cyrilzakka/clinical-trials huggingface dataset:
Promote Access to Stop Suicide: Comparison of Follow up Services for Youth at Risk for Suicide

This research study is designed to answer specific questions about new ways to provide services for youth at-risk of suicide.

The proposed project will be able to provide services to high-risk youth in Ohio. This randomized controlled trial for youth discharged from inpatient psychiatric hospital will be able to determine what combination of services is best suited to reduce subsequent suicide attempts and re-hospitalization.

All youth (ages 10-18), that fit the inclusion criteria, will be recruited from the inpatient unit at Fairview Youth Inpatient Unit. Patients will be consented, enrolled, and assigned to group by the Research Coordinator working at the unit. The Methodologist/ Statistician will generate a random allocation sequence using random number generator and communicate group assignment to the Research Coordinator. There will not be any restriction on randomization. The PI will be blinded to all group assignments.

The clinical research tools and screens that will be administered in this study include: Columbia-Suicide Severity Rating Scale (C-SSRS), The Suicidal Ideation Questionnaire (SIQ), The Adverse Childhood Experiences (ACEs), Ohio Scales, Children's Global Assessment Scale (CGAS), Clinical Global Impressions (CGI-I).

The participants of the study will be seen by the child psychiatrist (Dr. Varkula) and the research coordinator at the initial appointment, and a 6 month follow-up (Dr. Falcone). The C-SSRS and the SIQ will be administered at the initial appointment and the follow-up appointment. The study's research coordinator will be regulating the 3 month phone call and scheduling the 6 month up visit and administering the Ohio Scales questionnaire with the parents and/ or guardians of the child. There will also be a 12 month follow-up phone call conducted by the research coordinator. During this time, the information for the C-SSRS questionnaire, the SIQ, the Ohio Scales (for both the parent and the child), the CGI-I, and the CGAS will be administered.

Eligibility Criteria:
Inclusion Criteria:

* All patients (ages 10-18 years) admitted to the Cleveland Clinic Inpatient Child and Adolescent psychiatry unit after a suicide ideation, behavior, or attempt.
* This can be defined by any intentional, nonfatal self-injury, regardless of medical lethality, will be consider a suicide attempt if intent to die was indicated.
* Signed consent by the adult patient (18 years) or by a first-degree relative or a guardian (for children) at the time of enrollment in the study, and assent by the children as soon as is feasible.

Exclusion Criteria:

* Patients with a known history of autistic spectrum disorder, non-verbal patients and moderate or severe mental retardation (IQ less than 70 and those patients in special education full time), patients with substance dependency and patients with schizophrenia.
* Patients who are enrolled in case management will also be excluded from the study.
Evaluation of the Effect of a Shiitake Extract on Lipid Profile in Subjects With Moderate Hyperlipidemia

Effect of a dietary supplement with Shiitake extracts (Lentinula edodes) on lipid profile and other cardiovascular risk factors in subjects with moderate hyperlipidemia without pharmacological treatment.

Prospective, parallel, randomized and double-blind clinical-nutritional study of 8 weeks of duration and 2 study groups (1) Food supplement with extracts of the fungus Shiitake; 2) Placebo supplement with maltodextrin) to evaluate the effect of a food supplement derived from the Shiitake mushroom (Lentinula edodes) on the lipid profile, other cardiovascular risk factors and the intestinal microbiota in subjects with hyperlipidemia moderate without pharmacological treatment.

