cyrilzakka/clinical-trials huggingface dataset:
Lycopene Following Aneurysmal Subarachnoid Haemorrhage

In this study the investigators wish to explore the potential neuroprotective effects of acute oral supplementation of lycopene, a natural anti-oxidant derived from tomatoes, on cerebral vasospasm and autoregulation, and examine whether any improvements translate into a reduction of biochemical markers of vascular injury and inflammation a decrease in the prevalence of secondary strokes following subarachnoid haemorrhage.


Eligibility Criteria:
Inclusion Criteria:

* Age: \> 18 years old,
* Confirmed aneurysmal subarachnoid hemorrhage (aSAH),
* Time from ictus \< 96 hours

Exclusion Criteria:

* Age: \< 18 years old,
* Non-aneurysmal SAH,
* Time from ictus \> 96 hours,
* Severe carotid atherosclerotic disease (≥70%)
* High-dose statin therapy (\>80 mg/day fluvastatin; \>40 mg/day simvastatin; \>40 mg/day pravastatin; \>10 mg/day atorvastatin; \>10 mg/day rosuvastatin 28),
* Allergy or hypersensitivity to tomatoes and tomato products and history of any other significant atopy/allergy (e.g. soy, whey, lutein, lecithin)
Registry Study for the Observation of Patients With ESUS/Cryptogenic Stroke

Up to know, there is no clear diagnostic and therapeutic pathway for patients with embolic stroke of undetermined source (ESUS). This prospective registry study, which follows up adult ESUS patients for 36 months, is intended to provide important data for the detection of an individual approach in ESUS patients based on a structured diagnostic and therapeutic pathway.

The open-label, academic, prospective, monocentric, observational registry-study (Catch-up-ESUS registry study) started in 01/2018. All ESUS-patients (≥18 years) treated in our hospital are included and will be followed up for three years. Depending on age (\< 60 years or ≥ 60 years), the patients are processed according to a standardized treatment algorithm designed interdisciplinary by neurologists and cardiologists. An insertable cardiac monitor (ICM) is implanted in all of them by default. Patients \< 60 years without evidence of atrial fibrillation and co-existing PFO are planned for PFO closure within 6 months after stroke.

Eligibility Criteria:
Inclusion Criteria:

* Embolic stroke of undetermined source or cryptogenic stroke; defined as: non-lacunar brain infarction without proximal arterial stenosis or cardioembolic source or other etiology (e.g. vasculitis, cervical artery dissection)
* ≥18 years
* written consent to participation in the study register by the patient or the legal guardian or authorised representative at the time of inclusion in the study
Efficacy and Tolerability of Antistax® in Male and Female Patients Suffering From Chronic Venous Insufficiency

Study to assess the efficacy and tolerability of Antistax® film-coated tablets in patients with chronic venous insufficiency (CVI, Clinical condition, Etiology, Anatomic location, Pathophysiology (CEAP) Classification: Clinical Class 3, or 4a)


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18 years of age or older
* CVI, Clinical Class 3 (oedema) or 4a (mild skin changes ascribed to venous disease, e.g. pigmentation), according to the CEAP classification
* Willing and able to give written informed consent prior to participation in the study

Exclusion Criteria:

Concomitant diseases:

* Decompensated cardiac insufficiency
* Oedema not due to venous disease of the legs (e.g., latent cardiac insufficiency, renal insufficiency, lymphoedema, etc)
* Peripheral arterial disease (ankle/arm pressure index \< 0.9)
* Current acute phlebitis or thrombosis
* Renal insufficiency (serum creatinine \> 1.5 mg/dl)
* Liver disease (SGPT \> 3x upper limit of normal)
* Other diseases: hyper- or hypocalcaemia, malignancies
* Anamnestic indications of diabetic microangiopathy or polyneuropathy
* Drug and/or alcohol abuse
* Severe climacteric complaints: changes in, or initiation with post-menopausal hormone replacement therapy within the last 3 months
* Immobility
* Avalvulia
* Klippel-Trénaunay-Weber-Syndrome (Naevus varicosis osteohypertrophicus, Haemangiectasia hypertrophicans)
* State after pulmonary embolism
* Recognised hypersensitivity to the trial drug ingredients
* Current florid venous ulcus
* Clinical indication for a necessary, specific phlebologic acute treatment, e.g. compression treatment, phlebectomy, etc.

