cyrilzakka/clinical-trials huggingface dataset:
Ischemia and Reperfusion Injury in the Human: An Observational Study

We, the researchers at Lawson Health Research Institute, propose to investigate the impact of surgical ischemia and reperfusion on skeletal muscle microcirculation using a hand-held microscope.

We propose to investigate the impact of surgical ischemia and reperfusion on skeletal muscle microcirculation using a hand-held microscope.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing femoral distal bypass procedures for chronic limb ischemia

Exclusion Criteria:

* Any severe comorbid conditions (i.e., chronic obstructive pulmonary disease \[COPD\])
Music Therapy is Associated With Decreased Pain and Agitation in Intubated ICU Patients

The study is designed to analyze the use of music therapy to decrease pain and agitation in intubated ICU patients.

This is a randomized, prospective single-blinded placebo-controlled study of consecutive intubated ICU patients requiring anxiolytics and analgesic medications. Patients will be randomized into two groups: one group will receive music (MUSIC), whereas the other group (CONTROL) will wear headphones, but hear an audio loop of recorded ICU sounds (vent alarms, ambient noise, talking, etc). The two groups will then be analyzed for sedation and analgesia requirements; Ramsay sedation score, ICP in brain injured patients, ventilator days, ICU length of stay, hospital length of stay, mean arterial blood pressure (MAP).

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 70 years old, requiring intubation andmechanical ventilation, requiring sedation with propofol or benzodiazepines and/or analgesia with narcotics

Exclusion Criteria:

* hearing loss, psychiatric illness, hemodynamically unstable (requirement for vasopressor support)
Compare Effect of Surgical Antiseptic Preparations on Incise Drape Adhesion to Skin

The purpose of this study is to find out if presurgical antiseptic preparations affect how well surgical drapes adhere to skin.

Adhesive incise drapes are often used to provide a physical sterile barrier between the surrounding skin and the open wound at the beginning of a surgery. This study sought to determine the effect of presurgical skin antiseptic preparation on the adhesion of various incise drapes to the skin.

Eligibility Criteria:
Inclusion Criteria:

* Subject is willing to sign the Research Consent form
* Healthy male or female subjects ages between 18 - 65
* Subject has agreed to be and appears to be compliant with requirements of the study
* Subject has a back (the product application site) of sufficient size, free of blemishes to comfortably fit 18 strips of 1/2" x 3" drape samples
* Subject is willing to have the back clipped or shaved if it has excessive hair

Exclusion Criteria:

* Sensitivity/allergy to adhesive products (e.g. medical tapes)
* Sensitivity to the antimicrobial agent iodine, povidone iodine (PVPI), isopropyl alcohol (IPA), or chlorhexidine gluconate (CHG)
* Allergy to seafood
* History of psoriasis dermatitis, or any skin condition that might be exacerbated by the action of removing adhesive materials
* Active dermatitis (rash), sunburn, blemishes, broken skin, cuts, and/or infection on the subject's back
* History of diabetes
* Subject is currently pregnant or thinks she may be pregnant or is nursing
* Subject is receiving steroid-based anti-inflammatory or immunosuppressant drug therapy
* Subject is taking antihistamine medication
* Subject has been using moisturizers or other skin contact materials on the test sites for 24 hours prior to the start of the study
* Subject has a back problem that prohibits him or her from lying face downward for approximately 2 hours
SpyGlass AMEA Registry

The purpose of this study is to document indications for cholangioscopy and clinical utility of the SpyGlass Direct Visualization System (DVS) throughout the AMEA (Asia, Middle-East, Africa) region when used per standard of practice.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older.
* Willing and able to provide written informed consent to participate in the study.
* Willing and able to comply with the study procedures.
* Indicated for ERCP and cholangioscopy or indicated for ERCP with suspected need for cholangioscopy.

