cyrilzakka/clinical-trials huggingface dataset:
Establishing Efficacy of an Inpatient Intervention and Phone App to Reduce Suicidal Risk

In this 2-site study, University of Texas Southwestern Medical Center (UTSW) and Western Psychiatric Institute and Clinic (WPIC), the investigators will conduct a randomized clinical trial (RCT) in 240 psychiatrically hospitalized suicidal adolescents, examining the single and additive effects of two components of an inpatient unit intervention for suicidal adolescents, As Safe As Possible (ASAP), which focuses on emotion regulation and safety planning, and an emotion regulation/safety plan phone app (BRITE).

The investigators aim to randomize 240 adolescents psychiatrically hospitalized for suicidal ideation with a plan or a suicide attempt to one of four treatment arms: (1) ASAP + BRITE + TAU (treatment as usual); (2) BRITE + TAU (treatment as usual); (3) ASAP + TAU (treatment as usual); and (4) TAU (treatment as usual) alone. The investigators will assess suicidal ideation and behavior at 4, 12, and 24 weeks post-intake, in order to:

1. Assess the relative efficacy of ASAP, BRITE and the combination on suicidal ideation, non-suicidal self-injury (NSSI), and suicide attempts, and re-hospitalizations.
2. Examine mediators and moderators of treatment outcome.
3. Examine the costs and cost efficacy of ASAP and BRITE and the combination.

Eligibility Criteria:
Inclusion Criteria:

* Youth admitted to the inpatient unit at either site for a recent suicide attempt or significant suicidal ideation with a plan or intent.
* The youth and parent are able to complete assessments in English, and the youth is able to complete therapy.

Exclusion Criteria:

* The youth currently exhibits psychosis.
* The youth currently exhibits mania.
* The youth is currently \<85% of their ideal body weight.
* The youth is intellectually incapable of completing the study, e.g. has an intelligence quotient (IQ) \< 70.
Correlation Between the Interstitial and Arterial Glucose in Post Surgery Patients

The EU funded project CLINICIP (Closed Loop Insulin Infusion for Critically Ill Patients) aims to develop a low-risk monitoring and control device which allows maintaining metabolic control in intensive care units. A system will be developed comprising three subsystems: a body interface for the delivery of biofluids, biosensors for the determination of glucose concentration in these biofluids and an adaptive control algorithm that generates advice and thus represents a decision support system with respect to insulin infusion rate to establish glycaemic control in critically ill patients. Within a closed loop system, intensified insulin treatment will make use of the calculations leading to external regulation of glucose.

It is the aim of this study to evaluate the correlation between arterial blood glucose concentrations and interstitial fluid glucose concentrations in post surgery patients in the Intensive Care Unit (ICU). Interstitial fluid glucose concentrations are based on microdialysis in subcutaneous adipose tissue and calculated using the ionic reference technique.

This trial includes a screening visit (V1) and a monitoring visit (V2) and follow-up assessment. Visit 1 will be performed before performance of surgery to obtain informed consent and to assess patient eligibility. At Visit 2 monitoring visit after surgery) arterial blood glucose values will be monitored and subcutaneous sampling of ISF with microdialysis for glucose determination will be performed. Visit 2 will last from admittance to the ICU for 48 hours. In a follow-up assessment, two weeks after the end of visit 2, further clinical relevant data for the two week period after visit 2 will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained before any trial-related activities.
* Planned surgery and post-surgery stay in the ICU.
* Study day inclusion criteria: Increased blood glucose levels at admission to the ICU ( \> 120 mg/dL; \> 6.7 mM)
* Age of patients in the range from 18 to 90 years.