Previous treatments:

* Patients who are on compression therapy and/or are wearing support stockings and who optimally benefit from these measures
* Treatment with venous drugs within the last 2 weeks prior to the intake of study medication
* Changes in or unstable response to treatment with theophylline, diuretics, cardiac glycosides, ACE inhibitors, calcium antagonists, or laxatives within the last 2 weeks prior to the intake of study medication

Concomitant treatment/non-drug therapy exclusion criteria:

* Other venous drugs apart from the trial medication
* Venous surgery or sclerotherapy within the last 12 month at the leg used for volumetry
* Extensive use of laxatives
* Major surgery requiring full anaesthesia

Other exclusion criteria:

* Previously studied under this protocol
* Participation in another clinical trial within the previous 90 days or during the present study
* Patient is investigator, co-investigator, or study nurse in this study
* Pregnant or nursing women or inadequate birth control methods (this applies to females of childbearing potential only)
* Patients considered as mentally ill as well as unable to work or with limited working ability, or unable (or only partially able) to follow the spoken or written explanations concerning the trial
* Patients in a bad general health state according to the investigator's judgement
Effects of Vitamin D in Patients With Breast Cancer

This protocol is a randomized, phase 2 "window of opportunity" trial assessing the biological effects of short term oral vitamin D administration on breast cancer clinical and translational markers in patients awaiting surgery at the Ottawa Hospital. It takes advantage of the current wait times (2-8 weeks) for breast cancer surgery as a "window of opportunity" to rapidly assess biological changes with vitamin D intake.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed female primary breast cancer patients whose surgery is planned for the next 2-8 weeks without neoadjuvant therapy as assessed by multidisciplinary team
2. Age ≥18 years
3. Clinically palpable tumour(s) (greater than or equal to 2 cm)
4. Normal serum and urine calcium and serum PTH values at baseline (as defined by Ottawa Hospital)
5. Written informed consent for study

Exclusion Criteria:

1. Patients with recurrent or metastatic breast cancer
2. History of neoadjuvant hormonal therapy, chemotherapy, or radiation therapy in the last 6 months for their breast cancer or any other cancer treatment
3. ECOG performance Status \> 2
4. Hypercalciuria on initial baseline urine, defined as Ca/Creatinine Ratio\> 1.0
5. Current or previous history of urolithiasis or hyperparathyroidism
6. Abnormal hepatic function according to Ottawa Hospital norms (Total Bilirubin \>2x upper limit of normal, ALT/AST \>3x upper limit of normal)and/or abnormal renal function (Creatinine \> 150 µmol/L)
7. History of granulomatous disease such as tuberculosis or sarcoidosis.
8. Intake of Vitamin D (cholecalciferol) supplement ≥ 2000 IU/day within the last 2 months
9. Inability to comply with a study protocol in the opinion of the investigator (such as abuse of alcohol, drugs or psychotic states).
Vitamin D Deficiency as Independent Predictor for Plaque Vulnerability

Role of vitamin D in cardiovascular disease is controversial. Here the investigators aimed to investigate the association of vitamin D deficiency and carotid plaque morphology as well as outcome of participants with high-grade carotid artery stenosis undergoing carotid endarterectomy.

332 consecutive participants undergoing carotid endarterectomy for symptomatic or asymptomatic carotid artery stenosis, were prospectively included in the study, and vitamin D levels were determined prior to surgery using chemiluminescence-immunoassay.

Role of vitamin D in cardiovascular disease is controversial. Here the investigators aimed to investigate the association of vitamin D deficiency and carotid plaque morphology as well as outcome of participants with high-grade carotid artery stenosis undergoing carotid endarterectomy.

