cyrilzakka/clinical-trials huggingface dataset:
A Randomized Controlled Trial to Improve the Therapeutic Effect of Robot-assisted Radical Prostatectomy (RARP) Using Indocyanine Green Fluorescence Imaging

In Robotic Assistant Radical Prostatectomy (RARP), indocyanine green fluorescent solution is injected through the urethra, and the position and structure of the urethra are observed using the fluorescence imaging equipment that comes with the device. Guided by real-time fluorescence imaging, the urethra is precisely dissected and severed in front of the bladder neck. Through this improved operation, the bladder neck is protected, the neck injury that is common in conventional surgical operations is reduced, and the reconstructive surgical operations necessary after loss are reduced, and the surgical efficiency is improved. By protecting the bladder neck, the sphincter is better preserved, postoperative urinary incontinence is reduced, and the surgical outcome is improved


Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with prostate cancer who underwent robot-assisted radical prostatectomy at Shanghai First People's Hospital Patients with naïve localized prostate cancer or locally advanced prostate cancer The patient \> 18 years and \< 85 years Before the surgery, the prostate MR scan sagittal view of the prostate in our hospital measured the separation of the bladder neck \< 1cm The patient underwent robot-assisted laparoscopic radical resection of the prostate malignancy in our hospital with anterior approach The patient returned to normal after surgery, and there were no postoperative complications such as intestinal obstruction that affected the patient's blood routine and biochemical indicators

Exclusion Criteria:

Patients with metastatic prostate cancer Patients without preoperative puncture pathology Patients with sagittal bladder neck separation ≥ 1cm of prostate MR non-contrast prostate in our hospital before surgery Patients with preoperative examinations confirming that the enlarged prostate protrudes into the bladder floor Patients with preoperative examination confirming that the lesion is located at the tip of the prostate and near the bladder neck Patients with tumor stage reaching cT4 stage and possible invasion of bladder neck Patients who have undergone adjuvant therapy such as endocrine therapy and radiotherapy before surgery Patients with a history of any prostate surgery other than needle biopsy prior to radical resection of prostate malignancy Patients who have undergone resection of transurethral bladder lesions Patients who have undergone abdominal/pelvic surgery that makes it difficult to separate the prostate and surrounding structures during RARP Patients undergoing extended pelvic lymph node dissection during surgery Patients with posterior approach during surgery Patients with poor urinary continence due to any non-surgical factors after surgery Patients with a history of ICG allergy
Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease

The primary objectives of this study are to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.


Eligibility Criteria:
Key Inclusion Criteria:

* Chronic HCV infected, male and non-pregnant/non-lactating females aged 18 years or older who are on dialysis for ESRD, including adults with HIV co-infection if they are suppressed on a stable, protocol-approved antiretroviral (ARV) regimen for ≥8 weeks prior to screening.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Food Effect Study for PF-06372865

This study has been designed to investigate the effect of high fat food on the pharmacokinetics of PF-06372865 when administered to healthy subjects as single oral doses.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs);

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* Screening supine blood pressure \> 140 mm Hg (systolic) or \>90 mm Hg (diastolic), following at least 5 minutes of supine rest.
* Any condition possibly affecting drug absorption: current or recent (within one year) gastrointestinal disease; a history of malabsorption, esophageal reflux, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecysectomy) which would be expected to influence the absorption of drugs.
Biomarkers in Idiopathic Juvenile Arthritis

Juvenile idiopathic arthritis (JIA) is the most common form of arthritis in children. The etiology is unknown. Several types of arthritis fall under the JIA heading. Oligoarticular JIA with antinuclear antibodies affects about half of all children. There 's no specific markers. Our purpose is to identify new markers in this pathology. The ProtoArray®Human Protein Microarray allows rapid and efficient detection of protein interaction using a suitable protein or small molecule probe. The investigators hope so detect novel potential autoantigen biomarkers specific in JIA.

We select 10 patients with inclusion criteria and 10 controls. We analyse their blood sample (5ml). The ProtoArray® Microarray allows to detect novel protein-protein interactions, to rapidly perform serum profiling using a sensitive method to detect potential autoantigen biomarkers. The ProtoArray® Human Protein Microarray is a high-density protein microarray containing thousands of purified human proteins for protein interaction screening.

Eligibility Criteria:
Inclusion Criteria for experimental group :

* child age from 2 to 16 years
* Oligoarticular JIA with antinuclear antibodies
* with or without uveitis

Exclusion criteria for experimental group :

* immunosuppressive and biological therapy

Inclusion Criteria for control group :

* child age from 2 to 16 years
Lutein, Zeaxathin, and Fish Oil Supplementation

The goal of this clinical trial is to learn the impact of lutein, zeaxanthin, and fish oil (LZF) supplementation in healthy adults.

