cyrilzakka/clinical-trials huggingface dataset:
Pharmacodynamic Drug Interaction Between Cilostazol and Statins

The purpose of this study is to evaluate pharmacodynamic drug interaction between cilostazol and statins (simvastatin as a CYP3A substrate and rosuvastatin as a non-CYP3A substrate) in healthy male subjects.

Subjects suitable for this study will visit to the Clinical Trial Center, Samsung Medical Center for 7 days and pharmacodynamic samplings will be performed following the administration of study drugs.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 20 - 55 years
* A body mass index in the range 18.5 - 27 kg/m2
* Willingness to participate during the entire study period
* Written informed consent after being fully informed about the study procedures

Exclusion Criteria:

* Any past medical history of hepatic, renal, neurologic, cardiovascular, respiratory, endocrine, hemato-oncologic or psychiatric disease
* Active bleeding or bleeding tendency
* History of gastrointestinal disease or surgery possibly affecting drug absorption
* History of clinically significant drug hypersensitivity
* Use of medication within 7 days before the first dose
* Heavy drinker (\>140 g/week)
* Whole blood donation during 60 days before the study
* Judged not eligible for study participation by investigator
Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices

The registry is primarily designed to assess outcome, efficacy and residual safety aspects of CRT based on long-term data from an unselected, real-life clinical set-up. Moreover, the observation of the patient status should help to find possible predictors for HF events and to identify areas of improvement for CRT and for CRT device settings.


Eligibility Criteria:
Inclusion Criteria:

* Planned de novo implantation of or upgrade to a CRT system for treatment according to the intended use
* Patient is able to understand the nature of the registry and has provided written informed consent
* Patient is willing and able to use the CardioMessenger and accepts the Home Monitoring concept
* Remote monitoring using the Home Monitoring® platform is planned for the patient

Exclusion Criteria:

* Standard contraindication for CRT
* Already or previously implanted with CRT system
* • Age \< 18 years
* Participation in another interventional clinical investigation other than the registry-based trials of BIO\|STREAM.HF
* Pregnant or breastfeeding
Role of Antioxidants in Unexplained Oligohydramnios,A Randomized Trial

To predict the effect of antioxidants in cases of oligohydramnios

Type of study:

This is a prospective randomized controlled study that was done in department of obstetrics and gynecology of Assiut University Hospital.

Aim of the work:

1. To study the effect of antioxidants in cases of oligohydramnios.
2. To study the effect of antioxidants on mode of delivery and neonatal outcome.
3. To commence special recommendations from the study about the use of antioxidants in cases of oligohydramnios of unknown cause and cases of oligohydramnios associated with pregnancy induced hypertension.

Inclusion criteria:

Patients with gestational age between 30-34 weeks with:

* Oligohydramnios of unknown cause.
* Oligohydramnios assosiatd with Pregnancy induced hypertension (PIH).

Exclusion criteria:

1. Premature rupture of membranes.
2. Oligohydramnios in postdates pregnancy (\>41 weeks).
3. Fetal anomalies.
4. IUGR.
5. Patients using non steroidal anti-inflammatory drugs.

Assessment of the patients:

The target population was assessed to find the participating women suitable for the study, this assessment was done to verify inclusion criteria and to exclude any women has any of the exclusion criteria.

Ultrasongraphic evaluation:

Ultrasongraphy was done for estimation of amniotic fluid index by measuring the vertical diameter of the pockets of amniotic fluid in four sections of the uterus and add them together. This gives them a number known as amniotic fluid index (AFI). If the AFI is less than 5 centimeters, the pregnant woman has oligohydramnios

Composition of omega-3 plus:

Soft gelatineous capsule (Sedico medical company) each capsule contains:

* Fish oil (30) % (Eicosapentaenoic acid (EPA) 18 % / Docosahexaenoic acid (DHA) 12 % ) natural source of Omega 3 Fatty acids.
* Wheat germ oil (Tocopherol: N.N.T. 0.22 %) which is rich and natural source of Vitamin E (protects the oils from oxidation. besides its well known that requirements of vitamin E increases with increased dietary amounts of polyunsaturated fatty acids).

Eligibility Criteria:
Inclusion Criteria:

* Patients with gestational age between 30-34 weeks with:
* Oligohydramnios of unknown cause.