Exclusion Criteria:

* Endoscopic techniques are contraindicated.
* ERCP is contraindicated
* A medical condition that warrants the use of the device outside of the indication for use.
* Requirement for anticoagulation that cannot be safely stopped at least 7 days prior to the procedure.
The Effect of Pelvic Floor Exercise on Urinary Incontinence and Quality of Sex Life

This physiotherapist-guided group training programme should be performed in both the supine and the sitting positions; it is investigated, which is better and more cost-effective in patient motivation.

Here we aimed to investigate whether-based on trunk muscle synergism-the condition and functioning of the pelvic floor muscle would improve in the sitting and supine postures or in the control group during pelvic floor muscle training with forced exhalation. We enrolled nulliparous women in supine (n = 22), sitting (n = 19) and control (n = 14) groups. We performed the 8-week combined pelvic floor muscle training programme. We examined the effect of training on the parameters with the Kruskal-Wallis test, and the pairwise comparisons with the Mann-Whitney U-test and the Wilcoxon-rank test with the Bonferroni correction.

Eligibility Criteria:
Inclusion Criteria:

* We included in the study groups women participants willing to participate in the study and able to contract the pelvic floor and transversus abdominis muscles correctly. Participants were required to maintain their everyday activities (attending lessons, sport activities, and so on).

Exclusion Criteria:

* known neurological or rheumatological diseases and previous vaginal or abdominal surgery.
Epigenetic Safety of Assisted Reproductive Technology

The primary purpose of the study is to investigate the relationship between different protocols of assisted reproductive technology and the epigenetic safety of the offspring. Different interventions of assisted reproductive technology include controlled ovarian hyperstimulation (COH), in vitro embryo culture, in vitro fertilization(IVF), intracytoplasmic sperm injection(ICSI), frozen-thawed embryo transfer(FET), preimplantation genetic testing(PGT). The investigators are also interested in the relationship between pregnancy outcomes in ART or natural conception and environmental, nutritional and lifestyle factors.


Eligibility Criteria:
Inclusion Criteria:

1. Couples undergoing treatment for infertility or getting pregnant naturally and wanting to deliver their babies in Women's Hospital School of Medicine Zhejiang University, The International Peace Maternity \& Child Health Hospital, and Changhai Hospital of Shanghai.
2. Men 22-55 years old
3. Women 20 - 45 years old

Exclusion Criteria:

1. Any individual or couple who is outside of age range .
2. Any couple who don't plan to complete their pregnancy check-up or deliver their babies in Women's Hospital School of Medicine Zhejiang University, The International Peace Maternity \& Child Health Hospital, or Changhai Hospital of Shanghai.
Glutamine and Insulin Sensitivity in Type I Diabetes

Insulin is crucial to help the body metabolize ('burn') sugar (glucose). Even though juvenile (type 1) diabetes (T1D) is primarily due to the lack of insulin, patients with T1D tend to become less sensitive to insulin, particularly during adolescence.

The overall objective of this project is to gain further insight into the possible benefits of supplementation with glutamine (GLN), a natural dietary amino acid, enhancing insulin sensitivity in adolescents with T1D. To elucidate the impact of glutamine, the investigators will use a method called the 'euglycemic, hyperinsulinemic clamp': it consists of giving an IV drip of insulin, while the drop in blood sugar is prevented by giving variable, precisely measured amounts of glucose by vein: the amount of glucose required to prevent a drop in blood sugar reflects the body's sensitivity to insulin. The investigators will also give an IV drip of glucose and arginine (a building block of protein) 'tagged' with non-radioactive isotopes to better understand how glutamine may work. This procedure will be performed in 2 groups of 10 adolescents in the morning either after a strenuous exercise performed the previous afternoon (group 1; n=10), or after a sedentary day (group 2; n=10). Each subject will be studied twice, once after taking oral GLN, once after placebo, in separate clinical research center (CRC) admissions a few weeks apart, in random order.

Should the investigators hypothesis prove to be true, it would warrant long term studies to determine whether sustained dietary GLN supplementation can decrease insulin requirements and ultimately improve diabetes control in teenagers with T1DM, If successful, this approach could potentially have a significant positive impact in terms of adolescent health.