Exclusion Criteria:

* Known or suspected allergy against insulins.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
* Any disease or condition which the Investigator or the treating physician feels would interfere with the trial or the safety of the patient.
Low-dose Bevacizumab With HSRT vs BVZ Alone for GBM at First Recurrence

This randomized phase II trial studies how well lose dose bevacizumab with Hypofractionated Stereotactic Radiotherapy (HSRT) works versus bevacizumab alone in treating patients with glioblastoma at first recurrence. The primary endpoint is 6-month progress-free survivaloverall survival after the treatment. Secondary endpoints included overall survival, objective response rate, cognitive function, quality of life and toxicity.

To establish an improvement in 6-month pfs in recurrent glioblastoma patients receiving low-dose bevacizumab and re-irradiation compared with patients receiving bevacizumab alone.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years of age;
* Karnofsky performance status (KPS) ≥ 60;
* Original histopathologically proven diagnosis World Health Organization (WHO) Grade 3/4 glioma;
* Underwent surgery, chemoradiotherapy and adjuvant chemotherapy (Stupp Protocol) after initial diagnosis, recurrent based on the Response Assessment in Neuro-Oncology (RANO) criteria and/or histopathologically proven;
* Measurable disease;
* Estimated survival of at least 3 months, maximal diameter on T1+C MRI ≤ 3.5 cm;
* Hgb \> 9 gm; absolute neutrophil count (ANC) \> 1500/μl; platelets \> 100,000; Creatinine \< 1.5 times the upper limit of laboratory normal value; Bilirubin \< 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) \< 3 times the upper limit of laboratory normal value;
* Signed informed consent form;
* Agreed to participate the follow-up.

Exclusion Criteria:

* Prior invasive malignancy unless disease free;
* Received re-irradiation;
* More than 3 relapses or evidence of subtentorial recurrent disease or tumor greater than 6 cm in maximum diameter;
* Prior therapy with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR;
* Pregnancy or or nursing mothers;
* Participated in other trials after diagnosis of recurrent;
* Influence factors toward oral medications;
* Patients with CTCAE5.0 grade 3+ bleeding;
* Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms); according to NYHA criteria, grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) \<50%;
* Long-term unhealed wounds or fractures;
* History of organ transplantation;
* Serious diseases that endanger patients' safety or affect patients' completion of research,according to the researchers' judgment.
Virtual Acoustic Localization Experiment

The present study has the evaluation of a test to measure the localization performance goal . It is about the perception of danger audio signals in everyday listening environments nearby which are reproduced in controlled laboratory conditions. In addition, a dereverberation algorithm regarding speech intelligibility and localization ability is evaluated . The research hypothesis is that the dereverberation of the audio signals can improve speech intelligibility for both normal hearing and hearing-impaired persons. In addition, the binaural dereverberation algorithm should not affect the localization ability in everyday situations.


Eligibility Criteria:
Inclusion Criteria:

* adults , in general healthy (no diagnosis of dementia and/or stroke known), mother tongue: (swiss) german, normal hearing or with hearing aid wearers both sides or with CI support on both sides, symmetrical hearing loss

Exclusion Criteria:

* deviation of inclusion criteria, known fluctuating, rapidly progressive hearing loss, test person is not able to come one time a week to the University Hospital of Zurich or to handle 1-2 hours appointments or is not able to use touchscreen
Effectiveness of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-136)

This trial will compare the effectiveness of one dose of ciclesonide against one dose of budesonide in patients with asthma.

The aim of the present trial is to compare the efficacy of ciclesonide versus budesonide on pulmonary function, symptoms and use of rescue medication in patients with asthma. The onset of action and the safety and tolerability of ciclesonide in comparison to budesonide will also be investigated.


