cyrilzakka/clinical-trials huggingface dataset:
Determining the Tolerance of Depigmented Skin to Targeted Phototherapy Using UVB in Patients With Vitiligo

The purpose of this study is to determine if vitiligo patients develop tolerance to ultraviolet light therapy, a type of treatment available for vitiligo.

Patients with vitiligo received 6-9 ultraviolet B treatments, 2 to 3 times weekly. Minimal erythema dose (MED) testing was done at baseline and after all treatments; the percent change in MED was analysed as a measure of photoadaptation. The percent decrease in cyclobutane pyrimidine dimers (CPDs) over 24 hours after a single exposure of 1 MED was analysed on vitiliginous and normal skin.

Eligibility Criteria:
Inclusion Criteria:

For inclusion, the subject must:

1. Be at least 18 years old
2. Be otherwise healthy
3. Have a diagnosis of vitiligo affecting \> 5% body surface area (BSA)
4. Have two depigmented lesions on opposite sides of the body that can be biopsied at the end of TARGETED UVB PHOTOTHERAPY treatment
5. Agree to abide by the Investigator's guidelines regarding photosensitizing drugs
6. Have a negative pregnancy test at baseline if female of childbearing potential
7. Be able to understand the requirements of the study, the risks involved, and is able to sign the informed consent form
8. Agree to follow and undergo all study-related procedures

Exclusion Criteria:

Subjects will be excluded if any of the following apply:

1. Women who are lactating, pregnant, or planning to become pregnant
2. Patients with a recent history of serious systemic disease
3. Patients with a known history of photosensitivity
4. Concomitant use of systemic or topical treatments for vitiligo. Patients must discontinue PUVA or oral corticosteroid therapy for 4 weeks prior to the start of any treatment. If a patient is taking any vitamins or dietary supplements, the patient must discontinue them for the duration of the study. Topical therapy such as corticosteroids, topical immunomodulators (e.g., Protopic or Elidel), vitamin D derivatives (e.g., Dovonex), or UVB phototherapy must be discontinued for 2 weeks prior to the start of study treatment.
5. Patients diagnosed to be immunosuppressed for any reason (e.g., HIV infection, lupus, cancer, organ transplant, or chronic use of oral immunosuppressive agents).
6. Any reason the investigator feels the patient should not participate in the study
Anterior Tibial Subluxation in the Setting of ACL-injury and After ACL Reconstruction

To identify the related factors for anterior tibial subluxation (ATS) on anterior cruciate ligament-injured MRI images.

Demographic data and MRI images of anterior cruciate ligament-injured patients were retrospectively analyzed. Anterior tibial subluxation was measured and factors were examined via univariate and multivariate analysis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed anterior cruciate ligament injuries
* Available preoperative MRI images at our hospital

Exclusion Criteria:

* Patients were excluded in the case of under 18 years of age
* Bilateral anterior cruciate ligament injuries
* Concomitant posterior cruciate ligament injuries
* Concomitant collateral ligament injuries
* No access to the preoperative MRI scan at our hospital
Expression of Angiogenic Biomarkers During Healing of Intra-Oral Soft Tissue Engineered Grafts

The purpose of this observational research study is to understand more about wound healing of gum tissue. This study was the biomarker study of a small cohort of study participants derived from NCT01547962 (completed). Two surgical sites of each patient were randomly selected to receive CelTx™ as a donor material in one site and conventional autograft using keratinized tissue from the palate as the donor material at the contralateral (opposite side) site. Fluids collected from between a tooth and the gum and directly from wounds contain proteins that occur in different levels as the wound healing process proceeds. In this research study wound fluid will be collected from the donor palate site (roof of your mouth) and the treated sites on your gum before and after placement of CelTx and conventional treatment (tissue from the roof of your mouth) to measure which proteins and how much of each are present during the first 4 weeks of wound healing.

