cyrilzakka/clinical-trials huggingface dataset:
Ulinastatin's Anti-inflammatory Reaction in Cardiac Surgery

The purpose of the present study is to determine whether ulinastatin, urinary anti-trypsin inhibitor, attenuates cardiopulmonary bypass (CPB)-activated systemic inflammatory response in cardiac surgery with CPB.

Serial measurements and analysis of several inflammatory cytokines (bactericidal permeability increasing protein, interleukin-6, tumor necrosis factor-α)as well as markers of cardiac injury, renal impairment and oxygenation profile will be performed to determine ulinastatin's efficacy.

Applying aortic cross-clamp (ACC) and cardiopulmonary bypass (CPB) for cardiac surgery produces variable systemic inflammatory reactions. As a common complication of those reactions, pulmonary dysfunction, which usually indicated by postoperative hypoxemia, is frequently associated with cardiac surgery employing CPB and has been used as a major predictor of morbidity and mortality.

Circulating humoral and cellular factors are involved in the development of the systemic inflammatory reactions including organ dysfunction. So far, many studies analyzed the concentration of inflammatory marker (cytokine) to determine the degree of systemic inflammatory responses in various conditions.

Ulinastatin has anti-inflammatory activity and suppresses the infiltration of neutrophils. Previous studies suggested ulinastatin's cytoprotective effect against ischemia-reperfusion injury in major organs and its inhibition of inflammatory marker production.

The purpose of the present study is to determine ulinastatin's possible protective efficacy of in attenuating CPB-activated systemic inflammatory response regarding postoperative cardiac, renal and pulmonary dysfunction in cardiac surgery with CPB. Serial measurements and analysis of several inflammatory cytokines, such as bactericidal permeability increasing protein (BPI), interleukin (IL)-6, tumor necrosis factor (TNF)-α, as well as markers of cardiac injury, renal impairment and oxygenation profile, such as creatine kinase-MB (CK-MB), troponin I (TnI), C-reactive protein (CRP), arterial O2 tension /inspired O2 fraction (PaO2/FiO2 ratio), will be performed to this purpose.

Eligibility Criteria:
Inclusion Criteria:

* elective cardiac surgery employing CPB

Exclusion Criteria:

* urgent/emergency surgery,
* previous heart surgery,
* combined CABG and valve surgery,
* age \> 75 yrs,
* left ventricular ejection fraction \< 0.45,
* diabetes treated with insulin,
* active gastropathic disorder,
* treatment for chronic obstructive pulmonary disease,
* preoperative use of steroids
* postoperative re-operation due to bleeding control
* pre and postoperative renal replacement therapy
* left ventricular assist device implantation
Leptin and Visfatin in Diabetic Patients With Periodontitis Before and After Periodontal Therapy

1. Are adipokines involved in pathogenesis of periodontal disease in diabetic patients?
2. Does their level change after periodontal therapy?

Patients with chronic periodontitis only and patients with chronic periodontitis and diabetes were evaluated for levels of leptin and visfatin in the gingival tissues before and after non-surgical periodontal therapy.

Eligibility Criteria:
Inclusion Criteria:

* diabetic patients having diabetes mellitus ≥5 years prior to the study.
* chronic periodontitis with clinical attachment loss \> 5 mm.
* otherwise systemically healthy subjects.

Exclusion Criteria:

* any known systemic diseases other than diabetes.
* pregnancy or lactation.
* smokers.
* receiving periodontal treatment in the last 6 months.
* taking any drugs or medications other than anti-diabetic drugs.
Ivacaftor in French Patients With Cystic Fibrosis and a G551D Mutation

The purpose of this study is to determine whether the treatment with Ivacaftor remains effective and safe in the patients with cystic fibrosis (and at least one G551D CFTR mutation) in the real life setting, after the drug has been approved by the Health authorities.

The aims of our study are:

1. to describe the treated population at initiation of treatment,
2. to evaluate clinical parameters during the year before Ivacaftor was started, at initiation of treatment and during at least one year of treatment, until June 2014.
3. to evaluate the tolerance and safety of this treatment.

