cyrilzakka/clinical-trials huggingface dataset:
Trabeculopuncture as Predictive Test for the Success of Ab Interno Trabeculectomy

The purpose of this study is to perform trabeculopuncture a test to determine the distal outflow tract function to predict the success of ab interno trabeculectomy.

The aim of this study is to develop a non-invasive predictive test for the function of the distal outflow tract after ab interno trabeculectomy for open angle glaucoma. We hypothesize that the ocular pressure drop and outflow change after preoperative trabeculectomy may predict the success of ab interno trabeculectomy. The results of this study should allow trabeculopuncture to be used to select the most appropriate procedure for the individual patient.

Eligibility Criteria:
Inclusion Criteria:

* individuals ≥ 18 years of age
* clinical diagnosis of: primary open angle glaucoma, pigmentary glaucoma, or pseudoexfoliation glaucoma
* uncontrolled intraocular pressure (IOP) with maximally tolerated medical therapy
* progressive thinning of retinal nerve fiber layer assessed by Spectral domain optical coherence tomography (p \< 0.05)
* progression of visual field defects
* visually significant cataract and indication to reduce IOP or glaucoma medication burden

Exclusion Criteria:

* clinical diagnosis of neovascular glaucoma, angle-closure glaucoma, uveitic glaucoma, neovascular glaucoma
* prior glaucoma surgery
* preexisting conditions affecting the episcleral venous pressure including Grave's ophthalmopathy, Sturge-Weber syndrome, Arteriovenous fistulas (carotid-cavernous fistula)
Mechanisms of Social Inequalities in Post-hospitalization Rehabilitation in Patients With Acute Coronary Syndrome

Aim: To identify psychological and socioeconomic predictors of cardiac-rehabilitation (CR) attendance and uncover mechanisms of CR non-attendance.

Design: Quantitative, observational, prospective study. Hypothesis a: Educational-level, comorbidity, anxiety, depression, self-efficacy, cohabitation and distance from residence are predictors of CR attendance.

Hypothesis b: The expected social gradient in CR attendance is explained partly by differential exposure of comorbidity, anxiety, depression, self-efficacy, cohabitation and distance to the rehabilitation clinic.

Design: Quantitative, observational, prospective study. Self-administrated questionnaires, medical journals and telephone interviews will be used for data collecting.

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized with acute coronary syndrome (ACS) to Nordsjællands Hospital (ICD10: DI210-DI219, DI200, DI200B, DI200C, DI23, DI24) will be invited to participate in the survey as an ongoing process during the inclusion period (N=267).

Exclusion Criteria:

* Patients who are not able to submit written consent are excluded. Thus, patients with severe cognitive dysfunction or poor language skills are excluded.
Establish a Specific Cohort Database for Depressive Disorders

Depression is characterized by high prevalence, high recurrence rate, high disability rate, high suicide rate, and heavy disease burden. However, the diagnosis, treatment, and prognosis of depression are difficult to meet the clinical needs at present. This study plans to integrate a large sample of hospital clinical data, laboratory examination data, brain imaging, and electrophysiological data, as well as audio-visual data, to establish a database for depressive disorder, and long-term follow-up to form a specific disease cohort. This study will provide a scientific basis for exploring biomarkers related to objective diagnosis and treatment of depression.

Together with three tertiary hospitals in Shanghai, Shanghai Tenth People's Hospital, Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine, and Zhongshan Hospital affiliated to Fudan University, Shanghai Mental Health Center will take a lead to establish a big database focused on depressive disorders. Expert consensus will be used to determine the standard for the dataset. Real-world data will be include. To establish a depressive disorders-specific database with multiple functions, such as data insight, data retrieval, cohort project establishment, follow-up, and statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75
* Meeting ICD-10 depressive episode criteria (F32, F33, F34, F38, F39)
* Cultural, social and educational background sufficient to understand informed consent and research content
* Agree to participate in this study

Exclusion Criteria:

* Exclude other mental disorders such as bipolar disorder and schizophrenia (but not comorbidities)
* Patients with a history of brain injury or cerebrovascular accident, myocardial infarction, severe liver cirrhosis, acute and chronic renal failure, severe diabetes, aplastic anemia, moderate and severe malnutrition and other serious physical diseases of the nervous, heart, liver, kidney, endocrine and blood systems
An Internet-based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)

The purpose os this study is examine the effect and feasibility (usability and satisfaction) of an iCBT (GROw program) for adults with PGD