Eligibility Criteria:
Inclusion Criteria:

* Men and women from 18 to 65 years old.
* BMI ≥18.5 and \<30 kg/m2.
* Adequate cultural level and understanding for the clinical trial.
* Signed informed consent.
* Cardiovascular risk \<10% to 10 years measured by REGICOR.
* Total cholesterol ≥ 200 mg/d and at least 2 factors included in the following list:

  * ≥ 45 years or women ≥ 55 years.
  * Family history of cardiovascular disease (CVD) in first degree male relative less than 55 years of age and less than 65 years in women.
  * HDL cholesterol: men \<40 or women \<50.
  * Triglycerides ≥ 150mg/dL and \<200 mg/dL
  * LDL cholesterol ≥ 130mg/dL and \< 160mg/dL
  * Smoker
* Willingness to follow a healthy diet, hyperlipidemic control diet and a diet without stanols, sterols and yeast.
* Social or familiar environment that prevents from accomplishing the dietary treatment

Exclusion Criteria:

* Individuals diagnosed with Diabetes Mellitus type 1.
* Individuals diagnosed with Diabetes Mellitus type 2 on pharmacological treatment (unless it is possible the suspension 30 days before the trials).
* Individuals with dyslipidemia on pharmacological treatment;
* Individuals with hypertension on pharmacological treatment;
* Individuals \> 60 years smokers with total cholesterol \> 200mg/dL or LDL \>130mg/dl.
* Individuals with hypertension on pharmacological treatment uncontrolled.
* Individuals with hyperthyroidism and hypothyroidism on pharmacological treatment uncontrolled.
* Individuals allergic to Shiitake (Lentinula edodes)
* Individuals with chronic diseases (hepatic, kidney, ...)
* Individuals receiving at least the preceding 2 months a pharmacological treatment that modifies the lipid profile (for example, statins, fibrates, diuretics, corticosteroids, ADOs);
* Individuals who have participated in the last 6 months in a program or clinical trial to lose weight.
* Smokers wanting to stop to smoke during the period that clinical trial lasts.
* Individuals with mental illness.
* Consume drugs to lose weight during 30 days before starting the study
* Pregnant or breastfeeding women.
Optimizing the Technique of Embryo Transfer in IVF Using Better Imaging Guidance

This trial seeks to improve ultrasound imaging during embryo transfer in IVF by using a small, high resolution ultrasound probe used routinely for cardiac imaging in children.

Since the first pregnancy using IVF was achieved nearly 40 years ago, many aspects of this procedure have undergone significant progress. In contrast, the technique of embryo transfer (ET) has remained relatively unchanged. A simple yet critical element in the final step of IVF, ET has received little attention. In general, the procedure starts by placing a speculum in the vagina to visualize the cervix, which is cleansed with saline solution or culture media. A transfer catheter is loaded with the embryos is inserted through the cervical canal and advanced into the uterine cavity where the embryos are deposited.

The catheter is then withdrawn and handed to the embryologist, who inspects it for retained embryos. Ultrasound (US) guidance is used to facilitate atraumatic insertion of the catheter, as well as ensure correct location in the uterine cavity.

The available evidence suggests that there is a benefit of using US guidance during ET (Teixeira et al, Ultrasound Obstet Gynecol. 201;45:139-48, Abou-Setta et al, Fertil Steril. 2007;88:333-41).

High quality US imaging is difficult to achieve if the distance from the abdominal wall to the uterus is big (thick abdominal wall, retro-verted uterus), or if the bladder is not full enough.

High resolution US imaging dictates short distance between the US transducer and the organ of interest (in our case cervical canal and endometrium). Previous effort in that direction was done using a vaginal US probe. However, this instrumentation makes the ET technique cumbersome and difficult to perform. We hypothesize that a significant advantage in imaging quality can be achieved by placing a flat or concave high frequency US transducer in the posterior fornix as an extension of the posterior speculum blade.

Our overarching goal is to develop new ET procedure; this procedure will be dependent on precise and high resolution imaging. For that goal we consulted with ultrasound experts that recommended the use of dedicated probe. After a thorough review we found a probe (Philips 21381A / T6207) that is used for pediatric transesophageal applications with operating frequency of 4-7 Megahetz.

As part of the embryo transfer, the investigators plan to insert the above probe into the posterior fornix. The investigators will then evaluate the visualization abilities of placing a probe closer to the uterus. The aim is to define the ultrasound image parameters for ET. The information will be used to define the technical specification for a "tailor made" ET probe.