In a clinical trial designed to evaluate the safety and effectiveness of rhPDGF-BB to promote soft and hard tissue engineering of the periodontium, the subjects provided gingival crevicular fluid (GCF) or periodontal wound fluid (WF) and the results demonstrated contrasting inducible expression patterns of PDGF-AB, VEGF, and ICTP during periodontal healing \[17, 24, 25\]. However, little is known regarding the release of these molecules into local periodontal wound fluid during tissue-engineered grafts.

The aim of this study is to determine the presence and influence of angiogenic biomarkers, such as PDGF, VEGF, and FGF, involved in the wound healing process of tissue engineered grafts in the treatment of subjects (with recession-type defects) who have an insufficient zone of attached gingival associated with at least two nonadjacent teeth.

STUDY OBJECTIVES The purpose of this pilot study is to compare the expression of angiogenic biomarkers involved in the wound healing process of 2 different periodontal surgical approaches: 1) CelTx™ (living bilayered cell therapy product) and 2) free gingival grafts

Eligibility Criteria:
Inclusion Criteria:

* Subject has signed informed consent to participate in Organogenesis Clinical Protocol 06-PER-002-CTX.
* Subject has signed informed consent to participate in this adjunct bio-marker study.
* Subject is willing to comply with the additional study visits at weeks 2 and 3 as required by this study.

Exclusion Criteria:

- Subject requires antibiotic prophylaxis for routine dental procedures.
The Effect of Stress Ball Application Before Coronary Angiography on Stress, Anxiety and Vital Signs

It aimed to examine stress, anxiety and resorting to life paths to enable researchers to contain this stress.

Stress and anxiety lives of patients before coronary angiography. The stress and anxiety they experience also affect their vital signs. The researchers aimed to examine the ways the stress ball affected their patients' stress, anxiety, and vital signs.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and over
* For those who will undergo coronary angiography for the first time
* Able to read and write
* Not diagnosed with anxiety disorder and not using medication for it
* No physical disability to use the stress ball
* Cognitive health levels consist of individuals who are suitable for answering data collection forms.

Exclusion Criteria:

* Unconscious and not fully oriented
* Sight and hearing problems
* Alzheimer's disease and other types of dementia
* Having a severe psychiatric problem that cannot answer the questions
* Those who came with MI (myocardial infarction) and performed CAG
* Individuals who are closed to communicating are not included in this study.
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis B Who Have Failed Antiviral Treatment With Nucleoside (Nucleotide) Analogues

This observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with nucleoside (nucleotide) analogues. Data will be collected from patients treated according to the current Summary of Product Characteristics and local standard of care and regulations during 48 weeks of treatment and 24 weeks of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Positive HBsAg for more than 6 months before assignment to treatment with Pegasys
* Detectable HBV DNA (as measured by PCR)
* HBeAg positive and negative patients
* Patients previously treated with nucleoside (nucleotide) analogues who have failed antiviral treatment and have been assigned to treatment with Pegasys according to the local therapeutic standard
* Elevated serum alanine aminotransferase (ALT)
* Chronic hepatitis B confirmed by liver biopsy or non-invasive assessment (FibroScan), ARFI, FibroTest) or by clinical evaluation

Exclusion Criteria:

* Contraindications to treatment with Pegasys according to the Summary of Product Characteristics
* Hepatocellular carcinoma and/or severe hepatic dysfunction or decompensated cirrhosis of the liver
* Immunosuppression, immunomodulatory or chemotherapy within the last 6 months prior to start of Pegasys treatment
* Planned other than Pegasys antiviral treatment during Pegasys therapy
* Chronic liver disease other than chronic hepatitis B
* Pregnant or breast-feeding women
* Inadequate hematologic function
* Autoimmunology disorders
* Co-infection with chronic hepatitis C or HIV
Pharmacokinetic Study of Subcutaneous Testosterone Enanthate

Evaluation of pharmacokinetics of subcutaneous testosterone enanthate

Evaluation of pharmacokinetics and safety profile of testosterone enanthate injected subcutaneously via auto-injector in healthy male volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male subjects, 18-55 years of age, inclusive, at the time of signing the informed consent;
* Body weight ≥50 kg and body mass index within the range 19-30 kg/m2, inclusive, at screening;
* Medically healthy subjects with clinically insignificant screening and check-in results (medical history, 12-lead electrocardiogram \[ECG\], physical examination, and laboratory tests); and
* Subjects who are able to understand and are willing and able to give their signed informed consent before any trial-related procedures are performed.