332 consecutive participants undergoing carotid endarterectomy for symptomatic or asymptomatic carotid artery stenosis, were prospectively included in the study, and vitamin D levels were determined prior to surgery using chemiluminescence-immunoassay.

There is insufficient data on cardiovascular outcome in participants with CAS and vitamin D deficiency. Vitamin D would be an easily modifiable factor.

Primary goal was to investigate the influence of vitamin D levels on plaque vulnerability, major adverse cardiovascular events (MACE) and all-cause mortality in patients with carotid artery disease undergoing carotid endarterectomy.

Eligibility Criteria:
Inclusion Criteria:

* Carotid arteriostenosis
* Patient eligible for carotid artery surgery

Exclusion Criteria:

* Oncologic disease
* Patients with hemorrhagic, lacunar or cardioembolic stroke
Bioequivalency Study of Amlodipine Besylate Tablets, 10 mg of Dr. Reddy's Under Fasting Conditions

The purpose of this study is to determine the pharmacokinetics and bioequivalence of amlodipine besylate formulations under fasting conditions.

This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Tablets 10 mg of Dr. Reddy's versus Norvasc 10 mg tablets administered as 1 x 10 mg tablet in healthy volunteers with a washout period of 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects between 18 and 45 years of age inclusive.
* Informed of the nature of the study and given written informed consent.
* Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weigh at least 115 (Appendix I and Appendix II).

Exclusion Criteria:

* If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the three treatment periods. Females must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of themselves or their partners or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
* Hypersensitivity to amlodipine besylate (Norvasc®) or related calcium channel blockers).
* Any history of a clinical condition that might affect drug absorption, metabolism or excretion.
* Recent history of mental illness, drug addiction, drug abuse or alcoholism.
* Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
* Received an investigational drug within the 4 weeks prior to study dosing.
* Currently taking any prescription medication, except for oral contraceptives, within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or -herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
* Regular tobacco use in the 6 months prior to study dosing.
TEAM: Testosterone Supplementation and Exercise in Elderly Men

The purpose of this study is to evaluate the effects of testosterone supplementation (AndroGel) on body composition, strength, endurance, cognition, and function in older men.

Studies suggest that testosterone (T) replacement in healthy elderly men has beneficial effects on body composition, muscle, bone, memory, and behavior, but the risks of chronic treatment, especially on the prostate, heart, and sleep quality, are not entirely clear. Therefore, it is most desirable to supplement into the lowest "effective" range in elderly men. However, the effects of lower than usual replacement T doses have not been well studied. Furthermore, the possible important interaction of exercise to enhance the positive effects of T supplementation, yet mitigate the possible side effects, has not been studied in older men.

This one-year study will enroll 150 men with low-normal to slightly below normal serum total T levels. Participants will be randomized into one of 6 treatment groups to receive T supplementation (AndroGel) of 25mg/day, 50 mg/day or a placebo crossed with progressive resistance training (PRT) exercise 3 times a week versus none. At the end of the study, participants in the exercise-control group will be offered PRT.

Please see link below for updated version of full protocol.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, untrained men 60 years or older with low-normal testosterone levels (200-350ng/dL)
* Must reside in the Denver metro area

Exclusion Criteria:

* Prostate/breast cancer
* Unable to exercise safely
* severe obesity (\>34 body mass index \[BMI\])
* Polycythemia
* Diabetes
* Use of drugs that could affect T levels
* Cognitive dysfunction (MMSE less than 24)
* PSA above the age-adjusted normal level or AUA greater than 19
* Unable to pass stress test due to active CAD
Prevention of Nausea and Vomiting in Patients After Surgery

Postoperative nausea and vomiting (PONV) is a common problem after general anesthesia. The incidence can be as high as 80 percent in high-risk patients. Investigators designed this randomized, double- blind, single-center study to compare the efficacy of the combination of dexamethasone with ondansetron and dexamethasone with aprepitant undergoing laparoscopic surgery.