Eligibility Criteria:
Inclusion Criteria:

* Type I diabetes diagnosed for \> 12 months.
* Minimal weight of 40 kg
* Tanner stage IV or beyond
* All insulin programs, including intermediate/short acting insulins, Lantus/Detemir and short acting insulin or insulin pump therapy.
* HbA1C between 7.5 and 10%
* BMI between 10th to 85th percentile
* Patients on stable thyroid replacement therapy will be allowed to participate.

Exclusion Criteria:

* Celiac disease (any patient with history of positive serology or consuming a gluten-free diet)
* Cystic Fibrosis
* Chronic steroid therapy
* Chronic medications that may interfere with glucose metabolism or liver function
* History of mental retardation
* Presence of diabetic complications
* Positive pregnancy test
* Presence of significant anemia (Hb\<11 g/dL)
* Presence of intercurrent infection
Physical Activity for a Long and Healthy Life

The aim of the study is to 1) delineate the molecular mechanisms behind the large variation in insulin sensitivity among apparently healthy subjects and to 2) establish the dose-response relationship between physical training and a) metabolic health, b) appetite and c) cultural health.


Eligibility Criteria:
Inclusion Criteria:

* Healthy according to interview
* Caucasian
* Sedentary, Vo2max \< 45 ml/kg/min
* BMI 25-30 kg/m2
* Fat percentage 25% \<
* Weight stable (+/- 2 kg within past 6 months)

Exclusion Criteria:

* First degree relatives with type 2 diabetes
* Hemoglobin concentration \< 8 mmol/l
* Fasting plasma glucose 6.1 mmol/l \<
* Blood pressure 140/90 mmHg \<
* Regular intake of medicine
Molecular Background of Endothelial Cell Loss in Patients With Phakic Intraocular Lenses: a Tear and Aqueous Humour Analysis Study

Rationale: The number of highly myopic patients is increasing. Especially in East and Southeast Asia, up to 90% of adolescents are currently myopic. Long-term treatment of high myopia can be obtained by three types of surgery: laser refractive surgery, phakic intraocular lens (pIOL) implantation, and refractive lens exchange Implantation with a pIOL is the preferred treatment for high myopes, resulting in increasing patient numbers implanted due to the increasing numbers of patients with high myopia.

Long-term results show that implantation of a pIOL induces an accelerated decrease in corneal endothelial cells (EC). Although some risk factors for increase EC loss have been identified, the underlying mechanism is currently unknown. It is hypothesized that the aqueous flow in the anterior segment of the eye (i.e. anterior chamber) is disturbed, causing an altered nutritional flow in the anterior chamber. Another hypothesis is that the pIOL causes chronic subclinical inflammation in the anterior chamber resulting in increased EC loss. Currently there is insufficient proof to confirm or reject either hypothesis. If one of these hypotheses can be confirmed, it is likely to induces significant changes in clinical practice.

Objective: The primary objective of the study is to explore the role of inflammation in the anterior chamber on endothelial cell loss in patients implanted with iris-fixated pIOLs. The secondary objective is to identify whether there is a correlation between biomarkers in aqueous humour and biomarkers in tears, both related to the accelerated progression of EC loss.

Study design: Two strategies are incorporated in the design of this study. The first part will retrospectively evaluate EC loss in patients with iris-fixated (IF) phakic intraocular lenses (pIOLs). The second part is prospective and will compare EC measurements, cytokines in aqueous humour and in tears from patients scheduled for IF-pIOLs explantation and compare them to patients with routine cataract surgery.

Study population: Patients over 18 years of age, undergoing regular cataract surgery, and patients undergoing pIOL explantation in combination with cataract surgery. A total number of 126 patients is needed, equally divided over two groups.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Cataract in one or both eyes, or indication for pIOL explantation
* Informed and having given informed consent.