Eligibility Criteria:
Inclusion Criteria:

* French patients with CF aged 6 or older who are homozygous or heterozygous for the G551D mutation
* Treated with Ivacaftor
* First prescription of Ivacaftor before June 1st 2013 (including patients randomized in the VX770 clinical trials)

Exclusion Criteria:

* CF patients younger than 6 years old
* CF patients who have received lung transplantation
* CF patients without a G551D mutation.
Master Mind Program Evaluation Study

The purpose of this study is to conduct a randomized controlled trial to evaluate the efficacy of the Master Mind program, a mindfulness education substance abuse prevention program. The program has the goal of enhancing coping strategies and decision-making skills and preventing substance abuse in late elementary school students.


Eligibility Criteria:
Inclusion Criteria:

* English Fluency

Exclusion Criteria:

-
A Research Study Looking at the Safety of Multiple Doses of ZP8396 and How it Works in the Body of Healthy Participants

The trial is a single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial in normal weight and overweight but otherwise healthy subjects randomised to subcutaneous administration of ZP8396 or placebo

The research study will investigate the safety and tolerability of ZP8396 in healthy study participants. In addition, the study will investigate how ZP8396 works in the body (pharmacokinetics and pharmacodynamics).

The trial is divided in two parts:

Part 1: 20 Participants will receive 6 once-weekly doses as an injection under the skin (subcutaneous, s.c.). Participants will have 14 visits with the study team. 6 of these visits consists of overnight stays of different duration (2-4 nights) at the study site. For each participant, the study will last up to 116 days.

Part 2: 48 Participants will receive 16 once-weekly doses as an injection under the skin (subcutaneous, s.c.) in a dose up-titration dose scheme. Participants will have 23 or 24 visits with the study team. 13 of these visits consists of overnight stays of different duration (2-4 nights) at the study site. For each participant, the study will last up to 198 days.

Eligibility Criteria:
Inclusion Criteria:

Part 1:

* Body Mass Index (BMI) between 21.0 and 29.9 kg/m\^2, both inclusive
* Glycosylated hemoglobin (HbA1c) below 5.7 percent

Further inclusion criteria apply

Part 2:

* Body Mass Index (BMI) between 27.0 and 39.9 kg/m\^2, both inclusive
* Glycosylated hemoglobin (HbA1c) below 6.5 percent

Further inclusion criteria apply

Exclusion Criteria:

Part 1:

* History of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke
* Systolic blood pressure below 90 mmHg or above 139 mmHg and/or diastolic blood pressure below 50 mmHg or above 89 mmHg
* Symptoms of arterial hypotension

Further exclusion criteria apply

Part 2:

* History of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke
* Systolic blood pressure below 90 mmHg or above 159 mmHg and/or diastolic blood pressure below 50 mmHg or above 99 mmHg
* Symptoms of arterial hypotension

Further exclusion criteria apply
Characteristics of Patients Declining INKA Trial Participation

The objective of this study is to compare baseline characteristics of overweight knee OA patients accepting vs. declining enrolment in the INKA trial (NCT05172843) to explore if enrolled patients differ systematically from the declining participants with respect to both measured as well as unmeasured baseline characteristics.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or more
2. A clinical and radiological diagnosis of knee OA
3. BMI ≥ 30 kg/m2
4. Motivated for weight loss as by the provided program
5. Signed informed consent.

Exclusion Criteria:

1. The scheduled surgery is for revision of an existing prosthesis
2. Planned surgery for more than one knee within the observation period
3. KA indication due to sequelae of fracture(s)
4. Injection of medication or substances in the target knee within 3 months prior to participation
5. Immuno-inflammatory arthritis as cause of the knee OA
6. Current systemic treatment with glucocorticoids equivalent to \> 7.5 mg of prednisolone/day
7. Previous or planned obesity surgery
8. Inability to understand or read Danish incl. instructions and questionnaires
9. Any other condition or impairment that, in the opinion of the investigator (or his/her delegate), makes a potential participant unsuitable for participation or which obstruct participation.
Botox for Non-surgical Lateral Release in Patellofemoral Pain

The purpose of this study is to determine whether the use of botulinum toxin A injected into the lateral thigh muscle improves knee function and reduces knee pain secondary to patellofemoral syndrome. The study hypothesis is that botulinum toxin + specific exercises will be superior to specific exercises alone in improving knee function and reducing knee pain in individuals with patellofemoral syndrome.