Exclusion Criteria:

* Currently diagnosed or a history of asthma, urticarial, angioedema, anaphylaxis, atopic dermatitis, clinically significant abnormality of skin of the abdomen, cancer, diabetes, or any other clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, hematological, dermatological, venereal, neurological, psychiatric, or other major disorders;
* History of benign prostate hypertrophy (BPH), prostate cancer, or abnormal prostate specific antigen (PSA) values;
* PSA level \> 3 ng/ml at screening;
* Presence or history of gastrointestinal, hepatic or renal disease, or any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines;
* Systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 40 to 90 mmHg, and/or pulse rate outside the range of 40 to 100 beats per minute after one repeat at screening or check-in;
* Abnormal ECG at screening as judged by the Investigator;
* History of clinically significant drug and/or food allergies as determined by the Investigator;
* Allergy to sesame, sesame oil, or a history of hypersensitivity or idiosyncratic reaction to compounds related to the study drug
* Subjects undergoing current treatment with other androgens (i.e. dehydroepiandrosterone \[DHEA\]), anabolic steroids, other sex hormones, or drugs that interfere with the metabolism of testosterone (i.e. opioids, anastrozole, clomiphene, dutasteride, finasteride, flutamide, ketoconazole, spironolactone, and testolactone);
* Subjects treated within the past 12 months with estrogens, gonadotropin releasing hormone (GnRH) agonists, or growth hormone;
* Prescription, over the counter medications, vitamins, herbal and dietary supplements taken within 7 days or 5 half-lives (whichever is longer) prior to the dose of study medication and duration of the study;
* Positive screen for human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C at screening;
* Positive urine screen for drugs of abuse (amphetamine, barbiturates, benzodiazepines, cocaine, marijuana, methadone, methamphetamines, oxycodone, and opiates) or positive breath alcohol test at screening and check-in
Asthma, Inflammation and G Protein-coupled Receptors (GPCR)

The G protein-coupled receptors (GPCRs) are a family of proteins expressed at the cell membrane. They are composed of 380 members involved in the important functions of the organism and are privileged therapeutic targets.Their expression is highly modulated depending on the metabolic state of the cells, in particular in pathological situations.our study proposes to determine whether GPCR expression modulation could be used as a biomarker, either prognostic or diagnostic, of treatments.To do so , the investigators will determine the expression profile of the 380 human GPCRs in human blood cell samples in two chronic inflammatory pulmonary diseases : asthma and COPD (chronic obstructive pulmonary disease ) . These have opposed inflammatory infiltrates : asthma is associated with eosinophil and Th2 lymphocyte infiltration whereas COPD shows neutrophils and macrophages within the airways with a Th1 lymphocytic population. The GPCR signature (transcriptomic) will be determined on total white blood cells as well as on isolated mono- and poly-nuclear populations obtained from healthy subjects and patients selected at the asthma or COPD consultation. The expression profiling analysis will reveal sub-groups of GPCRs whose expression is modified in disease. The specificity of the variation of expression of these biomarker sub-populations will be determined, by a study recruiting a hundred patients and controls per disease on this restraint number of genes. The outcomes of the project will lead to establish GPCR "identity cards" for these chronic inflammatory diseases, which might therefore be used as diagnostic or prognostic biomarkers to follow the evolution of a disease or the efficacy of a given treatment. In addition, detailed analysis of the identified GPCRs will lead to propose new therapeutic targets for inflammatory diseases. This study has therefore the objective of validating GPCRs as potential biomarkers for inflammatory diseases.