Exclusion Criteria:

* Insufficient understanding of the Dutch language to comply with study procedures
* Inability to complete follow-up or comply with study procedures
* Non-routine cataract surgery
* Cognitive or behavioral conditions that might interfere with surgery
* Patients with ocular comorbidities such as
* Women who are pregnant or nursing their child
* Immune-compromised patients (e.g., systemic corticosteroid use, leukaemia)
* Factors that increase the risk of complicated surgery
Effect of Liver and Blood-stage Treatment on Subsequent Plasmodium Reinfection and Morbidity

This study specifically seeks to quantify the contribution of relapes to the burden of P. vivax infections and disease by determining on the effect of radical pre-erythrocytic and erythrocytic clearance on subsequent rates of Plasmodium spp. infection and disease in children aged 5-10 years in a treatment to re-infection study design. In order the clear liver-stage/blood-stages G6PD-normal children were randomised to receive Chloroquine (3 days, standard dose) and Coartem (3 days, standard dose) plus either i) primaquine (20 days, 0.5mg/kg) or ii) placebo (20days). These drugs were administered over a period of 4 weeks.

In addition to this epidemiological data, the study will assess the natural acquisition of cellular and humoral immune responses to P. falciparum and P. vivax, thus assisting in the determination of correlates of clinical immunity to P. falciparum and P. vivax in PNG children aged 5-10 years.

These data will not only be essential for development of future vaccines against P. vivax and P falciparum but provide invaluable insight into the contribution of long-lasting liver-stages to the force of infection with P. vivax that will contribute towards designing more rational approaches to the treatment of P. vivax both in the context of case management and future attempts at elimination.


Eligibility Criteria:
Inclusion Criteria:

* aged 5-10 years (±3 months)
* permanent residents of the area
* absence of history of hypersensitivity reactions to the drugs

Exclusion Criteria:

* chronic illness
* severe malnutrition (weight-for-age nutritional Z score \[WAZ\] \<60th percentile)
* severe anemia (Hb \<5 g/dL),
* G-6-PD deficiency (\<60% G-6-PD activity)
* permanent disability, which prevents or impedes study participation. Any 1 or more of the criteria is sufficient to exclude study participation.
Determination of the Levels of Lipocalin-2 and Semaphorin3A

The aim of this clinical trial is to investigate the concentrations of Lipocalin-2 and Semaphorin 3A levels in gingival crevicular fluid in subjects with different periodontal diseases. At the same time for the periodontitis group; the purpose of this study is to analyze the correlation of these proteins with clinical parameters at the first and third months after the nonsurgical periodontal treatment.

In our study, gingival crevicular fluid samples will be taken along with the measurement of all oral clinical parameters from sixty systemically healthy volunteers (20 periodontally healthy, 20 gingivitis, and 20 periodontitis). Gingival crevicular fluid samples will be taken again after the nonsurgical periodontal treatment for the periodontitis group in the first and third months. Lipocalin-2 and Semaphorin 3A levels will be determined by an enzyme-linked immunosorbent assay test (ELISA). Subsequent statistical analyses will be used to interpret protein levels among different groups and peridontitis group after the nonsurgical periodontal treatment.

Possible significant differences may illuminate the future work with Lipocalin-2 and Semaphorin 3A. Also, these glycoproteins may help to develop different diagnostic methods or treatment strategies for future periodontal treatments.

Eligibility Criteria:
Inclusion Criteria:

* Being systemically healthy
* Having at least 20 teeth in the dentition, excluding third molars
* Not using alcohol nor smoking
* Not using medications
* Not taking any antibiotics, anti-inflammatory, nor systemic corticosteroid drugs in the last six months
* Not being in the lactation period nor pregnancy

Exclusion Criteria:

* Having any oral or systemic diseases
* Using alcohol or smoking
* Using medications
* Taking any antibiotics, anti-inflammatory, or systemic corticosteroid drugs in the last six months
* Being in the lactation period or pregnancy
* Being treated with periodontal treatment in the last six months
Tau Imaging in Professional Fighters

Subjects enrolled in the Professional Fighters Brain Health Study (PFBHS) will receive flortaucipir to explore its use as a biomarker for brain injury related to repetitive head trauma and to examine the relationship between clinical presentation and tau deposition.