Exclusion Criteria:

* 1- Premature rupture of membranes. 2- Oligohydramnios in postdates pregnancy (\>41 weeks). 3- Fetal anomalies. 4- IUGR. 5- Patients using non steroidal anti-inflammatory drugs. 6 - Oligohydramnios assosiatd with Pregnancy induced hypertension (PIH).
Exercise Prior to Allogeneic Hematologic Stem Cell Transplantation

The investigators hypothesize that inactivity during the search for a donor may exacerbate current deconditioned states; subsequently, influencing risk factors for post-transplant complications that hinder the recovery phase.

This study is designed to investigate if exercise therapy administered prior to allogeneic hematologic stem cell transplantation (HSCT) can influence physical and psychological side-effects associated with HSCT. Approximately 6-weeks prior to HSCT, individuals will be randomized into either an exercise group or usual care group and followed until one year after HSCT.


Eligibility Criteria:
Inclusion Criteria:

* Medical indication: allogeneic stem cell transplantation at Princess Margaret Hospital
* must be ambulatory without need for human assistance at time of recruitment
* medically cleared to exercise by the transplant physician
* demonstrates willingness to attend supervised sessions
* sufficient in English to ensure safety of understanding prescribed exercise guidelines, or has access to an adequate non-familial interpreter

Exclusion Criteria:

* another active malignancy
* less than 4 weeks till the scheduled HSCT
* refusal to be randomized
* does not have the approval of their transplant physician
* severe or unstable neurological, cardiorespiratory, musculoskeletal disease or mental illness
Evaluate the Efficacy and Safety to Tenofovir Disoproxil in Chronic Hepatitis B Patients

This study evaluates the efficacy and safety of switching to Tenofovir Disoproxil from Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients who pretreated with Tenofovir Disoproxil Fumarate.

In Open-Label, phase 3 studies, we randomly assigned patients with hepatitis B e antigen (HBeAg)-negative or HBeAg-positive chronic HBV infection to receive Tenofovir Disoproxil or Tenofovir Disoproxil Fumarate (ratio, 2:1) once daily for 48 weeks

Tenofovir Disoproxil and Tenofovir Disoproxil Fumarate is a nucleotide analogue and a potent inhibitor of human immunodeficiency virus type 1 reverse transcriptase and hepatitis B virus (HBV) polymerase.

The primary efficacy end point at week 48 of this study was defined as the combination of an HBV DNA level of less than 400 copies per milliliter and histologic improvement .

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for at least 6 months.
* HBeAg negative and HBeAb positive at screening

Exclusion Criteria:

* Pregnant women, women who are breast feeding, or women who believe they may wish to become pregnant during the course of the study
* Males and females of reproductive potential who are unwilling to use an effective method of contraception during the study.
* Decompensated liver disease defined as conjugated bilirubin \> 1.5 x ULN, prothrombin time (PT) \> 1.5 x ULN, platelets \< 75,000/mL, serum albumin \< 3.0 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)
* Significant renal, cardiovascular, pulmonary, or neurological disease
* currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion
Facial Hair Reduction Using Intense Pulsed Light (IPL) & Alexandrite Laser

The purpose of this study is to compare the efficacy of the IPL system 650advance handpiece with the alexandrite laser for the purposes of female facial hair reduction

This is a randomised (splitface)controlled trial, comparing the use of the Intense Pulsed Light (IPL) system 650 advance handpiece against the Alexandrite Laser for the purposes of female facial hair reduction. Previous studies have shown that the alexandrite laser is superior to IPL in achieving hair reduction. A new handpiece (Lynton, Lumina 650 advance) available for the IPL system is designed to further optimise its use in removing female facial hair (particularly those hair colours previously unresponsive to treatment). This study will compare the alexandrite laser to the IPL system using the new handpiece. This may lead to improvements in the treatment of female patients with male pattern facial hair. Female patients referred to our facial hair reduction service will be recruited to this study. 1/2 their face will be treated with IPL and 1/2 with alexandrite laser. Each participant will receive 6 full treatments at approximately 6 weekly intervals. Participants will be asked to fill in a satisfaction questionnaire and have clinical photographs taken pre treatment and at 1 and 3months post final treatment. All treatments will be carried out in our dedicated laser suite at Glasgow Royal Infirmary.

Eligibility Criteria:
Inclusion Criteria:

* Female Patients
* Minimum age 16years old
* Fitzpatrick skin types I-III
* Significant facial hair.

Exclusion Criteria:

* Fitzpatrick skin types IV-VI
* Age less than 16years old
* Males
* No visible facial hair growth
* Use of electrolysis or depilatory creams 6weeks prior to treatment
* Active acnes
* Current coldsore
* Previous facial hair removal with laser or IPL in past 12 months
* Sun tanned skin
Quantitative ICG Fluorescence Angiography in Colorectal Surgery

Fluorescence angiography with indocyanine green (ICG-FA) has gained increased popularity in colorectal surgery to check perfusion to the newly-formed anastomotic area and decrease the rate of postoperative anastomotic leakage.

