cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Delirium Prevention in Critically Ill Patients

Haloperidol is prescribed in high risk ICU patients concerning delirium (50% or more chance to develop delirium detected with the delirium prediction model PRE-DELIRIC, or patients with history of dementia or alcohol abuse)since the delirium protocol is changed and haloperidol is added as a prevention treatment we are gathering information what the effect is on several aspects of delirium

Measurement the effect of haloperidol as delirium preventive intervention. Determining effect on:

- delirium incidence in the ICU - different subtypes of delirium - delirium free days in 28 days - days on the ventilator - length of stay on the ICU and In-Hospital - 28-day mortality - incidence of unexpected removal of tubes, and effect between different groups of patients. Safety of haloperidol concerning QT-time, extrapyramidal symptoms.

Data are compared with the data of a historical cohort

Eligibility Criteria:
Inclusion Criteria:

* Patients With Predicted Delirium Chance of \>50% or history of dementia or alcohol abuse and treated with haloperidol

Exclusion Criteria:

* CAM-ICU is Not Applicable
* Patients Admitted 24hours or Shorter on the ICU, Patients Who Are Delirious Within 24 Hours After ICU Admission
* patients whereby haloperidol is contra-indicated
A CCTA Image Assisted Triage Software for the Assessment of Patients With Suspected Coronary Artery Disease

The goal of this clinical trail is to evaluate the effectiveness and accuracy of the CCTA image assisted triage software(DeepVessel® Cardisight, Keya Medical.) for the triage of patients with suspected coronary artery disease.

The CCTA images collected by each center within a certain period of time would be screened, desensitized, and then evaluated by the software and independent expert group respectively, to evaluate the effectiveness and accuracy of the coronary CT angiography image stenosis assisted triage software developed by Koyal Medical Technology Co.

Experiment group: Evaluated by the software Independent expert group: Evaluated by experts (≥5 years of CCTA experience required)

Eligibility Criteria:
Inclusion Criteria:

1. CCTA images acquired by CT detectors need to meet the following requirements:

   * Check Modal = CT
   * Number of detector rows ≥ 64 rows
   * Layer thickness ≤1mm
   * Layer spacing ≤1mm
   * Pixel pitch ≤ 0.5mm
   * Ball tube voltage ≥ 70kV
   * Number of layers ≥ 100 layers
2. CCTA image quality score ≥ 3 (5-point Likert scale).

Exclusion Criteria:

1. Severe coronary artery calcification, which in the judgment of readers affects the stenosis adjudicator;
2. Previous percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG);
3. Congenital anomalies of coronary artery origin or other malformations;
4. Coronary artery occlusive lesions;
5. Implantation of the pacemaker, internal defibrillator electrode, or prosthetic heart valve.
Combination of Intravitreal Ranibizumab With or Without Macular Laser Photocoagulation for ME Secondary to BRVO

To investigate the efficacy of laser photocoagulation combined with ranibizumab intravitreal injection in macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in long term.

To investigate the efficacy of ranibizumab intravitreal injections-driven by achieving vision acuity stabilization compared to combination with laser photocoagulation in Chinese patients with visual impairment in ME due to BRVO.

The result of the trial will be used to support new therapy in the BRVO in China.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Male or female Chinese patients ≥ 18 years of age with BRVO
3. Visual impairment due to ME secondary to BRVO in at least one eye with BCVA score between 73 and 24 and at least 24 letters in the other eye

Exclusion Criteria:

1. Pregnant or nursing (lactating) women or women of child-bearing potential without using effective contraception
2. Stroke or myocardial infarction less than 3 months prior to screening visit
3. Renal failure or creatinine levels \> 2.0 mg/dl
4. Uncontrolled hypertension
5. Active ocular infection or intraocular inflammation in any eye
6. Neovascularization of the iris or neovascular glaucoma in any eye
7. History of uveitis or vitreomacular traction in any eye
8. Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye
9. Glaucoma or intraocular pressure (IOP) ≥ 24 mmHg in study eye
10. Active proliferative diabetic retinopathy in study eye
11. Use of other investigational drugs within 30 days and systemic vascular endothecial growth factor (VEGF) antagonism drugs within 6 months prior to baseline visit
12. Prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye
13. History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening
14. History of vitrectomy in study eye
15. Other protocol defined inclusion /exclusion criteria may apply
Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment

The purpose of this study is to show equivalence with regard to the number of oocytes retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing IVF/ICSI