Eligibility Criteria:
Inclusion Criteria:

All Subjects

* Currently enrolled in the PFBHS protocol and have participated in a minimum of 10 professional fights
* Can tolerate Positron Emission Tomography (PET) scan procedures
* Have the ability to provide informed consent

Subjects with cognitive impairment

* Have subjective cognitive complaints or objective decline or impairment as determined by the investigator

Exclusion Criteria:

* Have behavior dysfunction that is likely to interfere with imaging
* Are claustrophobic or otherwise unable to tolerate the imaging procedure
* Have current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram
* A history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs that are known to cause QT-prolongation
* Have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
* Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
* Have current drug or alcohol dependence or alcohol dependence within the past 2 years
Evaluation of the Effectiveness of an Amnion-chorion Membrane for Alveolar Ridge Preservation

This study will examine whether adding an amnion-chorion membrane on top of the traditionally used collagen plug will lead to more bone formation compared to the collagen plug only.

Bone grafts and membranes are commonly placed to increase the amount of bone right after tooth extraction and before placing a dental implant. The primary objective of this study is to study the effect of a human amnion-chorion membrane (ACM) in an exposed-barrier ridge preservation technique to a control group without utilizing a ACM.

30 patients requiring a front tooth extraction will be recruited and randomized to receive bone grafting with or without an ACM.

Eligibility Criteria:
Inclusion Criteria:

1. Age range: 20 to 80 years.
2. Patients must require tooth extraction (for incisors, canines and premolars) as a result of caries, periodontal disease, tooth fracture or deemed unrestorable.
3. Socket should be free of infection, less than 5mm of dehiscence
4. Patients interested in implant placement following tooth extraction.

Exclusion Criteria:

1. Allergies or hypersensitivities to study related medications such as chlorhexidine.
2. Hematologic disorders/blood dyscrasias.
3. Active infectious diseases of any kind.
4. Liver or kidney dysfunction/failure.
5. Uncontrolled diabetes (HbA1c \> 8).
6. Active cancer treatment - such as active chemotherapy or radiation therapy.
7. Taking medications that will affect their bone healing (for example, bisphosphonates).
8. Metabolic bone diseases that affect bone healing such as osteoporosis.
9. Pregnant or lactating women (self-reported).
10. Smoke 10 or more cigarettes per day (self-reported).
11. Poor oral hygiene.
Does Vaginal Washing Affect the Success Rate of the Labour Induction?

Investigators will use dinoprostone(Propess TM) for cervix ripening and labor induction in term pregnant women.Vaginal pH base is achieved with the effect of hormones in pregnancy and associated with this, vaginal infections rates increase. With the vaginal application of Propess, the preparate remains in the vagina for a long time, with controlled release,creating a film layer against bacteria and especially fungal infections and it was thought that this could be a reason for unsuccessful birth induction by preventing release of this ovule.

The aim of this study is to observe whether or not the rate of caesareans with the indication of unsuccessful induction was reduced in patients by reducing the density of vaginal bacteria and fungi with vaginal lavage and thereby increasing the effect of the drug and decreasing the rate of unsuccessful inductions.

The study will include patients meeting the study criteria monitored in the delivery .

Verbal and written informed consent will be obtained from all patients before starting the study. The patients will be randomised to 2 groups. In one group, vaginal lavage (the vagina will first be washed with saline in a 20cc injector) will be applied then Propess will be used and in the other group Propess will be used without any lavage.

It is planned to include 70 patients in each group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with singleton pregnancies
* Term gestational week (defined as\>37 weeks),
* Fetal cephalic presentation
* Participiants with with intact amniotic membrane
* Reactive fetal heart rate
* Cervical Modified Bishop's score \<5

Exclusion Criteria:

* Patients with with multipl pregnancies
* Participiants with malpresentation anomalies
* Participiants with nonreassurring fetal heart rate
* Participiants with more than three contractions in 10 minutes
* Participiants with contrandications for using prostaglandins
* Participiants with fetal anomaly
* Participiants with fetal demise
* Participiants with emercency delivery indications,
* Participiants with previous cesarean delivery or have other uterine surgery
* Participiants with cephalopelvic disproportion