Eligibility Criteria:
Main Inclusion Criteria:

* During the last 4 weeks prior to baseline, treatment with an inhaled steroid (dosage: up to 250 mcg fluticasone propionate or equivalent)
* FEV1 80 - 105% of predicted
* Healthy with the exception of asthma
* Written informed consent has been obtained
* Outpatients
* Patients who have a history of persistent bronchial asthma for at least 6 months

Main Exclusion Criteria:

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* Concomitant COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
* An asthma exacerbation or an infection of the lower airways prior to entry into the baseline period
* Pregnancy
* Intention to become pregnant during the course of the study
* Breast feeding
* Lack of safe contraception
* Patient is current smoker with 10 or more pack-years
* Patient is ex-smoker with 10 or more pack-years
Local Pharmacokinetics and Tolerability of Bimatoprost Applied to the Scalp of Male Patients With Androgenetic Alopecia

This study will evaluate the skin pharmacokinetics and tolerability of bimatoprost Formulation A and Formulation B following 14 days of once daily topical administration in male participants with androgenetic alopecia (AGA).

Single-center, multiple-dose study evaluting the local pharmacokinetics and tolerability of bimatoprost following 14 days of once daily topical administration of bimatoprost Formulation A and Formulation B (both containing 1% bimatoprost) to the scalp of male patients With androgenetic alopecia

Eligibility Criteria:
Inclusion Criteria:

-Patients with mild to moderate Androgenetic Alopecia of the vertex area of the scalp.

Exclusion Criteria:

* Patients with uncontrolled systemic disease
* History of significant cardiovascular disease
* Scarring disease, infection, or abnormality of the scalp or hair shaft or systemic disease that could cause temporary hair loss (eg, seborrheic dermatitis, psoriatic dermatitis, alopecia areata, cicatricial alopecia, uncontrolled hyperthyroidism/hypothyroidism, tinea infections, and genetic disorders)
* Patients who have received hair transplants or have had scalp reductions
* Abnormal bone biomarker laboratory results.
Brain Health Together: Development and Pilot Test

The objectives of this study were to develop and pilot-test Brain Health Together (BHT), a 12-week, virtual-group program that combines our evidence-based, mind-body, group movement program with brain health education and coaching to reduce dementia risk through targeting modifiable risk factors among older adults with cognitive impairment.

Our study design for developing, pilot-testing, and refining the BHT program was conducted in 2 phases. In Phase 1, the investigators used a human-centered design approach to deeply understand and respond to the needs, challenges, and motivations of potential users when developing the BHT program. In Phase 2, the investigators performed a pilot study to refine BHT program content and assess acceptability and potential feasibility.

Eligibility Criteria:
Inclusion Criteria:

* Mild cognitive impairment or subjective cognitive decline
* English language proficiency
* Active participants in Moving Together (Intervention Arm)

Exclusion Criteria:

* wheelchair user
* medical condition, physical limitation, visual or hearing impairment or psychiatric condition that could affect ability to participate in a virtually-delivered multicomponent intervention
* moderate/severe dementia severity
Evaluation of the Fast Fill Technique for Anal Acoustic Reflectometry (AAR) in the Incontinent Anal Sphincter

Anal Acoustic Reflectometry (AAR) is a technique that has been studied in our department over the last 6 years. Sound waves pass into a balloon placed in the anal canal and are used to measure the cross-sectional area. By gradually increasing and decreasing the pressure in the balloon the investigators can measure the pressure at which the cross-sectional area starts to increase and decrease, and the anal canal starts to open and close. This assessment mimics the natural opening and closing of the anal canal and the effect of squeezing the muscles.

The gold standard investigation of the anal sphincter muscles has been manometry which measures anal canal pressure at rest and during squeeze. However, it has limitations. Despite the two measurements being within the normal range, some patients can have significant faecal incontinence. This has prompted clinicians to search for a better investigation to guide the management of this condition.

AAR is a reproducible and repeatable technique that has been used as a research technique in the assessment of faecal incontinence. It has been shown to correlate with symptom severity and, unlike manometry, is able to distinguish between different symptomatic subgroups with faceal incontinence. In our studies so far the investigators have increased the bag inflation pressure a step at a time which means that each study takes about 20 minutes to perform. The limitation of this method is that during the measurement of squeeze pressure the sphincter muscle is subject to fatigue. A recent study using the acoustic technique in the urethra has demonstrated a faster method of recording measurements over an 8 minute period. The investigators propose to study the fatiguability effects of this faster technique and validate the method against the existing step-wise technique and standard anal manometry.