Patellofemoral pain syndrome is a leading cause of knee pain in persons under 45 and is particularly common in women. The prevailing theory for the etiology of patellofemoral pain is an imbalance in force or timing of the pull of the knee extensor muscles on the patella resulting in improper tracking of the patella in the femoral grove. Specifically, the vastus medialis is thought to be ineffective in overcoming the lateral pull of the vastus lateralis. When exercises designed to focus on improving strength and timing of activation of the vastus medialis fail, surgical release of part of the attachment of the vastus lateralis to the patella is considered.

Botulinum toxin temporarily blocks acetylcholine release from motor neurons and is used clinically to produce muscle relaxation.

Subjects with patellofemoral syndrome will be recruited into the study. Half of the subjects will be given a placebo injection while the other half will be given an injection of Botox (Botulinum Toxin A, Allergen) into the vastus lateralis muscle. Group assignment will be randomized and a double blind protocol used. Prior to injection, the subject will record their level of knee pain, fill out several knee function questionnaires, and have the strength and endurance of their knee extensor muscles tested. All subjects will be given an exercise program designed to target strengthening of the medial thigh muscles as well as stretching of lateral structures.

At 4, 6 and 12 weeks knee pain and knee function will again be assessed.

Eligibility Criteria:
Inclusion Criteria:

* retropatellar knee pain
* pain with two of: prolonged sitting, climbing stairs, squatting, running, kneeling, hopping, jumping
* pain with patellar palpation
* symptoms minimum 1 month
* Visual Analog Scale for pain (VAS) usual pain 4 of 10 on VAS \[0-10 scale, anchors 0 = no pain, 10 = worst pain imaginable\]

Exclusion Criteria:

* history knee surgery
* history patellar dislocation
* clinical evidence of meniscal lesion, ligamentous instability, traction apophysitis around the patellofemoral complex, patellar tendon pathology, chondral damage, osteoarthrosis, spinal referred pain
To Study The Influence Of Genomic Factors On Metabolism And Effects Of Clomiphene In Asian Normogonadotrophic Anovulatory Patients.

The purpose of this study is to match the genetic component and clinical attributes of anovulatory patients with response to clomiphene treatment.

By improving our understanding on patient-specific clomiphene response will allow optimization of treatment, reduction of side-effects and shorten the time-to-pregnancy.

Anovulation is the commonest cause for infertility, with clomiphene being the standard treatment. Pharmacogenetic causes of variability in the pharmacokinetics and pharmacodynamics of clomiphene is not well characterized in anovulatory Asian women. Although recent findings suggest that the pharmacokinetics and pharmacodynamics of clomiphene may be influenced by several polygenic pathways involving genes regulating its metabolism (CYP3A4, CYP3A5, CYP2B6, CYP2C8, CYP2C19, CYP2D6), thus contributing significantly to the wide variability in dose-response relationships observed in clinical practice. There has not been objective evidence thus far from an unbiased genome-wide perspective. It is likely that polymorphisms at the CYP cluster of genes encoding for their respective cytochrome proteins may not explain all of the variability with regards to clomiphene's dose-response relationship.

The investigators hypothesize that the pharmacokinetics and pharmacodynamics of clomiphene is under strong control by genetic loci and that these genetic variants could also strongly determine the therapeutic outcome in Asian normogonadotrophic anovulatory patients. The contribution by candidate genes mentioned above will also be clarified in a definitive manner by this study.

Eligibility Criteria:
Inclusion Criteria:

* Women of reproductive age with ovulatory dysfunction desiring pregnancy,
* Willing to discontinue any form of herbal or traditional chinese medicines for at least three weeks before starting Clomiphene
* Ability to provide written and informed consent taken from participating patients, and
* Willingness to cooperate with study instructions

Exclusion Criteria:

* Pregnant at the time of recruitment,
* Ovarian cysts more than 5cm,
* Abnormal menorrhagia at the time of study recruitment,
* Abnormal liver function or active liver disease,
* Presence of neoplastic lesions of any type,
* Primary pituitary or ovarian failure (Type I and III World Health Organisation \[WHO\] Infertility)
* Patients with previous treatment with ovulation inducing agents such as follicle stimulating hormone (FSH) and luteinising hormone releasing hormone-analogues (LHRH-analogues);
* Infertility due to other endocrine abnormalities such as hyperprolactinaemia, hypo/hyperthyroidism, premature ovarian failure, diabetes or male factor
* Allergy to clomiphene.
* Fallopian tubal pathology (hydrosalpinges, previous salpingectomies)
* Patients on any drugs with potential to interact with CYP2D6 such as the selective serotonin receptor uptake inhibitors (ex. Venlafaxine, paroxitene, fluoxetine)
Study on Standard Evaluation System and Optimal Treatment Path of Senile Valvular Heart Disease

The key technology research and standard evaluation system of elderly heart valve disease evaluation is to further establish a domestic multi center and large sample full information big data platform of elderly heart valve disease based on the previous Chinese elderly valve disease cohort and clinical research platform and the national valve disease surgery data platform.