Eligibility Criteria:
Inclusion Criteria: IVF patients before embryo transfer. -

Exclusion Criteria: IVF patients not willing to participate

-
Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma

Emerging from a differential proteomic study of sample pairs of prostate cancer and benign tissue, annexin A3 (ANXA3) was chosen as a potential novel biomarker for the early and non-invasive diagnosis of prostate cancer. We wanted to show or investigate, that:

* ANXA3 can be detected in urine after standard digital rectal examination.
* ANXA3 has better specificities than tPSA, in particular in the grey zone of PSA
* ANXA3 can help avoid unnecessary biopsies
* ANXA3 can in the long run replace PSA as a marker

The aim of this multi centre and double-blinded study was to investigate specificities and sensitivities of early detection of prostate cancer with a new protein biomarker, annexin A3, using urine after digital rectal examination/massage (exprimate urine) in direct comparison to the corresponding measurements of the gold standard, total PSA. The material obtained by this non-invasive procedure was moreover used to determine appropriate cut-off values and optimal fractions (e.g. after centrifugation) and calibrations for quantitative measurements of this novel marker.

Patients (500-750) were (and are) continuously recruited from four clinical centres in Germany (Berlin, Tübingen, Ludwigshafen) and Austria (Innsbruck). The major aspect was:

• Can annexin A3 provide a better specificity than tPSA, in particular in the grey zone of PSA (2-10 ng/ml) and can annexin A3 thus contribute to a significant reduction of invasive transrectal biopsies?

Eligibility Criteria:
Inclusion Criteria:

* Patients with a histological confirmation of adenocarcinoma of the prostate
* Patients with benign prostatic hyperplasia (confirmed by histology of lance biopsies or TUR-P)

Exclusion Criteria:

* Patients with rectal extirpation
* Patients with renal or bladder tumors
Motivation's Effect on Home Exercise in Children With OBPP

The present study examined the effect of motivation on home exercise program and children's functional scores. 33 OBPP children (Narakas Type 2) aged between 0-18 months were divided into two groups. Intervention group was motivated via phone. Both groups were informed about OBPP, performed home exercises and filled exercise diary. Intrinsic Motivation Scale was used for measuring motivation and Gilbert and Raimondi Scoring and Active Movement Scoring were used for evaluating functional improvements at first assessment, 6th week and 12th week. For final comparison, parents were divided into two more groups (highly motivated and motivated group) based on motivation scores.

Home exercise program is widely used for treatment of OBPP children. The present study examined the effect of motivation on home exercise program and children's functional scores. 33 OBPP children (Narakas Type 2) aged between 0-18 months were divided into two groups. Intervention group was motivated via phone. Both groups were informed about OBPP, performed home exercises and filled exercise diary. Intrinsic Motivation Scale was used for measuring motivation and Gilbert and Raimondi Scoring and Active Movement Scoring were used for evaluating functional improvements at first assessment, 6th week and 12th week. For final comparison, parents were divided into two more groups (highly motivated and motivated group) based on motivation scores.

Eligibility Criteria:
Inclusion Criteria:

* Being classified as Narakas type 2a or 2b
* Being aged between 0 - 18 months
* Not having regular physiotherapy and rehabilitation program

Exclusion Criteria:

* Having a clinical condition such as upper motor neuron lesion that may affect child's affected arm or whole body,
* Having secondary surgery for orthopedic problems within last 6 months.
* Mother having an unidentified cognitive problem,
* Parents having another child with a disability,
* Parents not willing to participate.
Impact of Applying a Bandage Skin Hydrogel on the Pains of the Head and Neck in Patients With Cancer of Head and Neck Treated With Radiotherapy

The investigators hope to get by reduced and delayed acute radiodermatitis following the application of dressings to skin hydrogel Hydrosorb®, a reduction in head and neck pains and improved quality of life of patients with head and neck cancer treated with concomitant radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years old
* Carcinoma oral cavity, pharyngolaryngeal or without lymphadenopathy door
* Patient treated by one of the following diagrams