Eligibility Criteria:
Inclusion Criteria:

* Infertility due to tubal factor and/or male factor
* Age between 20 and 35 years with regular menstrual cycles of 21-35 days
* First or second cycle in the present series of ART
* BMI (body mass index) ≥ 18 ≤ 30 kg/m2
* Basal FSH (follicle stimulating hormone) \< 10 IU/L (cycle day 2-5)
* E2 (estradiol) levels \< 50pg/mL (cycle day 2)
* AMH (anti-mullerian hormone) ≥ 1.0 ng/ml
* Antral follicle ≥ 4 to ≤ 15 follicles (both ovaries)
* Presence of both ovaries and normal uterine cavity
* Informed consent

Exclusion Criteria:

* Presence of pregnancy
* Hypersensitivity to follitropin alfa
* Ovarian cysts
* History of ≥2 succeeding ART (assisted reproductive technology) cycles IVF (in vitro fertilization) and/or ICSI (Intracytoplasmic sperm injection) before the study cycle
* Previous history of severe ovarian hyperstimulation syndrome
* Presence of polycystic ovaries (PCO)
* Presence of endometriosis and hydrosalpinx
* Presence of uterine disorders
* History of poor (\< 4 oocytes) or hyper (\> 25 oocytes) responses to FSH treatment at dose 150 IU and GnRH-antagonist (gonadotropin-releasing hormone) protocol
* Premature ovarian failure
* Ectopic pregnancy (3 month before the study cycle)
* Presence of clinically significant systemic disease
* Presence of chronic cardiovascular, hepatic, renal or pulmonary disease
* Presence of endocrine disorder
* Neoplasia
* Male infertility without mobile spermatozoa in the ejaculate, that need MESA (Microsurgical epididymal sperm aspiration)/TESE (testicular sperm extraction)/TESA (testicular sperm aspiration)
* Smoking \> 10 cigarettes/day
* Narcomania, alcoholism
* Planned PGS (preimplantation genetic screeneing) /PGD (preimplantation genetic diagnosis)
Cardioprotective Properties of Natural Anti-Platelet Activating Factor Extract From Winery By-products in Healthy Women

The purpose of this study is to investigate the anti-platelet and anti-inflammatory properties of a winery by-products extract as well as to detect extract compounds and their metabolites in biological fluids. The study is a randomized, double-blind, crossover, placebo controlled postprandial study in healthy women.

The well-known cardioprotective and metabolic effects of wine consumption are mainly attributed to its micro-constituents. Grape pomace (GP) is a by-product of the winemaking process and consists mainly of skins and seeds. Winery by-products are a cheap and rich source of similar-to wine micro-constituents, which can be used either to enrich other foods or to be included in food supplements targeting the prevention or partially the therapy of cardiovascular diseases.In this line, our previous results revealed the potent in vitro anti-platelet effects of a specific ethanol-water extract rich in Platelet-Activating Factor inhibitors from winery by-products.

The purpose of this study is to investigate the in vivo anti-platelet and anti-inflammatory properties of the specific winery by-products extract as well as to detect the extract compounds and their metabolites in biological fluids.

Therefore a randomized double-blind, crossover, placebo controlled postprandial study in healthy women will be implemented. For this purpose, 15 healthy women will participate in the protocol. The two daily trials will take place during specific days based on their menstrual cycle. Three days before each blood collection the volunteers will be instructed to abstain from food and beverages rich in phenolic compounds and their dietary intake will be recorded (three 24h recalls and one food frequency questionnaire). The blood collections will be carried out after 8h fasting. At trial day, the volunteers will bring the first morning urine sample and anthropometric measurements will take place (weight, height, waist/hip circumference, bioelectrical impedance). Then a venous catheter will be placed and after 10 minutes the fasting blood will be collected. Volunteers will proceed to the consumption of a standardized meal (1131 kcal, 19.7% carbohydrates, 11.2% protein, 66.7% fat) along with the capsules (study extract or placebo). The type of the capsules consumed (study extract or placebo) will be randomized and blind during the two intervention days for both volunteers and investigators. Blood will be drown after the meal consumption and for the next 6h (every 30minutes for the first 4h and every 1h for the next 2h). Serum, plasma, platelet-rich plasma, leukocyte-rich plasma and urine samples will be isolated at certain time points during trial days so that the anti-platelet, anti-inflammatory and antioxidant effects of the study extract can be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Females
* BMI: 22-32 kg/m2