The death of a loved one has physical, psychological, and social consequences. Between 9.8 and 21.5% of people who lose a loved one develop Prolonged Grief Disorder (PGD). Internet- and computer-based interventions (i.e., Internet-delivered Cognitive-Behavioral Therapy, iCBT) are cost-effective and scalable alternatives that make it possible to reach more people with PGD. The main goal of the present investigation was to examine the effect and feasibility (usability and satisfaction) of an iCBT (GROw program) for adults with PGD. A secondary objective was to detect adherence to the app (Emotional Monitor) used to measure daily grief symptoms. The study had a single-case multiple-baseline AB design with six participants. The GROw program is organized sequentially in eight modules, and it is based on the dual-process model of coping with bereavement. Evaluations included a pre-to-post treatment assessment of depression, grief symptoms, and typical grief beliefs, along with daily measures of symptom frequency and intensity on the Emotional Monitor App. Treatment opinions and adherence to the App were also collected. Efficacy data were calculated using a Nonoverlap of All Pairs (NAP) analysis and Reliable Change Index (RCI).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Meeting diagnostic criterio for PGD
* Sign an informed consent
* Ability to understand and read Spanish
* Abilitiy to use a computer and having access to the Internet
* Having an e-mail address

Exclusion Criteria:

* Presence of risk of suicide or self-destructive behaviors
* Presence of another severe mental disorder (substance abuse or dependence, pshychotic disorder, dementia o bipolar disorder)
* Presence of severe personality disorder
* Presence of a medical condition whose severity or characteristics prevent the performance of treatment
* Receiving other psychological treatment during the study for PGD
* An increase and/or change in the medication during the study period
Neuromusculaire Monitoring Survey

This survey aims to better define the willingness-to-buy for Applications in Neuromuscular Monitoring throughout European hospitals.

This study consists of a simple online survey that takes approximately 2 minutes to complete.

The study aims to assess the willingness-to-buy for Applications in Neuromuscular Monitoring (monitoring and software-based) within the anesthesia departments of European hospitals. The survey is targeted to the department heads of the questioned anesthesia departments.

Eligibility Criteria:
Inclusion Criteria:

* Active Anesthesiology department heads of European Anesthesiology departments.

Exclusion Criteria:

* None
Prevention of Dental Caries Lesions With Fluoride Varnish in Erupting First Permanent Molars

The aim of this study is to determine the effectiveness of fluoride varnishes in the prevention of dental caries lesions in erupting permanent first molars, in high-risk patients. Using as reference ICDAS criteria, when the success means that the surface maintain an ICDAS value 0 and failure that has change in ICDAS value 0 to 1.

Sample: The sample comprise 180 patients between 6-7 years old with high-risk of dental caries.

Study design: It proposed an experimental design randomized into 3 groups according to the frequency of topical fluoride application.(Group A: every 6 month; Group B: every 3 month; Group C: positive control).


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent from parents.
* Child assent
* High risk of dental caries
* At least one sound first permanent molar (ICDAS=0)

Exclusion Criteria:

* Bad behaviour
* Any systemic condition, disability
Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III non-seminomatous germ cell tumors.

OBJECTIVES:

* Compare progression-free survival rates of patients with poor prognosis stage II or III non-seminomatous germ cell tumors with an unfavorable decrease of tumor markers after treatment with 1 course of bleomycin, etoposide, and cisplatin followed by subsequent treatment with 3 additional courses of bleomycin, etoposide, and cisplatin OR dose-dense sequential combination chemotherapy.
* Compare overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study.

Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients with a favorable decrease of tumor markers after 1 course of BEP receive 3 additional courses of BEP. Patients with an unfavorable decrease of tumor markers after 1 course of BEP are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive 3 additional courses of BEP.
* Arm II: Patients receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.

PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of non-seminomatous germ cell tumors (NSGCT) as evidenced by 1 of the following criteria:

  * Histologically confirmed NSGCT
  * Clinical evidence of disease AND high serum human chorionic gonadotropin (HCG) or alpha-fetoprotein (AFP) levels
* Clinical stage II-III disease (disseminated disease)
* Testicular, retroperitoneal, or mediastinal primary site
* Poor prognosis disease, meeting 1 of the following criteria:

  * Mediastinal primary site
  * Non-pulmonary visceral metastases
  * One of the following lab values:

    * HCG \> 50,000 UI/L
    * AFP \> 10,000 ng/mL
    * Lactate dehydrogenase \> 10 times upper limit of normal (ULN)

PATIENT CHARACTERISTICS:

Age

* Over 16

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* Bilirubin ≤ 1.5 times ULN

Renal

* Creatinine clearance \> 60 mL/min

Other

* No other prior malignancy except basal cell skin cancer
* No HIV positivity

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome

The aim of this study is to explore the microRNA profile in serum of women with Polycystic Ovary Syndrome and investigate the correlation between the microRNA profile and markers of metabolic syndrome.

The study consist of 2 parts:

1. A cross-sectional study of a cohort of women with PCOS with analysis of materials from the established biobank. (the PICOLO cohort) Data and blood samples from 266 women with PCOS was collected from January 2010 - February 2013 as a part of the PICOLO collaboration: "PCOS, infertility, Cardiovascular and Obstetric risk markers and Long-term Outcome" at Holbaek Fertility Clinic and at Herlev Hospital.