  * radiotherapy alone
  * postoperative radiotherapy + / - sensitized platinum (cisplatin or carboplatin)
  * ar chemoradiation 5-FU and platinum (the Cetuximab is not allowed)
  * diagram organ preservation (induction chemotherapy and radiotherapy in responders)
* Untreated patients
* Patient should receive conventional radiotherapy or tomotherapy
* Adapted stomatological care
* Life expectancy \> 3 months
* WHO score \< 2
* Patient stable, not having the time of the examination of evidence of recurrent or progressive malignancy other
* - For patients with an indication of chemotherapy combined with radiotherapy,biological assessments compatible with chemotherapy:

  * WBC \> 3000/mm3, Polynuclear \> 2000/mm3,Platelets \> 150,000/mm3, Creatinine less than 2 times normal; Bilirubin less than 2.5 times normal
* Patient fluent in French
* Affiliation to a system of social security
* Patient has given written consent

Exclusion Criteria:

* Patient with a history of malignancy, outside a basal cell carcinoma or cervical cancer treated and cured
* Patient has at the time of examination signs of recurrence or other neoplasia scalable
* Patient with a history of prior chemotherapy or radiation therapy with the exception of the scheme of organ preservation (induction chemotherapy before radiation)
* For patients with an indication of chemotherapy combined with radiotherapy, contraindication to treatment with specific platinum (cisplatin or carboplatin) with or without 5 Fluorouracil
* Infectious diseases uncontrolled
* Patient is pregnant or lactating or absence of contraception during their reproductive
* Patient hypertensive unbalanced under antihypertensive treatment
* Uncontrolled cardiac disease
* Patients with renal or hepatic
* Known allergy to any component of Ialuset ®
* Patient deprived of liberty under guardianship
* Any medical condition or psychological associate that could compromise the patient's ability to participate in the study
* Inability to undergo medical test for geographical, social or psychological
PAF-HEFT (Permanent Atrial Fibrillation in Heart Failure Trial)

Examination of CRT efficacy in patients with progressive heart failure and atrial fibrillation at the same time


Eligibility Criteria:
Inclusion Criteria:

* LVEF \<35%
* QRS time ≥150ms LBB
* NYHA classification ≥ NYHA III
* permanent (\> 6 months) Atrial Fibrillation
* sinus rhythm (control group)
* Condition after Implantation of a Medtronic CRT device
* written informed consent

Exclusion Criteria:

* exchange of the current CRT device
* mitral incompetence (2. degree)
* no compliance
* participation in another study
* pregnancy
* patients with AV node
* patients after heart transplant or those who are on the transplant list
Escin in Patients With Covid-19 Infection

In December 2019,a new type of pneumonia caused by the coronavirus (COVID-2019) broke out in Wuhan ,China, and spreads quickly to other Chinese cities and 28 countries. More than 70000 people were infected and over 2000 people died all over the world. There is no specific drug treatment for this disease. Considering that lung damage is related to both viral infection and burst of cytokines, our idea is to evaluate the efficacy and safety of escin as add-on treatment to conventional antiviral drugs in COVID-19 infected patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 75 years, extremes included, male or female
* Positivity to covid-19 screening test in molecular biology
* In escin group: Low response to standard treatment
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Female subjects who are pregnant or breastfeeding.
* patients with previous history to allergy
* patients meet the contraindications of escin
* Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.
* patients can't take drugs orally
Evaluation of HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2BREASTDX

To prospectively evaluate the impact of HER2DX on the decision-making processes of the treating physicians and especially among the routine multidisciplinary tumour board, in defining type and setting of systemic therapy administration in patients with stage I-III HER2+ BC, and the degree of clinician's confidence in the treatment recommendation.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age;
* Histologically confirmed HER2+ breast cancer;
* Stage I-III breast cancer without evidence of distant metastases;
* Being candidate to neoadjuvant/adjuvant therapy and locoregional treatment (surgery +/- radiotherapy);
* Written informed consent, signed by the patient, to study-specific procedures (the consent will consist of 2 levels: level 1 specifically for patients enrolled in the primary endpoint cohort and level 2 for all patients);