Seventy American Society of Anesthesiologist (ASA) physical class I-II, age 18-60 years patients scheduled for laparoscopic surgery were included in this study. Anesthesia was induced with propofol, fentanyl, and rocuronium, and maintained with sevoflurane in oxygen / air mixture in all patients. Remifentanil was continuously infused during surgery. Patients were randomly divided into two groups. Patients in the dexamethasone and aprepitant group (group DA, n=35) received 40 mg aprepitant orally 1 to 2 hours before induction of anesthesia and 2 ml saline intravenous (iv) within the last 30 minutes of surgery. Patients in the dexamethasone and ondansetron group (group DO, n=35) received an oral placebo identical to aprepitant 1 to 2 hours before induction of anesthesia and 4 mg ondansetron iv within the last 30 minutes of surgery. All patient received iv 8 mg dexamethasone after induction of anesthesia.

PONV and postoperative opioid consumption were assessed for 24 hours postoperatively. The blindly evaluated primary outcome was complete response. The secondary outcomes were incidence of nausea, retching or vomiting, the need of rescue antiemetic and opioid consumption within 24 hours after surgery. Statistical analyses were performed using Mann-Whitney U test, Chi-square test, and Fisher's Exact test. P\<0.05 was considered statistically significant.Investigators hypothesized that the antiemetic efficacy of the aprepitant and dexamethasone combination is superior compared with ondansetron and dexamethasone combination following the laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* 18 Years to 60 Years
* ASA (American Society of Anesthesiologist) physical status I or II
* Patients undergoing laparoscopic gynecologic surgery or laparoscopic cholecystectomy

Exclusion Criteria:

* Hypersensitivity or contraindication to the study medications,
* Antiemetic drug or steroid use within 24 hours before anesthesia,
* History of diabetes mellitus,
* History of motion sickness or postoperative nausea and vomiting,
* Pregnancy,
* Breast feeding
Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) on for Insomnia and Mental Health of Prisoners

Insomnia is highly prevalent in prisoners and is a risk factor for poor mental well-being, depression, suicidality and aggression, all common concerns in this vulnerable population. Improving sleep management options in prison offers the potential to impact positively on a number of these common risk factors. The study aim is to asses psychological intervention for insomnia in prisons.


Eligibility Criteria:
Inclusion Criteria:

* Are at least 18 years of age
* Clinical level of Insomnia (more than 10 on ISI)
* Meets criteria for Insomnia according to DSM-5 Insomnia Disorder
* Can speak, understand, and write in Persian
* Male

Exclusion Criteria:

* Currently receiving psychological treatment for Insomnia
* presence of a rapidly progressing neurological or medical disorder
Epidemiology of In-hospital Acute Kidney Injury

Retrospective observational study to investigate acute kidney injury (AKI) epidemiology and outcomes in patients hospitalized in University Hospital San Martino, Genova, Italy.

A retrospective observational study was designed to investigate acute kidney injury (AKI) epidemiology and outcome in patients hospitalized in University Hospital San Martino, Genova, Italy.

All data will be extracted from the hospital electronic database. The investigators will evaluate demographic, clinical and laboratory data, including age, sex, serum creatinine (sCr), sodium and electrolytes, intensive care unit (ICU) admission, length of hospital stay, death, comorbidities and primary diagnosis codes at the hospital discharge (using International Classification of Diseases-ICD-9- codes).

The investigators will include also patients affected by Coronavirus disease 19 (COVID-19).

The primary endpoint will be to describe AKI epidemiology, secondary endpoints will be to evaluate AKI-related risk factors and clinical outcomes, such as length of stay and mortality.

Moreover, the investigators will describe the differences in the outcome and treatments of AKI patients in the medical wards and ICU.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to University Hospital San Martino, Italy
* We'll include also patients affected by Coronavirus disease 19 (COVID-19).