   Serum samples will be analysed with Reverse Transcript polymerase chain Reaction (RT-qPCR) for selected microRNAs.
2. A follow-up study of local participants from the PICOLO study. 90 of the participants were recruited at Holbaek Fertility Clinic.

Following tests will be performed at reexamination, in order to describe the clinical phenotype: Health interview, anthropometrics, acne score, Ferriman-Gallway score, blood pressure, Transvaginal ultrasound of uterus and ovaries, insulin Resistance (IR) assessed with Oral glucose Tolerance test (OGTT), Venous blood for hormone analysis and lipid status.

MicroRNA analysis with Taqman microRNA array will be performed on serum samples.

Detection and treatment of women with PCOS is a challenge due to the variability of the syndrome. If MiRNA could serve as marker of metabolic syndrome, it would be possible to detect and follow the women of greater risk at an earlier stage, and thereby preventing morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 40 years when included in the PICOLO study
* PCOS based on the Rotterdam 2003 consensus criteria

Exclusion Criteria:

* Contraceptive pills within 8 weeks from examination,
* endocrinological disease (i.e. type 1 diabetes thyroid dysfunction),
* Severe endometriosis (stage III and IV)
* Premature ovarian insufficiency,
* Breastfeeding women and
* Pregnancy.
The Scanner in the Coronary Evaluation

Conventional coronary angiography is the recommended procedure in detection of coronary stenosis in patients with heart valve disease referred for surgery.The aim of this prospective study is to assess diagnostic accuracy of multislice spiral computed tomography coronary angiography in patients with heart valve disease referred for surgery.

The diagnostic accuracy of multislice spiral computed tomography coronary angiography in terms of sensitivity, specificity, negative and positive predictive value, the conventional coronary angiography being the gold standard.50 patients scheduled for valve surgery will be screened to conduct an additional multislice spiral computed tomography.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for valve surgery who need a conventional coronary angiography
* Informed Content
* Patients affiliated to the social security system

Exclusion Criteria:

* Instable condition
* Arrhythmia including atrial fibrillation
* Impaired renal function
* Known contrast allergy
* Patients unable to hold an apnea during 20 seconds
* Pregnancy
* Emergency
* People unable to sign the informed content such as major under supervision
Evaluation of the CapScan Device to Measure the Metabolism of Sulfasalazine

Evaluation of the CapScan intestinal collection device in characterizing the metabolism of sulfasalazine in the digestive tracts of healthy volunteers.

The objective is to evaluate the effectiveness of the CapScan intestinal collection device in characterizing the regional distribution of sulfasalazine, the metabolic breakdown products of sulfasalazine, and the gut microbiota in the digestive tracts of healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Males or females 18 years of age or older and 70 years of age or younger at the time of the first Screening Visit.

Physical Status Classification System 1 or 2. For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit and agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 14 days after the final dose of sulfasalazine.

Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form

Exclusion Criteria:

* • Known or suspected gastrointestinal obstructions, strictures or fistula

  * Known or suspected moderate to severe dysmotility, by the judgement of the principal investigator
  * Gastroparesis
  * A swallowing disorder
  * Known intolerance, reaction or hypersensitivity to sulfasalazine, its metabolites, sulfonamides, or salicylates
  * Urinary obstruction
  * Porphyria
  * Glucose-6-phosphate dehydrogenase deficiency
  * Known or suspected infection with severe acute respiratory syndrome, HIV, hepatitis B virus or hepatitis C virus
  * Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding.
  * Use of concomitant medications, such as aspirin, antibiotics, laxatives and proton pump inhibitors that may interfere with the study in the judgement of the investigator.
  * Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the principal investigator, to interfere with the conduct of the study.
  * A clinical condition that, in the judgment of the principal investigator, could potentially pose a health risk to the subject while involved in the study
Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma

Bortezomib (Velcade) has just recently been approved by the FDA for the treatment of multiple myeloma in patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. This study will determine if Velcade is effective in treating patients with multiple myeloma that have had no prior treatment for the disease. We will also use whole-genome scanning to identify drug response biomarkers in bone marrow samples as well as nerve fiber studies to compare nerves prior to the use of Velcade and after treatment with Velcade.

Primary Objective

• To evaluate the objective response rate (CR + PR) to bortezomib alone in patients with newly diagnosed multiple myeloma.

Secondary Objectives

* To evaluate the tolerability and toxicity.
* To evaluate time to progression.
* To assess the frequency and severity of peripheral neuropathy.
* To evaluate the impact of early intervention with dose modification and explore symptomatic treatment of peripheral neuropathy.

Exploratory Objectives

• To perform pharmacogenomic analysis of molecular markers associated with response or non-response.

Statistical Design A one stage design is used to evaluate ORR. With 60 evaluable participants, if at least 27 objective responses are observed then bortezomib will be considered promising. The probability of concluding the treatment promising is \>0.95 with a true ORR of 55% and \<0.07 with a true ORR of 35%.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple myeloma based upon standard criteria
* Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of \> 1 g/dl and/or urine monoclonal immunoglobulin spike of \> 200mg/24 hours.
* Karnofsky performance status of \> 60
* Hemoglobin \> 8.0 g/dL
* AST (SGOT) \< 3 x ULN
* ALT \< 3 x ULN
* Total bilirubin \< 2 x ULN
* Is infertile or is practicing an adequate form of contraception
* 18 years of age or older

Exclusion Criteria:

* Prior treatment with systemic chemotherapy
* Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes
* Plasma cell leukemia
* Calculated or measured creatinine clearance \< 30 mL/minute within 14 days of enrollment
* Grade 2 or greater peripheral neuropathy
* Hypersensitivity to bortezomib, boron or mannitol
* Severe hypercalcemia
* HIV positive
* Known active hepatitis B or C
* New York Hospital Association Class III or IV heart failure
* Second malignancy requiring concurrent treatment
* Other serious medical or psychiatric illness
* Pregnant women
* Dialysis dependent patients
A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis

The purpose of this study is to provide an initial evaluation of the effectiveness of BMS-986278 in participants with lung fibrosis, to demonstrate the safety of BMS-986278, and provide information on the drug levels of BMS-986278 in these participants.


Eligibility Criteria:
Inclusion Criteria:

For the idiopathic pulmonary fibrosis (IPF) Cohort

* Diagnosis of IPF within 7 years of screening
* Female and males ≥ 40 years of age

For the progressive fibrotic interstitial lung disease (PF-ILD) Cohort

* Evidence of progressive ILD within the 24 months before screening
* Female and male ≥ 21 years of age.

Exclusion Criteria:

* Women of childbearing potential (WOCBP)
* Active Smokers
* Current malignancy or previous malignancy up to 5 years prior to screening
* History of allergy to BMS-986278 or related compounds

Other protocol-defined inclusion/exclusion criteria apply
The PCI Choice Trial: a Pilot Randomized Trial of a Decision Aid for Patients With Stable Coronary Artery Disease

Despite several large clinical trials clearly establishing that coronary revascularization (i.e. percutaneous coronary intervention - PCI) does not prolong survival or prevent myocardial infarction (MI) for stable coronary artery disease (CAD), patients with stable angina continue to believe that PCI is performed to improve these outcomes. Additionally, recent concerns have emerged of overuse of PCI among patients with little or no angina. Thus there is a compelling need to share with patients the risks and benefits of PCI prior to treatment to reach an informed decision.

This study is designed to answer the question of whether a decision aid can improve patient knowledge, decisional conflict and patient satisfaction with decision-making compared to usual care for the treatment of stable angina.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stable angina - As judge by clinician, eligible for medication therapy or PCI - agree to be available for follow-up survey 3 months after treatment decision

Exclusion Criteria:

* has major communication barrier (severe hearing/vision impairment, dementia, cannot communicate with clinician in English)
Study of Chronic Rhinosinusitis Symptoms in Asthma Patients Undergoing Treatment With Reslizumab

The primary objective of this research is to monitor chronic rhinosinusitis (CRS) symptoms in asthma patients who are undergoing treatment with reslizumab. A secondary objective is to explore whether there are sub-populations that appear to benefit or not benefit from reslizumab in terms of their CRS symptoms.

This is a prospective observational study of patients receiving reslizumab to treat their asthma. Some asthma patients receiving reslizumab also have CRS, which might also be improved by this drug. Study measures will be obtained from the medical records of eligible subjects who consent to participate. The study has no specific procedures per se, because all study measures are acquired during the course of standard of care treatment and will be abstracted from those medical records.

Eligibility Criteria:
Inclusion Criteria:

* Age is 18 years or older
* Physician diagnosis of poorly controlled moderate to severe asthma despite typical medical therapy with an eosinophilic phenotype (defined by blood eosinophil count of 150 µL or greater within 6 weeks of enrollment)
* Initiating or undergoing reslizumab therapy (Reslizumab - Patient Information listed in Appendix 1 for reference)
* Physician diagnosis of chronic rhinosinusitis with nasal polyposis
* Able to understand and willing to provide informed consent
* Able to complete standard of care English-language questionnaires

Exclusion Criteria:

* Current smokers
* Significant uncontrolled medical conditions
* Ongoing malignancy or history of cancer in remission for less than 12 months
* Subjects who had received immunosuppressive medications within 3 months of enrollment