Exclusion Criteria:

* HER2- BC;
* Stage IV breast cancer;
* Lack of informed consent because of patient's incapable of discernment or unwilling to participate;
Evaluation of the Balance, Muscular Electric Activity, Proprioception Before and After in the Vibratory Platform

Introduction: Proprioception refers to the information's dynamic, sent to central nervous system by the free nerve endings and mechanoreceptors, about the biomechanics relationship for the joint tissue. The proprioceptive exercises show a big prophylactic action by musculoskeletal injuries. Among the top modalities of these exercises, it can be cited the Whole Body Vibration (WBV). Objectives: The objective of this study was to evaluate and compare the joint position sense, muscle electric activity and the postural sway in healthy individuals, before and after performing proprioceptive exercises on the vibrational platform or on a stable surface. Materials and Methods: 20 healthy young (24,85 + 4,27 years) were recruited, randomly divided into two groups, Control Group (GC) and Experimental Group (GE). Were realized evaluates of the proprioception by means of the joint position sense, the muscle electric activity of peroneus longus, gastrocnemius medialis, vastus medialis and gluteus medium, and the postural sway by means of the postural sway before and after one assistance consisting of 4 sets of 60s with unipodal standing position on soil (GC) or on vibrational platform (GE).

The individuals who composed the two groups performed the same exercise protocol, however, on different surfaces:

* Control group: stable surface.
* Experimental group - vibratory platform, make / model Nissan Fisio; orbital amplitude: 6 mm; frequency: 30 Hz The exercises consisted of unipodal support on the non-dominant lower limb with the contralateral limb in a knee flexion near 90º. This exercise is a proprioceptive test that requires more than all joints and musculature of the lower limb, and is widely used in studies, for providing obvious clinical signs in the presence of dysfunctions.

Activities were performed with the individual standing without using any type of footwear, remaining without support of the hands and with the upper limbs abducted to 90º with the fixed eye on the horizon line. Both groups performed 4 sets of 60s of sustained posture. In the intervals between the series there was the rest of 60s, remaining in orthostasis with support of the upper limbs.

Eligibility Criteria:
Inclusion Criteria:

* Individuals from 18 to 30 years;
* Healthy;
* Sedentary;
* That they agree with the Free and Informed Consent Term.

Exclusion Criteria:

* Recent surgery;
* Open wounds;
* Contagious skin diseases;
* Glaucoma;
* Labyrinthitis;
* Uncontrolled heart diseases;
* Pacemaker;
* Lower limb injuries;
* Neurological dysfunctions;
* Pain in the lower limbs;
* Use of drugs that alter the balance;
* Alcohol consumption in the previous 24 hours.
Role of Cerebral Oximetry in Reducing Postoperative Morbidity Following Cardiac Surgery

Cerebral oximetry employing near-infrared spectroscopy (NIRS) is a non-invasive modality used to estimate regional cerebral oxygen content saturation (rSO2). Near-infrared spectroscopy has increasingly been used in perioperative setting of heart surgery and many studies have outlined an increased incidence of postoperative morbidity in patients with significant perioperative reductions in rSO2. Although a relationship between rSO2 reductions and adverse outcomes has been reported, there is not compelling evidence that interventions to correct rSO2 during cardiac surgery lead to improved clinical outcomes.

Hypothesis of the study is that interventions to normalize intraoperatively decreased cerebral rSO2 would reduce the overall incidence of postoperative complications in high-risk cardiac surgery patients.


Eligibility Criteria:
Inclusion Criteria:

High-risk cardiac surgery patients as determined by at least one of the followings:

* the age greater than or equal to 75 years on the day of screening;
* left ventricle ejection fraction less than 35%;
* use of a preoperative intraaortic balloon pump;
* combined valve and coronary artery surgery or multiple valve surgery in patients who have congestive heart failure, or renal insufficiency (creatinine clearance \< 60 ml/min)

Exclusion Criteria:

* refusal of consent