Exclusion Criteria:

* Hemodialysis patients
Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)

Phase 2 open label, randomized, active controlled, dose-ranging trial in adults with Center Involved - Diabetic Macular Edema (CI - DME)

This Phase 2 trial is an open label, randomized, active controlled, dose-ranging trial to allow for preliminary safety and efficacy data on subretinal (SR) delivery of RGX-314 in participants with CI - DME

Eligibility Criteria:
Inclusion Criteria:

* Type I or Type II diabetes mellitus with center involving diabetic macular edema with previous treatment
* HbA1c ≤12%
* BCVA in study eye 78 to 25 ETDRS letters (\~20/32 to 20/320) at screening
* Decreased visual acuity attributable primarily due to CI - DME
* Demonstrate clinical response to aflibercept injection in the study eye
* Provide written informed consent

Exclusion Criteria:

* Women of childbearing potential
* Neovascularization in the study eye from a cause other than DR
* Evidence in the study eye of optic nerve pallor on clinical examination
* History of pan retinal photocoagulation in the study eye
* Any concurrent ocular condition in the study eye other than CI-DME that could require surgical intervention within 6 months or any condition in the study eye that may increase the risk to the participant, require either medical or surgical intervention during the study to prevent or treat vision loss, or interfere with the study procedures or assessments
* Presence of an implant in the study eye at screening (excluding intraocular lens)
* Any condition in the investigator's opinion that could limit VA improvement in the study eye
* Active or history of glaucoma, steroid response, or ocular hypertension
* Any prior intravitreal steroid injection in the study eye within 6 months prior to screening, administration in the study eye of Ozudrex® within 12 months prior to screening, or administration in the study eye if Iluven® within 36 months prior to screening
* Diabetic macular edema diagnosis ≥ 7 years
* History of chronic renal failure requiring dialysis or kidney transplant
* Participation in any other gene therapy study or receipt of any investigational product within 30 days prior to enrollment or 5 half-lives of the investigational product, whichever is longer, or any plans to use an investigational product within 6 months following enrollment

Note: Other inclusion/exclusion criteria apply
Safety and Efficacy of Autoimmune Cell Therapy for Patients With Hepatocellular Carcinoma

In this study, safety and effects of IPM001 vaccine on human hepatocellular carcinoma are going to be investigated, IPM001 is a neoantigen/tumor-specific antigen sensitized autoimmune cell injection


Eligibility Criteria:
Inclusion Criteria:

* understand and voluntarily sign a written informed consent;
* Age: from 18 to 75 years, No restriction on gender;
* Patients must have primary hepatocellular carcinoma;
* Clinical stage: stage Ia\~III a;
* Child-pugh score ≤7;
* HLA-A02 and consistent with ≥1 NeoAg or ≥2 aeTSA peptide bank;
* ECOG PS score: 0\~2;
* Laboratory values as follow:
* White blood cell count ≥ 3×109/L; Neutrophils: more than 1.5 × 109/L; Hemoglobin: more than 85g/L; Platelets: more than 5 × 1010/L; Total bilirubin:≤2 × ULN; Serum AST(GOT) and ALT(GPT)≤2.5 × ULN; Albumin ≥3.0 g/dL (30 g/L); Serum creatinine: less than 1.5 × ULN; Coagulation time was basically normal, PT extension ≤4s; No serious cardiopulmonary disease;
* Blood collection body weight: male \> 50 kg, female \> 45 kg;
* No obvious hereditary diseases;
* Expected survival: more than 6 months;

Exclusion Criteria:

* Patient has known distant organ metastasis;
* Suffer from lymphoma or leukemia or MDS (myelodysplastic syndrome), etc.;
* Woman be pregnant or lactating;
* Suffer from mental or neurological diseases that are resistant to control;
* The investigator judges that it is not suitable to participate in this clinical research (such as poor compliance, etc.);
* Patients infected with human immunodeficiency virus (commonly known as AIDS) or Treponema pallidum (commonly known as syphilis);
* Patients with a history of other malignant tumors in the past 5 years;
* Organ transplantation or Myelosuppression;
* History of drug abuse or alcohol abuse;