Multicentre non-randomized

Eligibility Criteria:
Inclusion Criteria:

* Asthma group
* COPD group
* Control group

Exclusion Criteria:

* Patients with infection or inflammatory diseases
Blood Recirculation and vvECMO

A prospective, observational study will be performed measuring recirculation of blood through a veno-venous Extracoporeal Membrane Oxygenation (vvECMO) in patients with acute respiratory distress syndrome (ARDS) on vvECMO. ECMO blood flow will be adjusted with respect to recirculation.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 years or older
* ARDS
* veno-venous ECMO

Exclusion Criteria:

* age \< 18 years
* hemodynamic instability during measurement of recirculation
* pregnancy
* inability to obtain patient's consent or consent of legal guardian
Efficacy of Lumiracoxib in Relieving Moderate to Severe Post-dental Surgery Pain, Compared to Both Placebo and Celecoxib

This study will assess the safety and efficacy of lumiracoxib 400 mg in relieving moderate to severe post-dental surgery pain, compared to both placebo and celecoxib 400 mg.


Eligibility Criteria:
Inclusion Criteria:

* Requiring extraction of two or more partially impacted or fully bony impacted third molars. At least one of the extractions must be mandibular
* Moderate to severe post-dental surgery pain intensity (as rated by the patient on the categorical pain intensity scale within five hours of surgery

Exclusion Criteria:

* Evidence or history of any cardiac and cerebral thrombotic/ ischemic diseases and/ or events

Other protocol-defined inclusion/exclusion criteria may apply
Reviving Early Diagnosis of Cardiovascular Disease in the Utrecht Health Project

The goal of this randomized trial is to compare the diagnostic yield of a screen-like early diagnosis strategy to usual primary care to detect coronary artery disease (CAD), atrial fibrillation (AF), heart failure (HF), and/or valvular heart disease (VHD) in community people aged 50-80 years who participate in the Utrecht Health Project.

The diagnosis strategy consists of a questionnaire with questions related to symptoms suggestive of CAD, AF or HF, a focused physical examination, laboratory testing, electrocardiography, and echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* Aged 50-80 years
* Being a participant of LRGP
* Having indicated in the LRGP informed consent to be interested in participating in further research.

Exclusion Criteria:

* Diagnosed with coronary artery disease and atrial fibrillation and heart failure.
* Undergoing major (cardiovascular) surgery, and/or revascularisation therapy and/or transplantation treatment within 3 months after enrolment.
* Not willing to give written informed consent for RED-LRGP.
* Not allowing incidental findings to be reported to him/herself or their own GP.
Intraoperative Hypotension and Metabolomics in Major Upper Gastrointestinal Surgery

We will investigate the effect of hypotension prediction index guidance on intraoperative hypotension and metabolomics in patients undergoing major upper gastrointestinal surgery

Intraoperative hypotension (IOH) has been shown to increase the risk of postoperative morbidity and mortality. The Hypotension prediction index (HPI) guidance is an algorithm that can predict impending hypotension, defined as mean arterial pressure below 65mmHg. Patients undergoing major upper abdominal surgery are at high risk of IOH occurrence, because the surgical procedures involve organ removal like intestinal resection and vessel or organ anastomoses or reconstruction, often associated with high blood loss. However, the effectivity of applying HPI for reducing the duration and severity of IOH and postoperative morbidity and mortality in short term within 30 days after surgery and long term within 1 year remains inconclusive.

Postoperative ileus (POI) generally defines absence of flatus within 72 hours after surgery. POI is known as the most important factor to slow patient recovery, increase postoperative morbidity and prolong the hospital stay following major upper abdominal surgery. Metabolomics can investigate the small molecule changes in response to certain stimulus, such as different environments. Metabolomics involves the comprehensive analysis of metabolites. In recent years, metabolomics has several applications in the early diagnosis and prevention of health and disease. However, the association between the POI occurrence and the metabolites in the presence and absence HPI guidance have not yet been investigated.

The proposed strategy and specific objectives of this 2 years project using a randomized controlled trial are as the follows:

1. To clarify the relationship of POI occurrence to presence and absence of HPI guidance
2. To Explore differences in metabolites in presence or absence of HPI guidance.
3. Explore the potential metabolites associated with POI in different intraoperative environment in using HPI and no HPI guidance.