The main question it aims to answer is: Will supplementation with LZF improve macular pigment optical density (MPOD), cognitive performance and bone mass compared to controls after six months?

Subjects with an MPOD \<.43 will significantly improve MPOD after 6-months of LZF supplementation.

Consuming a LZFO supplement for 6-months will improve visual cognitive performance. Consuming a LZFO supplement for 6-months will improve bone density.

Participants will be asked to take either a LZF supplement or placebo daily for 6 months.

Macular degeneration, cognitive decline, and osteoporosis often occur with aging. Lutein, zeaxanthin, and fish oil (LZF) have been shown to have improvements in these areas. This 6-month double-blind randomized controlled trial will study the impact of LZF on cognitive performance, macular pigment optical density (MPOD), and bone health in healthy adults ages 18-45 with a MPOD \<.43. We seek to create a precision nutrition model reducing macular degeneration, cognition, and bone health that includes non-invasive screening for high-risk carotenoid deficiencies (MPOD, dietary intake) and individual response to LZF supplementation.

Healthy adults ages 18-45 years with MPOD \<.43 will be randomly assigned to take a LZF supplement with 7 mg lutein, 14 mg zeaxanthin, and 245 mg fish oil or a placebo daily for six months. They will have baseline and ending measures of fasting blood draw, MPOD, bone health using a DXA, and visual cognitive performance using Neurotracker software.

Eligibility Criteria:
Inclusion Criteria:

* \<.43 MPOD, a self-reported best-corrected vision of 20/40 or better in each eye, a BMI range of 18.5-30, and meets the inclusion criteria on the preliminary participant questionnaire.

Exclusion Criteria:

* allergic to lutein, zeaxanthin, or fish oil, taking supplements with \>6 mg lutein and/or \>2 mg zeaxanthin for more than two months before study starts, MPOD between \>.43, self-reported condition of vertigo, diabetic retinopathy, retinitis pigmentosa, optic neuropathy, retinal vascular occlusions, strabismus, autoimmune disorders related to visual health, currently pregnant or trying to become pregnant, history of concussion, vegan (due to gelatin in the placebo), and/or taking neuroactive medications, such as Ritalin, Adderall, antidepressants, etc.
Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) in Combination With Plerixafor for Autologous Stem Cell Mobilization in Patients With Multiple Myeloma or Non-Hodgkin Lymphoma

This study will compare the results of stem cell mobilization using drugs called filgrastim (Neupogen) and plerixafor with the results of stem cell mobilization using drugs called XM02 filgrastim (Granix) and plerixafor.

This study will compare the results of stem cell mobilization using drugs called filgrastim (Neupogen) and plerixafor with the results of stem cell mobilization using drugs called XM02 filgrastim (Granix) and plerixafor. The FDA has determined that Granix is biosimilar to Neupogen, which means that they are similar in terms of quality, safety, and efficacy; however, Granix has not been tested in the context of stem cell mobilization to see how its effectiveness compares to that of Neupogen

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Diagnosis of multiple myeloma or non-Hodgkin lymphoma
* Eligible for autologous transplantation
* Adequate bone marrow function as defined as:

  * White Blood Cell Count ≥ 3.0x109/L
  * Absolute Neutrophil Count ≥ 1.5x109/L
  * Platelet Count ≥ 100x109/L
* Able to understand and willing to sign an IRB-approved informed consent document
* Surgically or biologically sterile or willing to practice acceptable birth control, as follows:

  * Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of Day 1 of study treatment. Women of childbearing potential must agree to abstain from sexual activity or use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Acceptable methods of birth control include: barriers (condoms), oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives, and abstinence
  * Males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during and for 3 months after the treatment period. Acceptable methods of birth control include: barriers (condoms), oral contraceptive, intrauterine device (IUD), transdermal/implanted or injected contraceptives, and abstinence

Exclusion Criteria:

* Previous autologous stem cell collection
* Known hypersensitivity to filgrastim, plerixafor, or E. coli derived products
* Pregnant or breastfeeding
Lamelleye vs Comparator for the Treatment of Dry Eye Disease

Single-blind, randomised, single centre, 2-way crossover study to collect post-market clinical follow-up data on the CE-marked Lamelleye dry eye drops medical device.

The study is a 2-way crossover design comprising 2 treatments: the CE-marked Lamelleye dry eye drops, and a CE-marked comparator product. All Participants will be allocated to a treatment group in a random order.

This study design allows observations to be made between the treatments at both an intra- and inter-patient level regarding relationships between the patients' disease specific quality of life, symptoms and adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Participant has provided written informed consent.
2. Male or female Participants ≥ 18 and ≤ 79 years of age.
3. Participant has dry eye disease as diagnosed from positive responses to Non-invasive tear break-up time (NITBUT) (≤10 seconds); Schirmer test (≤10mm in 5 minutes); and patient symptoms (\>2 symptoms using the McMonnies Dry Eye Questionnaire)
4. Participant must understand and be able, willing and likely to fully comply with study procedures and restrictions.