While qualitative ICG assessment has the advantage to be used instantly during the operative procedure, it does bear drawbacks (subjective assessment, dependent on factors like camera distance, ICG dose and white-light contamination).

The alternative is quantitative ICG assessment, which is performed by evaluating the time-intensity curve of the ICG-FA with an external analyzing software. The procedure is showing promising results, but the methodology is still reported very heterogeneously.

This study is a multi-center, prospective, standardized, surgeon-blinded observational trial. The key aspect of this study is the non-interventional design with blinding of both the qualitative and quantitative results from the ICG perfusion measurement, providing no chance of influencing the course of the operation. Assessment of perfusion will be performed postoperatively blinded to the outcome. Assessment of the pre-anastomotic area is intraoperatively performed by an image analysis software that then calculates a perfusion score based on an algorithm integrating relevant perfusion metrics. The primary outcome is the combined rate of early and late anastomotic complications within 90 days postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Capable of giving informed consent
* ASA Classification: status I-III
* Planned for PME or TME with minimally invasive approach and primary anastomosis
* Strong suspicion of or biopsy-verified sigmoid or rectal cancer Stage I-IV cancer

Exclusion Criteria:

* Known allergy to ICG or iodine
* Emergency procedure
* Pregnancy or if the patient is currently nursing
* Surgeons decide to do unblinded quantitative or qualitative ICG-FA
The Anti-snoring Bed

Habitual snoring is a widespread complication. Most snorers snore predominately when sleeping in supine position. Therefore, therapeutic interventions force snorers to avoid supine position. Devices that restrict the sleeping position or raise alarms when the user obtains the supine position cause discomfort or disrupt sleep resulting in low compliance. Therefore, anti-snoring mechanisms, which lift the trunk of the user without disturbing sleep, have been proposed.

We set out to investigate whether individual interventions provided by beds with lifting mechanisms are able to stop snoring within three minutes (success rate) and whether the bed reduces the snoring index (number of total snores divided by total time in bed). In addition, we investigat whether the trunk elevation provided by the bed is interfering with the subjective sleep quality assessed using the Groningen Sleep Quality Score.

Subjects are observed for four nights (adaptation, baseline, and two intervention nights). During intervention nights, the bed lifts the trunk of the user in closed-loop manner. Subjects are divided in three groups (non-snorers, snorer group one, and snorer group two). Non-snorers are lifted by the bed at random time points during the night. In snorer group one, a stepwise increase of the bed inclination is compared with going directly to a randomly selected angle. In snorer group two, the influence of a small inclination angle (10°) and a big inclination angle (20°) is compared..


Eligibility Criteria:
Inclusion Criteria:

* none

Exclusion Criteria:

* Pregnancy
* Previously diagnosed sleep-related breathing disorders
* Chronic lower back pain
* Heart insufficiency that might impede sleeping in supine position
* Inability to follow the procedures of the study, e.g. due to language problems
Effect of an Educational and Explanatory Program for a Surgical Act on Preoperative Anxiety

The main objective of this study is to evaluate the impact on preoperative anxiety of an education and information program conducted prior to non-urgent coronary angiography performed in patients hospitalized at the Nîmes University Hospital.

The secondary objectives of this study are to assess the impact of the HEARTLINK program on the following parameters:

A. Duration of hospital stay; B. Per operative blood and heart rate?; C. Patient satisfaction (visual analog scale).

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Patient for whom elective coronary angiography is indicated
* The patient has never had a coronary angiography before

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant or breastfeeding
* The subject has already had a coronary angiography
* The subject has a cognitive impairment
Diurnal Variation of Tear Meniscus and Tear Osmolarity

This study is to determine the diurnal variation of tear meniscus and tear osmolarity in normal subjects and dry eye patients.

This study is to determine the diurnal variation of tear meniscus using OCT and tear osmolarity using Tearlab's osmolarity system in normal subjects and dry eye patients.

Eligibility Criteria:
Inclusion criteria

1. Is at least 18 years old and has full legal capacity to volunteer;
2. Has read and signed the IRB Informed Consent Document;
3. Is willing and able to follow participant instructions;
4. Has clear corneas;
5. Has 20/100 uncorrected visual acuity or better;
6. Is not a hard (or rigid gas permeable) contact lens wearer within the last year;
7. Was a soft contact lens wearer, but stopped wearing at least 1 week ago;
8. Has dry eye according to the study definition of DES (study subjects).