Eligibility Criteria:
Inclusion Criteria:

* elective upper gastrointestinal surgery

Exclusion Criteria:

* no laparoscopic surgery
Acupuncture and Escitalopram for Treating Major Depression Clinical Study

We will be able to investigate in a sample of patients free of antidepressants whether acupuncture is more effective than placebo.

This is a multicenter, randomized, controlled, 2 by 2 factorial clinical trial for Major depression.

Eligibility Criteria:
Inclusion Criteria:

1. Between 18 and 75 years of age with no gender-based restriction.
2. Fulfilling the diagnostic criteria of DSM-5 for major depressive disorder.
3. A Hamilton Rating Scale for Depression (HDRS-17) score ≥ 17
4. Ability to read and understand Mandarin Chinese, at least nine years of education, and willingness to adhere to the study protocol.
5. The absence of acupuncture treatment within at least 1 year.
6. Willingness to participate in the trial and provide written informed consent for the clinical trial.

Exclusion Criteria:

1. Lifetime or current neuropsychiatric conditions, such as bipolar disorder, schizophrenia, substance dependence or abuse, dementia, brain injury, epilepsy and so forth.
2. High suicide risk or presenting with suicidal ideation (a score of more than 2 points on the Suicide question of the HDRS-17) at the time of entry.
3. Medicated with antidepressant at the start of the trial or history of treatment failure to escitalopram.
4. Pregnancy or breastfeeding.
5. Subjects who have acute inflammation at the planned acupuncture site on the body or any other contraindication to acupuncture.
6. Candidates afraid of needles in general and reluctant to receive acupuncture in particular
7. Known or suspected clinically unstable systemic medical disorder (including cancer, organ failure, or severe diseases of the cardiovascular, severe hepatic or renal insufficiency).
8. Previous participation in other acupuncture trials.
Clinical Trial of a Computer-driven Weaning System for Patients Requiring Mechanical Ventilation

The purpose of this study is to compare the efficacy of a computer-assisted ventilator weaning system (Drager Smartcare) to our current standard of care in the medical intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Initiated on mechanical ventilation via endotracheal tube
* Admitted to Medical Intensive Care Unit and Medical Intensive Care Unit Team (Harrison Avenue Campus, Menino Pavilion)
* Requiring mechanical ventilation for more than 48 hours
* Meets prespecified weaning criteria

Exclusion Criteria:

* Do Not Resuscitate/Do Not Intubate order
* Pregnancy
* Mechanical ventilation initiated at another hospital
* Cardiac arrest for more than 5 minutes with poor neurologic prognosis
* Tracheostomy
AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding

In this before-after multicenter study the authors tested the hypothesis that the prophylactic use of aprotinin compared to tranexamic acid could reduce the proportion of patients presenting severe perioperative bleeding.

Perioperative bleeding remains a real challenge for physicians managing cardiac surgical patients. In patients at high risk for excessive bleeding the prophylactic use of antifibrinolytics may be useful. This study propose to compare the efficacity and innocuity of aprotinin and tranexamic acid to reduce the proportion of patient presenting severe peri-operative bleeding according the Universal Definition of Perioperative Bleeding (UDPB) classification.

Eligibility Criteria:
Inclusion Criteria:

patients undergoing cardiac on pump surgery at high risk for bleeding defined by :

* Aorto-coronary bypasses surgery (2 or more) under dual platelet aggregation therapy (Primary or redo)
* Heart transplant (Primary or Redo)
* Infectious endocarditis (Primary or Redo)
* Ascending acute aortic dissection (Primary or Redo)
* Artificial heart / LVAD under CEC (Primary or Redo)
* Combined surgery, Redo
* Ascending aorta surgery, Redo

Exclusion Criteria:

* Off pump cardiac surgery
* Patient not meeting the inclusion criteria
* Patient not receiving antifibrinolytic therapy
* Patient with absolute contraindication to antifibrinolytics,
* Patient refusing to give access to their medical chart,
* Patient not meeting the inclusion criteria
* Patient protected by the law, under guardianship or trusteeship,
* Patient deprived of liberty