclusion Criteria:

* Treatment seeking morbidly obese patients (BMI ≥ 40 kg/m2 or BMI 35 to 39.9 kg/m2 with ≥ 1 co morbidity) attending the Vestfold Hospital Trust.

Exclusion Criteria:

* Uncompensated heart failure
* Recent myocardial infarction or stroke (\<½ years)
* Severe arrhythmia or heart failure
* Unstable angina pectoris
* Renal failure
* Pregnancy
* Severe eating disorders
* Active substance abuse
A Randomized Controlled Study of the NEURESCUE Device As an Adjunct to Advanced Cardiac Life Support

The NEURESCUE device is the first intelligent balloon catheter for aortic balloon occlusion (ABO), an emergency technique that supercharges blood flow to the heart and brain within one minute from deployment.

The catheter-based device is delivered via the femoral artery, temporarily inflating a soft balloon in the descending to redirect blood flow towards the upper body.

The purpose of this study is to compare the clinical safety and performance of Advanced Cardiovascular Life Support (ACLS) versus ACLS in combination with Aortic Balloon Occlusion (ABO) using the NEURESCUE device in subjects with cardiac arrest.

Subjects will be randomized into two arms: ACLS treatment or ACLS + ABO treatment. Those in the ACLS treatment arm will receive standard of care treatment for cardiac arrest, while those in Arm 2 will receive ACLS in combination with ABO.

The NEURESCUE device is an aortic balloon catheter designed to temporarily occlude the aorta. During the treatment, the NEURESCUE Catheter will be placed in the descending aorta and be connected to the NEURESCUE Assistant. The NEURESCUE Assistant facilitates pressure-regulated inflation and deflation of the balloon.

Throughout the treatment, cardiac rhythm and return of spontaneous circulation (ROSC) will be monitored.

The subject will be monitored for a total of 4 visits, where a 90-days follow-up will account for the last visit.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤80 years
* Witnessed arrest
* CPR initiated within 7 min of arrest
* CPR time less than 40 min at enrollment
* Non-shockable rhythm

Exclusion Criteria:

* Traumatic cardiac arrest
* Known pregnancy
* Known terminal disease
* Known do-not-attempt-CPR order
* Known opposition to study participation
Incidence of HANA Conditions in HIV-infected Individuals

With the availability of effective anti-retroviral therapy, HIV-infected individuals are expected not to die of AIDS and have longer life expectancy. But at the same time, HIV-associated non-AIDS (HANA) conditions are becoming more important in their clinical management. It is currently uncertain whether patients started on different anti-retroviral regimens will have different incidence of HANA conditions.

This study aims to evaluate the incidence of various HANA conditions in a cohort of newly diagnosed HIV-infected individuals in Hong Kong initiating anti-retroviral treatment. The incidence of various HANA conditions will be evaluated for those receiving INSTI versus other non-INSTI-based regimens.

The HANA conditions evaluated will include 1. Hypertension 2. Diabetes and insulin resistance 3. Dyslipidemia 4. Lipodystrophy 5. Metabolic syndrome 6. Osteopenia and osteoporosis 7. Vitamin D deficiency 8. Renal impairment and kidney tubular dysfunction and 9. Liver fibrosis. Patients will be assessed prior to initiation of anti-retroviral therapy, and 48 weeks and 96 weeks after initiation of treatment. The incidence of development of each HANA condition will be determined and compared between those initiated different anti-retroviral regimens.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed HIV infection by HIV antibody or RNA test
2. Age ≥40 years old
3. Anti-retroviral treatment naïve
4. Agree to initiate anti-retroviral therapy (ART) as determined by in-charge HIV physician

Exclusion Criteria:

1. Pregnancy
2. Unable to give informed consent
Effect of Physical Exercise Program on Fetoplacental Growth

The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on fetoplacental growth.


Eligibility Criteria:
Inclusion Criteria:

* Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
* Being able to communicate in spanish
* Giving birth at Hospital Universitario de Torrejón, Hospital Universitario de Puerta de Hierro or Hospital Universitario Severo Ochoa (Madrid)

Exclusion Criteria:

* Multiparity
* Obstetrician complications
* Being interested in the study after 18 weeks
* Not having availability to attend to the physical exercise program
* Younger than 18 years old
* Older than 45 years old
Combination of Spinal-Epidural With General Anesthesia in Patients Undergoing Mega-Liposuction Surgery

The combination of general anesthesia to spinal and epidural techniques (CSEGA) proved to have a synergistic effect, thus, the use of sub-anesthetic doses can provide satisfactory anesthetic and analgesic results. CSEGA has several known advantages including appropriate postoperative analgesia, shows some benefit in the intraoperative blood loss control causing a decreased need for blood transfusion, rapid regain of the gastrointestinal actions and decreases the incidence of postoperative respiratory complications. Unfortunately, the drawbacks of using neuro-axial anesthesia in combination to general anesthesia will be not thoroughly introduced in many researches, thus, remain unclear.


Eligibility Criteria:
1. Inclusion criteria:

   * Patients aged from 18 to50 years.
   * ASA I-II.
   * undergoing elective liposuction surgery
   * BMI from 25 to 40 kg/m2
2. Exclusion criteria:

   * Patient refusal
   * ASA III-IV.
   * Patients aged less than 18 or more than 50.
   * Body mass index \>40.
   * Any contraindications to neuro-axial block such as coagulopathy or spine deformity
   * Chronic opioid consumption,
   * History of parenteral or oral analgesic intake within the last 48hours.
The Incidence, Clinical Characteristics and Outcome of Infective Endocarditis Among Intravenous Drug Abusers Versus Non-Drug Abusers.

We aim to describe the incidence of IVDA among patients presented with IE, describe their clinical, psychiatric and microbiological characteristics in comparison to non - IVDA, as well as the rate and types of complications and outcome, and responsiveness to medical treatment or surgical intervention.

Infective endocarditis (IE) is the infection of the endocardial surface of the heart mainly affecting the valves of the heart. It is still associated with very high morbidity and mortality all over the world despite various advances in diagnostic and treatment methods.

A few studies have shown that infective endocarditis represents less than 0.5% of adult cardiovascular admissions.While the overall incidence of IE has remained stable over the last several years, IE has increased in young people in parallel with injection drug use (IDU) behaviours and the growing opioid crisis.

According to recent guidelines , Intravenous (IV) drug use is considered a minor Duke criteria for the diagnosis of infective endocarditis.

Compared to the general population, intravenous drug abuse (IVDA) is associated with an up to 100-fold increased risk of IE through several mechanisms, including endothelial injury from injected particulate matter, direct injection of contaminated material, and drug-associated vasospasm leading to intimal damage and thrombus formation.

Also, IVDA is associated with HIV outbreaks, which is a well-known risk factor for IE. HIV-associated IE is associated with high rates of morbidity and mortality than non-HIV-associated IE.Because of its pathophysiology, IVDA-associated IE is more commonly right-sided. Beyond these known characteristics, however, literature on this topic is substantially limited, including the clinical and microbiological characteristics of these patients, rate and types of complications and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients (\>18 years) with definite or possible IE.

Exclusion Criteria:

* Patients with rejected diagnosis of infective endocarditis after workup, according to modified Duke's criteria.
MesoHep II: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis

Patients with end stage renal disease (ESRD) who use peritoneal dialyses with Physioneal(R) (Baxter A/S, Denmark) were allocated to inject either placebo or tinzaparin daily into the morning dialysis bag. Active medication, as well as placebo, was added for three months separated by a one month washout period. At the beginning and end of each treatment period peritoneal equilibrations tests (PE-tests), Kt/V, blood and dialysate samples were analyzed. We, the researchers at Ribe County Hospital, set out to examine inflammation (local and systemic), nutrition and ultrafiltration.