Exclusion criteria

1. Has any systemic disease affecting ocular health except for Sjögren's syndrome;
2. Is using any systemic or topical medications that will affect ocular health except for artificial tears;
3. Has an active ocular disease other than DES, meibomian gland disease or Sjögren's syndrome
4. Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
5. Has limbal or bulbar injection or corneal staining that was clinically significant, which are not due to DES;
6. Has worn rigid gas permeable lenses within 1 year;
7. Has had surgery or an eye injury within 6 months.
A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design

The objective of this study is to evaluate the safety and efficacy of a new silicone hydrogel contact lens compared to the Bausch + Lomb PureVision contact lens when worn by adapted soft contact lens wearers.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have clear central corneas and be free of any anterior segment disorders.
* Subjects must be myopic, and wear contact lenses in each eye.
* Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily wear basis for approximately 3 months.

Exclusion Criteria:

* Subjects who are older than age 40 on the date the informed consent (ICF) is signed.
* Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with an active ocular disease or who are using any ocular medication.
* Subjects with any grade 2 or greater finding during the slit lamp examination.
* Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Subjects who are allergic to any component in the study care products.
Anesthesia Standard Operating Procedure During On-pump Coronary Artery Bypass Grafting

Background: Despite improvements in surgical and anesthesia procedures over the past 15 years complications during cardiac surgery still remain high. Bridgewater B et al. describes mortality during on-pump coronary artery bypass grafting (CABG) at 2%-3%, and the rate postoperative complications about 20%-30%. At the same time, the standard of care in patients undergoingon-pump CABG is not fully established.

Hypothesis, Research Need: Use of multimodal low-dose opioid anesthesia during CABG decreases inflammatory response and the incidence of early postoperative cardiac complications due to a reduction in interleukin-6.

Methodology: According to anesthesia standard protocol, all patients were divided into two groups - study group with multimodal low-dose opioid anesthesia (60 patients) and control group with a high-dose opioid anesthesia (60 patients). Primary (IL-6 at the end of the operation) and secondary clinical outcomes (postoperative atrial fibrillation (POAF), low cardiac output syndrome (LCOS), duration of mechanical ventilation (MV), length of intensive care unit (ICU) stay, length of hospital stay) were compared between the groups.

Analysis Tools: Clinical observations; instrumental research methods (electrocapdiography, echocardiography); labs (blood gases, hemoglobin, electrolytes); enzyme-linked immunosorbent assay (IL-6); statistical (Student's t-test, Mann-Whitney U test, χ2-test, correlation analysis).

Expected Outcomes: Use of multimodal low-dose opioid anesthesia during CABG will decrease inflammatory response (lower levels of IL-6 at the end of the surgery) and the incidence of early postoperative cardiac complications, expressed as lower incidence of LCOS and POAF, lower duration of MV and lower length of ICU stay.


Eligibility Criteria:
Inclusion Criteria:

* age from 44 to 65 years,
* nn ejection fraction \> 30%,
* operational risk assessment for EuroSCORE II \<5%,
* on-pump coronary artery bypass grafting

Exclusion Criteria:

* patient's refusal
* off-pump coronary artery bypass grafting
* the need for additional intervention on the heart
Thalamus Seizure Detection With a Deep Brain Stimulator System

The purpose of this study is to determine the feasibility of chronic ambulatory thalamus seizure detection. The sensitivity, specificity, and false alarm rate of thalamus seizure detection will be calculated using recordings from a deep brain stimulation system, assessed relative to concurrent gold-standard video-EEG monitoring collected in the in-patient setting (epilepsy monitoring unit), in 5 patients with drug resistant epilepsy.


Eligibility Criteria:
Inclusion Criteria:

Participants must meet all of the inclusion criteria to participate in this study:

* 18 years of age and older.
* Implanted with a clinical DBS system for epilepsy with brain recording capabilities (Medtronic Percept™ DBS).
* Subject or legally authorized representative is able to understand study procedures and to comply with them for the entire length of the study.

Exclusion Criteria:

All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation:

* Health status or any clinical conditions (e.g., life expectancy, co-existing disease) that, in the opinion of the site investigator, would pose undue risk to undergo epilepsy monitoring unit evaluation for the purpose of seizure characterization.
* Women will verify not pregnant, and if applicable, have urine pregnancy test.
* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent.