cyrilzakka/clinical-trials huggingface dataset:
The iHealth Study in College Students

The objective of this project was to test the feasibility of electronic mail recruitment and web screening for hazardous drinking, to compare different approaches to encouraging screening, and to estimate the effects of minimal and more extensive feedback in preparation for a future alcohol web-based brief intervention study

This pilot study aims to test the feasibility of electronic mail recruitment and web screening for alcohol problems, to compare different approaches to encouraging screening, and to estimate the effects of minimal and more extensive feedback in preparation for a future alcohol web-based brief intervention study. To do so, 4300 freshman adult college students will be randomized to receive an electronic mail request to complete a web alcohol screening test using an alcohol-specific or a general wellness approach. The primary outcome is the proportion of respondents who complete alcohol screening. Additional outcomes include readiness to change drinking, help-seeking, alcohol consumption and consequences. The results of this pilot study will provide information useful to 1) colleges deciding how best to implement universal screening for hazardous alcohol use, and 2) in the preparation of a larger study of web-based screening and brief intervention for hazardous drinking in college students.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Full time student
* College freshman

Exclusion Criteria:

-
Prostate Cancer Prevention Trial With Quercetin and Genistein

The aim of the randomized controlled double-blind crossover trial is to evaluate the effectiveness of two dietary supplements containing polyphenolic phytochemicals (isoflavonoid genistein and flavonoid quercetin) in comparison with placebo on the rate of increase in prostate-specific antigen (PSA). In addition, secondary objective is to evaluate the incidence of prostate cancer and to analyze malondialdehyde and protein carbonyle as indicators of the oxidative status.

Prostate cancer (PC) is the most frequently occurring cancer in men. Its clinical incidence and mortality rates vary geographically, being much lower in Asia than in Western countries. Notably, latent PCs seem to be equally distributed, thus supporting the hypothesis, that environmental factors may be important in prostate cancer progression. Moreover, epidemiological evidence strongly supports the concept that the incidence of clinical prostate cancer depends on lifestyle factors, mainly related to diet. The isoflavone genistein and the flavonoid quercetin have been identified as likely preventive candidates. The aim of the intended clinical trial is to evaluate the hypothesized effectiveness of polyphenolic phytochemicals with highly purified dietary supplements in patients at high risk of clinical PC and without systemic treatment. This will provide data, which serve as an important pre-requesite for targeted dietary interventions using alternative medicine as preventive measures in men with latent PC.

Eligibility Criteria:
Inclusion Criteria:

* Patients with deviant PSA constellation:

  1. Patients with PSA 2,5 - 4 μg/l and free PSA/total PSA \< 15 %
  2. Patients with PSA \> 4 μg/l with negative punch biopsy of the prostate

     Exclusion Criteria:
* chronic liver diseases, impaired kidney function
* inflammatory diseases of the urogenital tract
* history of malignancy of any organ system, treated or untreated, within the past three years whether or not there is evidence of local recurrence or metastases
* therapy with Doxazosin, Dutaserid and/ or Finasterid, Testosteron and other hormonal active medicaments
* inflammatory bowel diseases
* malabsorption/-digestion
* hypersensitivity/allergy to soy
* phytotherapy or intake of dietary supplements
* smoker
* abnormal clinical laboratory values at baseline
* participation in any other trial with an investigational new drug
* inability to sign informed consent
Ergonomics in Ultrasound Procedures

The study will compare two different positions of the ultrasound machine during simulated CVC positioning.

The position of the ultrasound machine will be randomized. Group A will perform the procedure with the ultrasound monitor facing them, while subjects randomized to group B will perform the procedure with the ultrasound machine positioned at a 90° angle to their visual axis.

We will recruit medical trainees affiliated with the 'Anesthesia and Intensive Care' and 'Emergency Medicine' schools. Data collected for each participant will include: age, gender, specialty school, year of specialization training, expertise in using ultrasound for ultrasound-guided procedures. Once informed consent is obtained, subjects will be divided through simple randomization (a list generated in advance with Excel and subjected to the opaque envelope method) into two groups: A and B. All subjects will be asked to perform CVC placement using the simulator through an 'oblique in-plane' approach. Subjects randomized to group A will perform the procedure with the ultrasound monitor facing them, while subjects randomized to group B will perform the procedure with the ultrasound machine positioned at a 90° angle to their visual axis.

Eligibility Criteria:
Inclusion Criteria:

* 'Anesthesia and Intensive Care' and 'Emergency Medicine' residents
* Informed consent

Exclusion Criteria:

* None
Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure

The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure. The data from 2 clinics located in Germany and Spain participating in the "OPTICABG" as well as in the "PREMIVALVE" study will be used for assessment. Only patients receiving a complete or a partial sternotomy closed with Steelex® Sternum Set will be included in the analysis. "OPTICABG" patients were followed up 3 months after surgery and "PREMIVALVE" patients until 6 months after surgery. Adverse Events (AE) / Serious Adverse Events (SAE)(e.g. surgical site infection, sternum stability, stroke, myocardial infraction, death etc.) reported in both studies will be used for the STERCCAS analysis.


Eligibility Criteria:
Inclusion Criteria:

* OPTICABG study patients undergoing an elective, primary coronary artery bypass graft surgery (CABG) receiving a sternotomy, by whom the sternum was closed using Steelex® Sternum Set.
* PREMIVALVE study patients undergoing a cardiac valve replacement or reconstruction receiving a complete or partial sternotomy, by whom the sternum was closed using Steelex® Sternum Set.
* Eligible patients from the OPTICABG study and PREMIVALVE study who have provided their written informed consent
* Age ≥18 years

Exclusion Criteria:

* OPTICABG and PREMIVALVE patients receiving a sternotomy or partial sternotomy which was not closed with Steelex® Sternum Set.
Osteonecrosis of the Jaw (ONJ) Case Registry

Osteonecrosis of the Jaw (ONJ) Case Registry

The purpose of the ONJ case registry is to describe the natural history of positively-adjudicated ONJ in subjects with cancer with an observation period of 5 years. Most of these subjects are expected to have received bone antiresorptive agents such as bisphosphonates or denosumab together with cancer-specific therapies (eg, chemotherapy, steroids, or anti-angiogenics). It is also possible that the registry will include subjects with cancer who developed ONJ without exposure to any antiresorptive therapy.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years of age) with diagnosis of cancer
* Newly diagnosed, positively-adjudicated ONJ
* ECOG \<=2 and expected survival ≥3 months
* Willing to provide access to previous and future medical and dental information
* Subject or subject's legally acceptable representative has provided written informed consent

Exclusion Criteria:

* History of radiation to the jaws administered for the treatment of cancer
* Subject will not be available for protocol required study visits, to the best of the subject and investigator's knowledge.
* Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
Flash Glucose Monitoring Study for Diabetes

On the first of July 2016, the Freestyle Libre Flash Glucose Monitor (FGM) will be reimbursed in Belgium by means of a new diabetes reimbursement program for adults. For children, the Freestyle Libre FGM is also reimbursed by means of a new reimbursement program from the first of August 2016 onwards. Making this the only way to receive the device in Belgium. To understand the impact of this new FGM on diabetes patients in UZ Leuven, OLVZ Aalst, and UZ Antwerp, we want to study the use of the device by our patients by means of an observational study where patients complete questionnaires at regular time points in the first year of usage and after 24 months Clinical data will be gathered during the routine clinical visits as part of the reimbursement program.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* \>= 4 years
* Using flash glucose monitoring

Exclusion Criteria:

* Doesn't want to sign the informed consent
* \< 4 years
* Not using flash glucose monitoring
Perception and Multisensory Integration in Neurological Patients Using fMRI

The main objective of the study is to explore and map brain areas involved in sensory perception and multisensory integration in patients with central or peripheral neurological damage. The investigators hypothesize for example, that a change (compare to healthy subjects) in the perceptual maps and body representation could be detected and characterize in patients suffering from impairments of peripheral nerve conduction.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of the investigated neuronal disease

Exclusion Criteria:

* contraindication for MRI scan
* pregnancy
* refusal to participate in the study
Determining Feasibility and Acceptability of Sharing Video Recordings With Patients With ALS and Caregivers

Our objective in the proposed project is to: (a) operationalize and determine the feasibility and acceptability of a trial where clinic multi-disciplinary clinic (MDC) visits are audio/video recorded and shared with patients with ALS and their caregivers; (b) gather preliminary data examining the impact of routinely adding audio/video recordings of clinic visits to UC on self-management ability and other behavioral, health and health services outcomes at baseline (T0) and other regular interviews from enrollment (T1= 1 Week, T2= 3 Months); and (c) identify factors pertinent to the acceptability of our study protocol and the audio/video recording of visits.

We will conduct a single-site, two-arm, parallel group, patient-randomized, controlled, pilot trial with 3-month follow up, to determine the feasibility, acceptability, and potential effectiveness of sharing audio/video recordings of multidisciplinary ALS clinics with patients and their caregivers. We will recruit 24 patients with ALS and their caregivers over a recruitment period of 1 year. We are primarily interested in determining the feasibility of the trial and acceptability of the audio/video intervention. We will also explore the impact on the patients' ability to self-manage their care as well as exploratory outcomes, at baseline (T0 = pre-visit), at T1 (1 week), and at T2 (3 months).

Eligibility Criteria:
Inclusion Criteria:

* diagnosed and primarily treated for Amyotrophic Lateral Sclerosis (ALS)
* Aged 18 years or greater
* Can communicate in English (verbally, on a computer, or with assistance)
* Have email
* Have internet access
* Willing to have their multidisciplinary clinic visit audio/video recorded for a 3 month period

Exclusion Criteria:

* Those without the capacity to provide consent, either themselves or via proxy
Immunogenicity and Safety of an Acellular DPT Vaccine During Pregnancy

That is a double-blind randomized trial with parallel control to demonstrate the safety and immunogenicity of acellular Tdap vaccine in pregnant mexican women. The general objective is to determine the safety and immunogenicity of acellular Tdap vaccine.

The experimental group will receive acellular Tdap vaccine and the control group will receive a placebo consisting of saline 0.9% Sodium Chloride solution, randomly assigned, which will be administered by the same route (intramuscular) and at the same dose (0.5 ml) that the vaccine.

Type of Study: Clinical, randomized, double-blind, parallel control study. Study Subjects: Pregnant women of 19-38years of age, gestational age of 12-24 weeks, low risk of obstetric complications (according to the Obstetric Risk Assessment Form), normal anatomic ultrasound performed in the second quarter of pregnancy and residence in Guadalupe, and Juarez cities in Nuevo Leon State.

The experimental group will receive acellular Tdap vaccine and the control group will receive a placebo consisting of saline (0.9% Sodium Chloride) solution, randomly assigned, which will be administered by the same route (intramuscular) and at the same dose (0.5 ml) that the vaccine by trained personnel.

For both groups, 6 blood samples will be taken. Women: Before and at least 4 weeks after the vaccine or placebo were administered, at hospital admission for delivery. Infant: collected at delivery (cord), 2, 4 and 6 months of age.

Immunogenicity will be compared in both groups by measuring the increase of three of the following antigen-specific antibodies: Pertussis toxin (PT), pertactin (PRN),and fimbriae 2 FIM 2).

Safety Assessment: Each pregnant will be observed at 30 minutes, 24 and 48 hours and one month after the application of the vaccine for side effects.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 38 years
* Pregnancy between 22 and 32 weeks of gestation
* Covered by Ministry of Health medical security
* Definitive residency in Guadalupe and Benito Juarez cities
* Pregnancy termination in the study's hospital.
* At low risk for complication as determined by the obstetrical risk assessment form (ORAF)
* Second trimester or later ultrasound with no significant abnormalities
* Intend to be available for follow up visits and phone calls access through 6 months following delivery
* Willing to give written informed consent

Exclusion criteria:

* Serious mental illness. (Schizophrenia, psychosis, major depression).
* Serious underlying medical condition (e.g Degenerative diseases: Diabetes Mellitus,Hypertension and so on.
* Current smoking or use of drugs.
* Receipt of tetanus-diphtheria toxoid immunization within the past 2 years.
* Be considered as a high risk pregnancy for serious obstetrical complication according to the local Obstetrical Risk Assessment Form.
Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery

Current evidence regarding the efficacy and safety of perioperative administration of tranexamic acid for antifibrinolysis does not suffice to support its use in major spinal surgery.

OBJECTIVES: To evaluate the effectiveness of tranexamic acid for decreasing transfusion requirements and bleeding in this patient population. To evaluate the safety of this antifibrinolytic agent in the intraoperative and mid-term postoperative period.

METHODS: Multicenter, randomized, double-blind, placebo-controlled clinical trial with parallel groups. The main outcome measure is intraoperative and postoperative transfusion requirements; blood loss and safety will also be evaluated. Previous results in other types of surgery suggest that tranexamic acid reduces transfusion requirements and blood loss. Hence, the hypothesis of this study is that tranexamic acid will significantly reduce blood loss in comparison to a placebo in major spine surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old of both sexes
* scheduled for complex spine surgery
* ASA I-III
* weighing more than 30 kg
* body mass index \<30 kg/m2
* operated on in the participating hospitals
* major spinal surgery
* signed an informed consent form to be included in the study

Exclusion Criteria:

* a history of allergy or hypersensitivity to the agent used
* receiving medication that can interfere with coagulation (acetylsalicylic acid, oral anticoagulants, or antiplatelet agents)
* a history of frequent bleeding
* plasma creatinine values \>1.5 mg/dL in the baseline analysis
* platelet count less than 150,000/mm3 in the follow-up analysis
* abnormal prothrombin time (INR \>1.5) or partial thromboplastin time (INR \>1.5)
* a history of a thromboembolic episode before surgery
* family history of thromboembolism
* lack of consent to participate in the study
* infectious disease, tumor or trauma of the spine as the reason for surgery
* scheduled for surgery with an anterior and posterior surgical approach, whether sequential or on the same day
Evaluating the Pharmacokinetic Characteristics of AD-102 in Healthy Volunteers

The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-102 in healthy male subjects

This study is to evaluate the pharmacokinetic characteristics and safety of AD-102 compared with administration of raloxifen 60 mg + Cholecalciferol 800IU in healthy male subjects

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit
* The Age between 19 and 50 in healthy male volunteers at the time of screening visit

Exclusion Criteria:

* As a result of laboratory tests, the following figures: ALT or AST\> 2 times upper limit of normal range
* As a result of laboratory tests, the following figures: 25-OH vitamin D total \<9 ng/mL
Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy

To identify clinical, echocardiographic, and hemodynamic parameters which can predict persistent PH after PMC, and also to determine the impact of persistent PH on the clinical outcomes.

Pure mitral Stenosis develops in approximately 40% of all patients with rheumatic heart disease, and is frequently complicated by Pulmonary hypertension (PH). Pulmonary hypertension influences symptomatology and long-term prognosis. Percutaneous Mitral Commissurotomy (PMC), was first described in 1984, has good results and is performed by antegrade access to the mitral valve through trans-septal puncture by one of various techniques (e.g. Inuoe, and multitrack system). Pulmonary artery pressures (PAP) decrease following PMC. The improvement in pulmonary hypertension after PMC is explained by the improvement in the mitral valve area and subsequent decompression of left atrium (LA) and pulmonary venous beds. Even though there have been studies showing excellent results following PMC in all grades of PH, nonregression of PH following PMC is not uncommon. The component of PAP contributed by the passive transmission of the elevated LA pressure regresses immediately after a successful PMC proportional to the reduction in transmitral gradient. The PH contributed by pulmonary arteriolar constriction slowly comes down over weeks or a few months, But a "fixed" component due to pulmonary vascular disease usually persists.

Eligibility Criteria:
Inclusion Criteria:

* Severe mitral stenosis (mitral valve area ≤1.5cm).
* Significant dyspnea.
* Favorable anatomical characteristics for PMC as assessed by transthoracic echocardiography

Exclusion Criteria:

* Significant mitral regurgitation (≥ grade II/IV). Bilateral commissural calcification.
* Presence of other lesions which need open heart surgery.
* Wilkins' score \> 12.
* Persistent LA thrombus despite adequate anticoagulation.
* End stage renal or liver disease.
* Patients with severe COPD and other chest problems that might be complicated by pulmonary hypertension per se.
Ovary Syndrome for Efficient Diagnosis and Targeted Therapy

OBJECTIVES:

1. Analysis of DNA methyl transferases (DNMT1, DNMT3A and DNMT3B) and Histone deacetylases (HDAC 1,2,3 and SIRTs) polymorphisms (Somatic and germ line variations).
2. Analysis of differential mRNA and protein expression of epigenetic markers in ovarian tissues obtained from PCOS patients.
3. miRNA regulated epigenetic mechanisms in PCOS
4. Epigenetic regulation of endocrine genes in PCOS

DESIGN : A Case Control study.Sample size:200

1. We will take both blood and ovarian tissue samples used to diagnosis.
2. We will take approximately 3 ml of blood which will be used from the blood sample collected for routine preoperative tests (surgical profile) before their planned surgery or for disease evaluation.
3. Small tissue samples (from ovary) will be taken from the tissue which is surgically excised as a part of treatment.

Eligibility Criteria:
Inclusion Criteria:

* All the subjects would be of Indian origin (controls \~100, cases \~100). They would be in their reproductive age (18-45 yrs). Rotterdam consensus would be used to diagnose PCOS and cases will be selected based on it.

Criteria for the diagnosis of PCOS would include oligo-ovulation cycles longer than 35 days or less than 26 days, elevated free testosterone levels (0.5 ng/dl; the cutof level for free testosterone level was the mean±2 SD according to normal levels in controls), oligomenorrhea or amenorrhea.

A Ferriman-Gallwey (FG) score of≥7 would be taken as indicator for the presence of hirsutism. In accordance with the above criteria, polycystic ovary morphology would be determined by transvaginal ultrasonography, which defines PCOS as the presence of 12 or more small (2-9 mm) follicles in each ovary.

Control subjects would have no signs of menstrual dysfunction and their androgen levels should be within the normal range, with normal glucose tolerance, and no family history of hirsutism, type 2 diabetes mellitus, and infertility.

Exclusion Criteria:

* Women with other causes of hyperandrogenism such as hyperprolactinemia, androgen-secreting tumors, Cushing syndrome and nonclassic congenital hyperplasia would be excluded from this study.
Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci

This is a research study designed to look at the efficacy and safety of daptomycin given at a dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections caused by Staphylococci. These types of bacteria are among the most common types of bacteria causing infections of prosthetic joints.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be between the ages of 18 and 80, inclusive
* Subject must have a diagnosis of prosthetic joint infection (PJI) in a hip or knee joint which has never previously been totally revised because of an infection and for which they are anticipated to undergo a two-stage replacement surgery
* Subject must have a positive microbiological identifier of staphylococci.
* If Subject is female of childbearing potential, must be willing to practice reliable birth control

Exclusion Criteria:

* Subject has permanent intravascular prosthetic material such as heart valves or pacemakers
* Subject has a creatinine clearance (CLCR) \<30 mL/min as determined by the Cockcroft-Gault equation using actual body weight.
* Subject has significant hepatic dysfunction
* Subject has a fungal or mycobacterial PJI
* Subject is known to be HIV-infected with CD4 count ≤ 200 cells/ mm3
* Subject has an abnormal creatine phosphokinase (CPK) (elevated CPK level ≥ 2x ULN) at baseline as measured by central laboratory
* Subject is currently under treatment with chemotherapeutic agents excluding chronic maintenance therapy (e.g. tamoxifen to prevent relapse of primary breast cancer)
* Subject is pregnant, nursing, or lactating.
* Subject is receiving or is expected to receive chronic immunosuppressive therapy during the study.