Patients will be randomised into two groups:

1. Stepwise then fast-fill
2. Fast-fill then stepwise


Eligibility Criteria:
Inclusion Criteria:

* adults over 18 years
* have capacity to consent to the study
* patients with symptoms of faecal incontinence

Exclusion Criteria:

* minors under age of 18 years old
* patients who lack capacity to consent
Ivabradine to Prevent Anthracycline-induced Cardiotoxicity

Anthracyclines are associated with cardiotoxic effects. Previous studies suggest that enalapril, and or carvedilol, protect against cardiovascular effects of these drugs.

Ivabradine selectively reduces heart rate through inhibition of the cardiac pace maker IF channel, thus prolonging the duration of spontaneous depolarization in the sinus node. Additionally, ivabradine might preserve myocardial perfusion without negative inotropic effect and probably maintain cardiac contractility despite the reduction of heart rate.

Ivabradine has been shown to improve outcome in patients with heart failure and angina. The aim of this study is to evaluate whether ivabradine might prevent anthracycline-induced cardiotoxicity.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-year-old or older;
* Cancer diagnosis;
* Chemotherapy with anthracycline;
* Written informed consent

Exclusion Criteria:

* Chronic Kidney Disease (Creatinine clearance inferior to 30mL/min/1.73m2)
* Bradycardia (heart rate less than 60 beats per minute)
* Atrial fibrilation;
* Previous diagnosis of heart failure;
* Pregnancy;
* History of previous hypersensibility to the study drug;
* Participating in another study protocol.
Perioperative Melatonin in Lumbar Laminectomy

Patients undergoing lumbar laminectomy surgery will receive either 5 or 10 mg melatonin or placebo once the evening before surgery and again 90 minutes before surgery. Pain and anxiety will be assessed over the 24 hour period following surgery.


Eligibility Criteria:
Inclusion Criteria:

* age 18 to 65 years old
* ASA status 1-3
* having lumbar laminectomy 2 to 3 levels with or without fusion

Exclusion Criteria:

* receiving emergent procedure
* surgery for neoplastic spine lesion
* allergy to melatonin or its non-medicinal ingredients
* allergy or contraindication
* BMI over 35 or or less than 20 kg/m2
* pregnancy or breastfeeding
* failure to provide informed consent
IVUS CHIP UPP Registry

The IVUS CHIP UPP Registry is a prospective, observational, multicenter, single-arm registry. A total of 1010 patients with complex coronary lesions will be enrolled in up to 2 years, with at least 500 men and women. All patients will be treated with IVUS-guided PCI.

Objective is to describe in a United States population the clinical efficacy and safety of an IVUS-guided approach in patients who self-identify within a census-defined minority undergoing PCI of complex coronary lesions, as well as clinical outcomes up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. The patient must be ≥18 years of age and self-identify within a US census-defined minority
2. Patients with an indication for PCI of at least one lesion satisfying any of the following criteria:

   1. Angiographic heavy calcification
   2. Ostial lesions
   3. True bifurcation lesions involving side-branches \&amp;gt;2.5mm
   4. Left main lesions
   5. Chronic total occlusion
   6. In-stent restenosis
   7. Long-lesions (estimated stent length \&gt; 28mm) OR Patient with an indication for PCI for any lesion and in need for elective mechanical circulatory support assisted PCI
3. Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS)
4. All lesions must be suitable for treatment with FDA-approved contemporary generation drug eluting stents or drug-coated balloons
5. The patient is willing and able to cooperate with registry procedures and follow-up until registry completion
6. Subject is able to confirm understanding of risks, benefits and treatment alternatives and he/she (or an authorized legal representative) provides informed consent prior to any protocol-related procedure, as approved by the appropriate IRB

Exclusion Criteria:

1. ST-elevation myocardial infarction or cardiogenic shock within prior 7 days
2. Known untreated severe valvular heart disease
3. Contraindication on the use of IVUS (i.e. extreme vessel tortuosity)
4. Requiring PCI in a diseased aorto-coronary bypass
5. Known contraindication or hypersensitivity to anticoagulants
6. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors
7. Non-cardiac co-morbidities with a life expectancy less than 1 year
8. A patients that is currently participating in a clinical trial that has not yet reached its primary endpoint cannot be included in this registry. A patient may only be enrolled in this registry once.
Remimazolam Tosilate Sedation and Midazolam Sedation in Dental Patients

Remimazolam Tosilate is a new short-acting benzodiazepines used in sedation. It has the advantages of rapid metabolism, quick recovery without injection pain. This study aims to compared with Midazolam, study whether Remimazolam Tosilate can achieve the same sedation effect with lower side effects on sedation maintenance period, During the recovery period of anesthesia, can Remimazolam Tosilatebe more stable and rapid.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-60
2. BMI in 18-30Kg / m2
3. ASA classification I-II level
4. Sign informed consent
5. Patients whose outpatient treatment time less than 1 hour
6. The methods of local anesthesia including: periosteum infiltration method, periodontal ligament injection method, regional nerve block method

Exclusion Criteria:

1. Patients who are allergic to benzodiazepines, opioids, flumazenil or have contraindications
2. Long-term use of benzodiazepines
3. Long-term use of opioids
4. Participate in other clinical trials within 4 weeks
5. Women during pregnancy or breastfeeding
6. Patients who have a history of drug abuse or long-term alcohol abuse
7. Patients who suffer from mental illness or unable to cooperate with the experiment
Perioperative Thoracotomy Analgesia; Different Analgesic Modalities

the study aim is to compare the analgesic effect of thoracic epidural versus serratus plane block versus erector spinae block in thoracic surgeries

comparing the analgesic effect of thoracic epidural versus serratus plane block versus erector spinae block in thoracic surgeries regarding pain control and possible side effects

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for thoracotomy age 18-65

Exclusion Criteria:

* patient refusal coagulation defects abnormal kidney or liver functions local infection at site of block bone metastases
Evaluation of the Diagnostic Value of Video-oculography in CANVAS Neuronopathies

Cerebellar ataxia syndrome with neuropathy and vestibular areflexia (CANVAS) is a genetic pathology of recent discovery (bi-allelic expansion in intron 1 of the RFC1 gene with AAGG repetition). The clinical picture is protean, associating a neuronopathy, a bilateral vestibulopathy evidenced by an alteration of the oculovestibular reflex (VOR), an atrophy of the cerebellum and a chronic cough.

In the initial stage of the disease the clinical picture is heterogeneous and often incomplete. Ataxia at the beginning of the disease may be the consequence of peripheral nervous system involvement (neuronopathy) and the cerebellar syndrome may manifest itself clinically late.

Eye movement involvement in central nervous system pathologies is common (4). Oculomotor abnormalities are often subclinical and sometimes exclusively identifiable by an instrumental study, video-oculography (VOG) (5).

VOG is a non-invasive examination of eye movements, which is increasingly used in the differential diagnosis of neurodegenerative syndromes (6). This examination allows, among other things, to identify oculomotor anomalies, even discrete and asymptomatic, by studying the combined movements of the eyes and the oculocephalic movements.

The study of oculomotricity by VOG can therefore potentially contribute to the early differential diagnosis of ataxiating neuropathies, including CANVAS, by revealing infra-clinical oculomotor abnormalities correlated with a cerebellar expectation (knowing the role of the dorsal vermis in the precision of saccades and pursuits).


Eligibility Criteria:
Inclusion Criteria:

Patients followed at the University Hospital of Nîmes between 2018-2021

* Age \> 18 years
* Patients with CANVAS with genetic confirmation (RFC1 gene mutation)
* Patients with axonal neuropathy, autoimmune neuronopathy and anti-MAG neuropathy
* Healthy controls