Exclusion Criteria:

1. Active ocular infection
2. Ocular surgery within 6 months of study start date
3. Current contact lens wear
4. Any ophthalmologic drops within 1 week prior to enrolment that in the opinion of the CI or PI may interfere with the study outcomes.
5. Started or changed the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, anticholinergics, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of initial visit.
6. Systemic disease known to affect tear production or loss including, but not limited to thyroid eye disease, that has been diagnosed or has not been stable within 30 days of Visit 1.
7. Known hypersensitivity to any of the agents used in testing such as allergies to egg or soya based products.
8. Females who are or wish to become pregnant
Gefitinib (Iressa) in Combo With Chemoradiation in Patients With Locally Advanced Head & Neck Cancer

To determine the safety and tolerability of gefitinib in combination with cisplatin and radiation (3D-CRT or IMRT) in patients with locally advanced head and neck cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed head and neck cancer
* Lymph node negative or positive
* Metastasis negative
* Chemo- and radiotherapy naïve
* WHO 0-2
* Measurable disease by RECIST
* Written informed consent

Exclusion Criteria:

* Severe alcohol abuse
* Active ILD
* Co-existing chronic gastrointestinal disease(s)
* Brain metastasis
To Evaluate the Pharmacokinetics and Safety of AD-208

To evaluate pharmacokinetics and safety of AD-208.

The purpose is that pharmacokinetics and safety of AD-208 in healthy adult male volunteers are evaluated as compared to Avodart Soft Capsule 0.5mg.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male Adult aged between 19 to 50 at the time of screening visit
* Weight over 50kg and Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit
* No evidence of medical symptoms or signs of congenital or no chronic disease

Exclusion Criteria:

* If having a clinically significant disease or medical history for blood/tumor, genitourinary systen, liver/biliary system, kidney, respiratory system, alimentary system, endocrine system, immune system, cardiovascular system, nervous system, skin and psychical disorder, etc
A Comparative Study of Indobufen and Aspirin in Patients With Coronary Atherosclerosis

In addition, studies have found that indobufen can inhibit coagulation function in rats. Compared with aspirin, the duration of antiplatelet efficacy of indobufen was shorter, and the platelet function recovered completely 24 hours after drug withdrawal. However, there are few studies on the antiplatelet efficacy of indobufen. The investigators' previous study found that the inhibitory effect of indobufen 100 mg Bid on COX system in atherosclerosis or healthy volunteers was equivalent to that of aspirin 100 mg QD, but the inhibitory effect on platelet COX-1 channel was significantly weaker than that of aspirin 100 mg QD. In view of this, this study intends to investigate the antiplatelet effect of indobufen 200 mg Bid in patients with coronary atherosclerosis by comparing it with conventional-dose aspirin 100 mg QD.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of coronary atherosclerosis without indications for stent implantation.
2. Age ≥ 18 years, ≤ 65 years
3. Sign informed consent

Exclusion Criteria:

1. A history of asthma or allergic constitution or known allergy to indobufen or aspirin.
2. High risk of bleeding (low hemoglobin 10g / L, history of peptic ulcer disease, fecal occult blood positive or known active bleeding, history of cerebral hemorrhage within 6 months, history of fundus hemorrhage, etc).
3. Creatinine was 1.2 times higher than the upper limit of normal value and ALT was 1.2 times higher than the normal value.
4. History of smoking and alcoholism.
5. History of diabetes.
6. Pregnancy and lactation women.
7. Nonsteroidal anti-inflammatory or other antithrombotic drugs other than indobufen are required.
8. Any other reason may affect the results of this study.
Cardiovascular Outcomes and Mortality in Vascular Surgical Patients

This is a registry-based study of elective vascular surgical patients undergoing intermediate or high-risk vascular surgical interventions at Groote Schuur hospital, a tertiary academic center, over a 12 month period.


Eligibility Criteria:
Inclusion Criteria:

-

All patients undergoing vascular surgery:

1. 18 years and older
2. Elective procedures
3. Moderate- to high-risk surgical interventions

Exclusion Criteria:

1. Emergency vascular procedures
2. Low risk vascular surgery, i.e. venous stripping
3. All non-vascular surgical interventions
Effects of Statins on Pro- and Antioxidant Status : Link With Statin-Associated Myopathy.

To evaluate the effects of a 8-week treatment with 80 mg/day simvastatin on prooxidant and antioxidant status at rest and after exercise, on mitochondrial respiration and calcium release in skeletal muscle, and on aérobic aptitude in 24 healthy male subjects.