Eligibility Criteria:
Inclusion Criteria:

* End stage renal disease
* Peritoneal dialysis without complication for minimum of three months
* 18 years or above
* Informed consent

Exclusion Criteria:

* Known coagulatory defects including anticoagulation therapy
* Known bleeding tendency
* Peritonitis within two months prior to inclusion
* Pregnancy
* Breast feeding
* Active infection
* Non-informed consent
* Allergy to heparin or prior heparin induced thrombocytopenia
Three Dimensional Imaging and Wireless Technologies to Enhance Medical Care in Space

NASA has outlined the most urgent threats to life and health in manned spaceflight. One of the threats is the risk of trauma and acute medical problems. One of the most important provisions of acute and chronic medical services in space is the availability of high quality diagnostic imaging with the potential for either ground based or onsite interpretation. The principle diagnostic imaging modality for space crew use in space will be ultrasound. The aim of the study is as follows:

-To use state of the art 3 dimensional CT scanner to acquire images for segmentation and registration supplying a template to judge physiologic or pathologic changes observed in space with 3D ultrasound

In its Bioastronautics Critical Path Roadmap Baseline Document, NASA has outlined the most urgent threats to life and health in manned spaceflight currently in need of countermeasures development. This proposal specifically addresses one of four critical risks directly, that being the risk of trauma and acute medical problems, ID# 43 in the Clinical Capabilities discipline area. Critical for the provision of acute and chronic medical services in space is the availability of high quality diagnostic imaging, with either ground-based or autonomous interpretation. While development of novel sensor technology is actively pursued within the NSBRI, it is clear that for the foreseeable future, the principal diagnostic imaging modality for crew use in space will be ultrasound. For the past six years, the Cleveland Clinic has worked with NASA and NSBRI in a comprehensive program to develop ultrasonographic capabilities for use in manned space flight. Recent work has focused on enhancement of these capabilities, including 3D imaging and novel compression and registration techniques for assessing change over time in ultrasonic images. We now propose to extend these capabilities in very significant ways, capitalizing on dramatic recent advances in telecommunications and computerization to better address the critical countermeasures identified. Among the convergent trends in ultrasound that we seek to capitalize on are the following: most commonly applied diagnostic imaging test; Miniaturization; file storage; telemedicine; wireless telemetry; therapeutic use; real-time 3D.

We propose to extend our work with the following Specific Aims:

1. Extension of our longstanding research in 3D ultrasound with a recently developed third generation machine small enough to fit on the ISS, allowing more comprehensive imaging to be done with less operator expertise.
2. Utilization of a ultrafast 3D CT scanner to acquire full body 3D images for segmentation and registration with subsequently acquired 3D ultrasound images, modelling future missions for ground-based 3D CT or MRI could provide a template to judge physiologic or pathologic changes observed in space with 3D ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* Aortic regurgitation or aortic stenosis and scheduled for repair or replacement
Effect of Fermented Ginseng (GINST) on Sperm Motility

This randomized, double-blind, placebo-controlled study aimed to evaluate the effect of ginseng(GINST) supplementation for 12 weeks on sperm motility.

This multicenter, randomized, double-blind, placebo-controlled clinical trial was aimed to evaluate of sperm motility improvement effect of fermented ginseng(GINST). Experimental arm and control arm were randomly assigned among the volunteers who met the inclusion criteria: men between the ages of 18 and 60 who had sperm motility of less than 32%.

To experimental arm, capsules including 160mg of fermented ginseng(GINST) ingredients will be provided for 12 weeks. To control arm, capsules of the same shape and weight as GINST capsules will be provided. These capsules are made of a cellulose component.

Primary outcome is sperm motility. Secondary outcome are \<Brief Male Sexual Function Inventory\> , \<Fatigue Severity Scale\>, and \<the Short Form (36) Health Survey\> measured at baseline and end of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Male between 18 and 60 years old
* Men who have agreed to participate in this trial before the start of the study and who have written an informed consent

Exclusion Criteria:

* Those who are diagnosed and treated for hypertension (systolic blood pressure\> 140mmHg and diastolic blood pressure\> 90mmHg)
* Patients with a history of chemotherapy for malignant tumors
* Patients with a history of taking testosterone or antiandrogens within 1 month
* BMI\> 30 or BMI \<18
* Those who have the following results in the blood test: AST(aspartate aminotransferase ), ALT(Alanine transaminase) \> 2 times the upper limit of reference range; Serum Creatinine\> 2.0 mg / dl
* Those who ingested drugs (eg, folic acid, L-carn, HCG(human chorionic gonadotropin ), FSH(Follicle-stimulating hormone), Clomiphene, etc.) that have an effect on sperm motility within 2 weeks before the screening day.
* Persons who have received antipsychotic medication within 2 months before the screening test
* Those who have history of alcoholism or substance abuse