Establish clinical and Imaging Database

Eligibility Criteria:
Inclusion Criteria:

Patients with heart valve disease who are ≥ 65 years old and diagnosed by echocardiography meet the requirements

One of the following criteria:

* (1)Severe mitral stenosis: valve orifice area \< 1.0cm2;
* (2)Severe mitral regurgitation: constriction neck width ≥ 7mm, or regurgitation per beat (regurgitation volume)≥ 60ml, or reflux beam area / left atrial area \> 50%; Or effective reflux port area (eroa) ≥ 0.4cm2;
* (3)Severe aortic stenosis: mean cross valve pressure difference ≥ 40mmhg, or maximum jet velocity ≥ 4m / s, orValve orifice area \< 1.0cm2, it should be differentiated from left ventricular outflow tract stenosis;
* (4)Severe aortic regurgitation: constriction neck width \> 6mm, or each pulsation regurgitation ≥ 60ml, or regurgitation Flow fraction ≥ 50%, or jet width ≥ 65% of left ventricular outflow tract, or effective reflux orifice area (eroa) ≥0.3cm2；
* (5)Severe tricuspid stenosis: mean cross valve pressure difference ≥ 5mmhg;
* (6)Severe tricuspid regurgitation: constriction neck width ≥ 7mm, or effective regurgitation orifice area (eroa)≥0.4cm2；
* (7)Severe pulmonary stenosis: the forward blood flow velocity is ≥ 4m / s, which should be differentiated from right ventricular outflow tract stenosis; Severe pulmonary valve regurgitation: massive regurgitation, wide constriction neck

Exclusion Criteria:

* Patients unwilling to accept registration and follow-up;
* Patients with mental illness who cannot cooperate with information collection and follow-up
The Plasma Serotonin and Aortic Stenosis: a Pilot Study.

The goal of this study is to describe the increase in plasma serotonin or 5-hydroxytryptamine (5-HT) in patient with increased severity of aortic stenosis and increased weight cardiac muscle.

Calcific aortic stenosis is the most frequent valve disease in adults. Without therapeutic strategy, this disease leads to heart failure and death. Surgical aortic valve replacement is now a well tolerated cardiac surgery leading to excellent outcomes. Until recently, calcific aortic stenosis was considered to be histopathologically degenerative or passive in origin. It is now recognized, however, as a complex cellular process with features of atherosclerosis. It has been observed that drugs may slow dawn the progression of aortic stenosis in observational studies.

It has been suggested that serotonin, a monoamine neurotransmitter and a peripheral signal mediator, may be involved in the progression of aortic stenosis and also in its consequences on myocardium hypertrophy.

In the blood, serotonin in mainly stored in platelets, which release serotonin involved in post-injury vasoconstriction, thrombus formation, fibrosis and atherogenesis.

This study hypothesized those patients with aortic stenosis exhibit higher circulating serotonin levels than their counterparts without heart disease. In addition to circulating serotonin, its metabolite 5-HIAA will be systematically measured on all patients.

This study would allow to determine the potential of plasma serotonin as a prognosis marker and perhaps suggest the discovery of new targets for treatment of aortic stenosis.

Eligibility Criteria:
Inclusion Criteria:

* Group 1 : non aortic stenosis
* Goup 2, 3 and 4 : aortic stenosis

Exclusion Criteria:

-
The Cohort Study of Uveitis Patients

This study intends to explore the epidemiology, pathogenesis, clinical manifestations, diagnosis and treatment of uveitis. This is a cohort study. The outcome of the study is the activity of inflammation and visual prognosis. The purpose of this study is to determine the optimal diagnosis and treatment scheme for uveitis patients based on real-world data.