Day 1 : baseline oxidative status, lipid profile, exercice test, start of randomized treatment Day 53 : muscular biopsy Day 57 : follow-up oxidative status, lipid profile, exercice test, end of treatment

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.0 and 25.00

Exclusion Criteria:

-
Metformin for the Treatment of Hidradenitis Suppurativa (HS)

A randomized controlled trial investigating the metformin is the treatment for hidradenitis suppurativa. Metformin combined with doxycycline will be compared to the standard treatment of doxycycline monotherapy for HS severity and the effect on the pre-diabetic condition.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years at baseline
* A diagnosis of HS for at least 1 year prior to baseline
* mild to moderately active disease defined by a HS Physician Global Assessment (HS-PGA) score of 2-3 and the Refined Hurley classification of mild to moderate at baseline
* Indication for systemic therapy; i.e. uncontrolled disease under conventional topical therapy.
* Able and willing to give written informed consent and to comply with the study requirements

Exclusion Criteria:

* Pregnant and lactating women
* Concomitant diabetes mellitus
* Use of antibiotics within 14 days prior to baseline
* Use of immunosuppressing/modulating therapies within 28 days prior to baseline
* A known allergy to metformin or doxycycline or any of the ingredients metformin or doxycycline
Anti-CD25 rhMAb for aGVHD Prevention in High-Risk Adults Using the daGOAT Model

To assess the efficacy and safety of using recombinant humanized anti-CD25 monoclonal antibody injection as a prophylactic strategy for reducing the incidence of severe acute graft-versus-host disease (aGVHD) in adult patients at intermediate to high risk, as predicted by the dynamic aGVHD Onset Anticipation Tianjin (daGOAT) model, following allogeneic hematopoietic stem cell transplantation (allo-HSCT).


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 16 years, regardless of gender.
2. Patients with hematologic disorders who are scheduled to receive allo-HSCT.
3. Voluntarily join this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.

Exclusion Criteria:

1. Patients who have received a second or multiple transplants.
2. Patients who are allergic to, or intolerant of, a recombinant humanized anti-CD25 monoclonal antibody injection.
3. Pregnant or lactating female patients or female patients who are unable to take effective contraceptive measures during the entire trial period.
Bexsero™and Routine Infant Vaccines: Effect of Coadministration on the Safety of Immunization

Bexsero™ is a four component serogroup B meningococcal vaccine (4CMenB) licensed in Europe, Canada, and Australia in 2014. Prelicensure studies and post marketing surveillance data showed that 4CMenB has a high reactogenicity especially when coadministered with other infant routine vaccines \[1-2\]. While this suggests that coadministration causes an interaction resulting in a greater risk of adverse events following Immunization (AEFI) only the AEFI after the 4CMenB dose and not those occurring after routine vaccine immunizations were reported, underestimating the total risk associated with immunization at separate visits. For financial and practical reasons, coadministration of infant vaccines is preferred to separate visits. Separate visits may however be preferred if the sum of the AEFI risk at each visit is significantly smaller than the risk with coadministration and/or if the AEFI has a lesser severity. The purpose of this study is to recalculate the risk of occurrence and severity of AEFI with the coadministration of Bexsero™ and routine vaccines compared to separate injections to assess the interaction occurring with co-administration. Investigators will also estimate the risk of recurrence of AEFI at subsequent immunizations with the 4CMenB and assess if this risk varies with separate or coadministration with routine vaccines. To achieve these purposes, investigators will perform a secondary analysis of the data of three randomized controlled trials (clinicaltrials.gov identifiers: NCT00657709, NCT00847145 and NCT00721396) that evaluated 5025 children aged 2 to 14 months of whom 4535 were randomized to receive 3 to 4 doses of 4CMenB concomitantly or alternatively with routine vaccinations (DTaP-Inactivated polio virus -HepatitisB/Haemophilus influenzae type b \[Infanrix Hexa™\], Pneumococcal conjugate vaccine, 7 valent \[Prevenar™\] or Measles-Mumps-Rubella-Varicella vaccine \[Priorix-Tetra™\]) \[1,2\].


Eligibility Criteria:
Inclusion Criteria:

* Healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks
* Parent/legal guardian has given written informed consent after the nature of the study has been explained.

Main exclusion Criteria :

* History of any meningococcal B or C vaccine administration; prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens);
* Previous ascertained or suspected disease caused by N. meningitidis; History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
* Significant acute or chronic infection within the previous 7 days or axillary temperature major or equal to38 degrees within the previous day;
* Antibiotics within 6 days prior to enrollment;
* Any serious chronic or progressive disease;
* Known or suspected impairment or alteration of the immune system;
* Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.