Exclusion Criteria:

* Systematic medication
* Chronic disease conditions
* Specific dietary conditions (vegeterian, vegan...)
* Eating disorders
A Phase 1, First-in-human Study of VX-668

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VX-668 at various doses.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Participants of age between 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
* A total body weight of more than (\>)50 kg
* Nonsmoker or ex-smoker for at least 3 months before screening

Key Exclusion Criteria:

* Any condition possibly affecting drug absorption
* Females of childbearing potential

Other protocol defined Inclusion/Exclusion criteria may apply.
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia

This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18 to 65 years of age, inclusive
* Patients with chronic kidney disease on dialysis
* ESA naïve with Hb \< 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
* Adequate irons status as judged by the treating physician

Exclusion Criteria:

* Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
* Clinically significant concomitant disease or disorder as defined by protocol
* Clinical suspicion of pure red cell aplasia (PRCA)
* Planned elective surgery during the study period , except for cataract surgery or vascular access surgery
* Transfusion of red blood cells in the previous 2 months
* Pregnant women
* Contraindications for Mircera according to local prescribing information or as judged by the investigator
Change of Fructose to Fat in South Asians

The purpose of this study is to determine whether hepatic de novo lipogenesis (DNL) in response to the ingestion of a mixture of glucose and fructose is greater in South Asians compared to controls (Caucasians).

South Asians, who originate from the Indian subcontinent and make up one-fifth of the world's population, are among the highest number who suffer from heart disease and diabetes. The results of many research studies suggest that genes play a role in developing heart disease and diabetes that is made worse by the diet in the United States. Fructose is a sugar widely used in the American diet, and when consumed, it is taken up by the liver and changed into fats through a process called de novo lipogenesis (DNL). The current study will compare this change into fats in the liver between South Asians and Caucasians. The participants will be screened on the initial visit, and on the second visit, the DNL response will be measured in the blood over four hours after drinking one sweetened beverage, containing half glucose, half fructose, similar to a soft drink. We expect that DNL in response to fructose intake is higher in South Asians when compared to Caucasians and may partially explain why South Asians have earlier heart disease and diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18-35 years of age.
* South Asian or Caucasian descent through self-identification (South Asians are to have both biological parents with ancestry from India, Pakistan, Sri Lanka, Nepal and Bangladesh and no known non-South Asian ancestry in parents; Caucasians are to have both biological parents who self-identify as Caucasian and no known non-Caucasian ancestry in parents).
* Body mass index (BMI) 18.0-24.9 kg/m2 with no history of obesity.
* Fasting glucose \<100 mg/dL, 2h glucose oral glucose tolerance test (OGTT) \< 140 mg/dL.
* triglycerides (TG) \<200 mg/dL, HDL cholesterol (HDL-C) \>30 mg/dL, LDL cholesterol (LDL-C) \<160 mg/dL.
* Willing and able to stop fish oil, fiber supplement, other non-prescribed vitamins/supplements for 1 week prior to visit #2 until completion of study.
* Willing to not drink alcohol for 24-hours before visit #2.
* Willing and able to provide informed consent.

Exclusion Criteria:

* History of diabetes or other endocrine disorder, hepatitis or other liver disorder, HIV, or autoimmune disease.
* Medication(s) known to affect lipids, including hormonal contraceptives.
* Recent acute illness
* Gastrointestinal disease resulting in significant gastrointestinal dysfunction or malabsorption.
* Cigarette smoking
* History of ethanol abuse (current intake \>2 drinks/day) or illicit drugs.
* History of severe psychiatric illness
* If female, pregnant or breastfeeding
* Participation in an investigational drug study within one month of screening.
* Unusual diet or extreme level of physical activity
* Have any other condition, which in the opinion of the investigator, should prohibit the participation in the study
A Trial to Evaluate the Safety of Niraparib Tablets in Adult Female Participants With Advanced or Relapsed Epithelial Ovarian Cancer

The goal of this clinical trial is to learn about the safety profile of niraparib in adult female participants for the treatment of advanced or relapsed epithelial ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female participants with ≥18 years of age, able to understand the study procedures and agree to participate in the study by providing written informed consent.
* Histologically confirmed epithelial ovarian cancer.