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis is uveitis; The agreement of enrolling this study;

Exclusion Criteria:

* Uveitis during the first month after any intraocular surgery; \<18 years; pregnant and lactating women; other conditions are unsuitable for participation in this study by the investigator such as mental abnormalities.
Cell Mediated Immunity in Older Adults

This study is to study the immune response to the flu vaccine in people 65 years old and older. Only adults 65 years old and older and who are getting their flu vaccine are being asked to join in this study. The investigators plan to enroll approximately 100 people in this study in the 2010-2011 flu season. Vanderbilt is working with the Centers for Disease Control and Prevention on this study.

There will be 5 study visits. Up to 4 tablespoons of blood from a vein will be obtained prior to the flu shot. Return visits will be 1, 2, and 4 weeks later,with up to 4 tablespoons of blood drawn again. Patients will be randomized to receive either the standard dose or the high dose flu vaccine. Both flu vaccines are FDA-approved.

During the 2010-2011 influenza season, approximately 100 adults ≥65 years of age will be enrolled. After consent, blood and serum will be collected and then subjects will be randomized to either standard or high dose influenza vaccine (both FDA approved vaccines). Vaccination will be done by an unblinded nurse. All further evaluations and analysis will be done by a blinded staff member. Medical history, relevant medications, and functional/nutritional status will be assessed at the first visit. Subjects will return (Table 3) for blood and serum draws on days 7, 14, 28 and for a serum blood draw after influenza season. No micronutrient samples will be drawn, but serum will be kept for possible vitamin D testing. During influenza season, subjects will answer a questionnaire about influenza-like illness (ILI) every two weeks (either by email or telephone) and will be asked to return for a nasal swab if an ILI is present. Comparisons will be made of the cell-mediated response of those vaccinated with standard versus high dose vaccines. Analyses will be done accounting for age, use of immunomodulating agents, and underlying medical conditions.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* aged 65+ years

Exclusion Criteria:

* \<65 years
* influenza vaccine allergy
* Guillain-Barre
* weight \<110 pounds
Dosing Obese With Noxafil® Under a Trial (DONUT)

Although posaconazole is approved for the prophylaxes and treatment of invasive fungal infections, specific dosing guidelines for posaconazole in (morbidly) obese patients are not specified. There is clear evidence indicating that heavier patients are receiving a sub-optimal dose if the current guidelines are used. Specifically in the setting of augmented prevalence of species with intermediate susceptible to posaconazole, adequate dosing is needed at start of treatment.

Therefore it seems prudent to conduct a trial in a cohort of obese patients who receive posaconazole (300mg or 400mg) and define the pharmacokinetics. These will then be compared to the pharmacokinetics in a normal-weight group receiving 300mg posaconazole.

Obese patients with a BMI ≥ 35 kg/m2 undergoing endoscopic gastric bypass surgery will receive a 300 mg or 400mg dose of posaconazole. A PK curve will be determined after administration at t=0.45, 0.75, 1, 1.5, 2, 4, 8, 12, 24, and (if feasible) 48 hours post infusion. Blood samples (4 mL) on PK days will be taken to obtain at least 2.0 mL of plasma.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects BMI:

   * obese groups: subject must have a BMI ≥35 kg/m2 at the time of inclusion,
   * non-obese group: subject must have a BMI ≥18.5 and \< 25kg/m2 at the time of inclusion.
2. Subject is at least 18 of age on the day of screening and not older than 65 years of age on the day of dosing;
3. If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant;
4. Subject is able and willing to sign the Informed Consent before screening evaluations.

   For the non-obese subjects the following additional inclusion criteria applies:
5. Subject is in good age-appropriate health condition as established by medical history, physical examination, electrocardiography, results of biochemistry, hematology and urinalysis testing within 6 weeks prior to study drug administration. Results of biochemistry, hematology and urinalysis testing should be within the laboratory's reference ranges (see Appendix A). If laboratory results are not within the reference ranges, the subject is included based on the investigator's judgment that the observed deviations are not clinically relevant. This should be clearly recorded;

Exclusion Criteria:

1. Documented history of sensitivity to medicinal products or excipients similar to those found in the posaconazole preparation;
2. History of, or known abuse of drugs, alcohol or solvents (up until a maximum of three months before study drug administration);
3. Use of medication that has known relevant interaction with study drug as determined by the investigator up to 1 weeks prior to study drug administration.
4. Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks prior to study drug administration;
5. Blood transfusion within 8 weeks prior to study drug administration;