  * Eligible for active study drug treatment according to the approved label - as monotherapy for the maintenance treatment of adult participants with advanced epithelial (International Federation of Gynecology and Obstetrics \[FIGO\] stage III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
  * as monotherapy for the maintenance treatment of adult participants with platinum-sensitive relapsed high grade serious epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
* Laboratory complete blood count (CBC) criteria (Absolute neutrophil count ≥1,500/microliters \[μL\]; Platelets ≥100,000/μL; Hemoglobin ≥9 grams per decilitre \[g/dL\]).
* Adequately controlled hypertension basis on investigator's discretion.
* Women of childbearing potential must be ready to use contraceptive measures to avoid pregnancy during study period and until 180 days after the last dose.

Exclusion Criteria:

* Participant is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for up to 180 days after the last dose of study treatment.
* Participant had known, active hepatic disease, known case of end-stage renal disease (ESRD), known case of serious, uncontrolled medical disorder, any known history or current diagnosis of Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML).
* Any previous polymerases inhibitor (PARPi) treatment.
* Participant with concomitant serious uncontrolled medical illness.
* Participant is receiving niraparib for use that is not according to the approved label.
* Participant with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug.
* Participant with a previously or currently diagnosed MDS/ AML or pneumonitis.
* Participants who have not recovered sufficiently from prior surgery or anticancer treatment.
* Participants who have known history of hepatitis B or hepatitis C.
* Participant with active infection such as tuberculosis (TB) Prior/concurrent clinical study experience.
* Participation in another clinical study with a study drug administered in the last 3 months.
* Judgment by the investigator that the participant should not take part in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.
* Previous enrolment in the present study.
The Outcome of Pre-transplant Bladder Cycling in Patients With Defunctionalized Bladder

The aim of this study is to evaluate the efficacy of pre-transplant programmed bladder cycling for patient with defunctionalized urinary bladder

Kidney transplantation still remains the best treatment for end-stage renal disease (ESRD). Indeed, increasing numbers of patients are referred for transplantation, but there has been no concomitant increase in the supply of kidneys from the traditional donor pool. Many potential recipients awaiting transplantation, therefore must undergo dialysis for a long time. Regarding the detrimental effect of long-term dialysis associated with oliguria or anuria on the lower urinary tract, and especially in bladder, the interruption of physiological cycle of storage and voiding brings to a situation called Defunctionalized Bladder (DB) in which the bladder capacity became smaller in size. (Errando et al 2018).

In this study we will evaluate the outcome of renal transplantation into a defunctionalized bladder by comparing direct transplantation into this defunctionalized bladder and pre-transplant programmed bladder cycling.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 16 years and older.
2. ESRD patients maintained on hemodialysis for more than 12 months.
3. Have oliguria or anuria
4. reduced bladder capacity (less than 100 ml) assessed by cystogram.

Exclusion Criteria:

* 1- Previous bladder or pelvic surgery or procedure having affected the bladder function.

  2- Neurogenic bladder dysfunction. 3-Patients with history of lower urinary tract symptoms before developing renal failure.

  4-Those with lower urinary tract disease resulting in renal failure.
CONcomitant eValuation of Epicor Left atRial Therapy for AF

The purpose of this study is to test the safety and efficacy of the Epicor LP Cardiac Ablation System for treating permanent atrial fibrillation during concomitant open chest and/or open heart surgery for one of more of the following procedures: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, coronary artery bypass surgery or patent foramen ovale (PFO closure).


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* Permanent AF defined as continuous AF lasting \> one year OR non self-terminating AF lasting \> seven days but no more than one year with at least one failed DC cardioversion
* Have a concomitant indication for open chest and/or open heart surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, patent foramen ovale (PFO) closure or coronary artery bypass surgery
* Be able to take anticoagulation therapy
* Be able to fulfill study requirements
* Be able to sign study-specific informed consent

Exclusion Criteria:

* Presence of a previously implanted device in or adjacent to the treatment target area that may alter the delivery of therapy
* Prior cardiac surgery
* Presence of active endocarditis, local or system infection
* Presence of advanced heart failure (NYHA class \> II, \& LVEF \< 20%)
* Intraaortic balloon pump, IV inotropes or vasoactive agents within 30 days
* Emergent cardiac surgery due to acute MI or acute mitral regurgitation
* Life expectancy \< 1 year
* Major or progressive non-cardiac disease
* Presence of left atrial thrombi
* Left atrial diameter \> 6.0 cm
* Any condition that prevents investigator from safely performing procedure
* Positive urine or serum pregnancy test
* Prior left atrial ablation
* Currently participating in another clinical research study