cyrilzakka/clinical-trials huggingface dataset:
Hemodynamic Responses of Stable Ischemic Heart Disease Patients to a Comedy Session

It is known that laughter can bring benefits in terms of physiological and psychological parameters, in addition to improving the individual's quality of life. However, the literature is still scarce as to the existence of studies investigating the effects of a comedy film specifically in hemodynamics.

Objective: To evaluate the effect of a comedy film session on the cardiac index, Systemic Vascular Resistance and Vascular Resistance Index Systemic in stable ischemic heart disease patients.

Method: Randomized Clinical Trial. Patients will be coming from Ischemic Heart Disease clinic at the Hospital de Clínicas de Porto Alegre (HCPA), all in regular monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 40 and 80 years
* Both female and male
* Diagnosis of ischemic heart disease by cardiac catheterization , with 50% lesion in at least one epicardial vessel

Exclusion Criteria:

* Participants enrolled in another Randomized Clinical trial
* Autoimmune diseases
* Valvulopathy with mechanical or biological cardiac prosthesis
* Presence of pacemakers and implantable cardioverter
* Left bundle branch block in the electrocardiogram (ECG) of 12 derivations
* Severe lung disease
* Depression or Bipolar Disorder
* Atrial Chronic Fibrillation
* Left ventricular dysfunction (ejection fraction \<45%)
* Active Infection or neoplasia (not Basal cell carcinoma)
* Chronic Renal Failure
* Illiteracy and inability to understand the consent form
Pangenomic Study During Alcoholic Cirrhosis

Hepatocellular carcinoma (HCC) is a frequent complication of cirrhosis. Occurrence of HCC could be linked with multiple functional region of genome.

The determining of a genomic mapping of " single nucleotide polymorphisms " (SNPs) permit to perform some genetic link studies with pathologies without clear hereditary disposition.

In this study, the investigators will identify predictives genetic polymorphism of HCC.


Eligibility Criteria:
Inclusion Criteria:

* 35 to 70 years old
* Compensated cirrhosis or not
* Caucasian origin of the parents
* Patient with cirrhosis (histological proof or obvious)

Exclusion Criteria:

* HIV, HBV, HCV positive
* Known Homozygotia (C282Y+/+)
* Important hepatocytary iron overload for patient with resection
* HCC non histologically prooved
Effects of Dairy- and Berry-based Snacks on Nutritional and Functional Status and Quality of Life in Older People

Malnutrition or its risk is common among older people, especially among those receiving home care services. It impairs the quality of life of the older people and results in significant costs to society. To maintain adequate nutrition, increased meal frequency is important. In addition to main meals, regular consumption of tasty, convenient, nutrient- and energy-dense snacks is recommended. The purpose of this study is to investigate the effects of dairy- and berry-based snack consumption on nutritional and functional status and quality of life among vulnerable older people at home care.


Eligibility Criteria:
Inclusion Criteria:

* Home care clients of the City of Kuopio

Exclusion Criteria:

* Advanced dementia
Baseline ACL Injury Risk Screening and Normative Data

This is a prospective, observational cohort study aimed at establishing a database of normative biomechanics for healthy athletes and surveying these athletes for one year following baseline testing for the occurrence of new musculoskeletal injuries, with a particular emphasis on ACL injuries.

This study is a prospective, observational cohort study aimed at establishing a database of normative biomechanics data for healthy athletes. The primary focus is on quantifying muscle strength, movement patterns, and biomechanics in relation to the risk of musculoskeletal injuries, particularly ACL injuries. The study will also explore the relationship between these biomechanical factors and the occurrence of new injuries over a one-year follow-up period.

The research will involve a large sample size of athletes within the Sanford Health service area, including those participating in organized sports at middle schools, high schools, and universities. Advanced marker less three-dimensional motion capture technology will be employed to gather high-fidelity biomechanical data. This will allow for the development of sophisticated algorithms to assess individual injury risk and facilitate targeted interventions aimed at reducing the likelihood of ACL injuries.

Participants will undergo an injury risk screen, which is a standard component of the athletic camps sponsored by Sanford Sports and Sanford Orthopedics and Sports Medicine. This screen includes assessments of muscle strength and movement biomechanics, along with the collection of demographic and sports participation data. Participants will then receive follow-up surveys at six and twelve months to report any new injuries.

The study is designed to provide essential normative data, which is currently lacking, particularly for tests used in the assessment of ACLR patients. This data will enhance clinicians' ability to evaluate a patient's readiness for return to sport by comparing their performance to robust normative values. Additionally, the study will collect data on other risk factors, such as a history of concussions, to better understand the interplay between these factors and biomechanics in ACL injury risk.

By establishing this comprehensive database, the study aims to improve patient care by informing ACL and ACLR treatment and return-to-play guidelines, ultimately reducing the risk of ACL re-injury in athletes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy athletes participating in formal, organized, competitive sports between the ages of 10 and 65 years old

Exclusion Criteria:

* Athletes who are injured at the time of consent and pregnant individuals
DBS of the Third Ventricle for Cluster Headache and Obesity

Study of Deep Brain Stimulation of the Third ventricle in Cluster Headache and Obesity treatment.


Eligibility Criteria:
Inclusion Criteria :

* Male or female aged between 18 and 65 years
* Ambulatory or hospitalized monitoring
* Fluent in French and able to understand the study procedures, including completing the auto-questionnaires
* Registered in the French social security scheme
* Signed informed consent of the patient will be collected before inclusion in the study
* Cluster Headache or Obesity patients

Exclusion Criteria:

* Contraindication to Magnetoencephalography (MEG) and/or Electroencephalography (EEG)
* Contraindication to Magnetic resonance imaging (MRI)
* All categories of protected persons
DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)

This study will treat patients with CLL/SLL whose disease comes back or is not responding to prior therapy, or if they can not bear side effects of the prior treatment. This study will assess the anti-tumor activity of DZD8586 as monotherapy. It will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body.


Eligibility Criteria:
Inclusion Criteria:

Participants who meet all the following criteria:

1. Male and female ≥ 18 years of age.
2. ECOG performance status 0-2.
3. Confirmed diagnosis of relapsed or refractory CLL/SLL with indication for treatment.
4. Adequate bone marrow reserve and organ system functions.
5. Willing to comply with contraceptive restrictions.

Exclusion Criteria:

Participants who meet any of the following criteria:

1. CNS involvement or Richter transformation.
2. Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, monoclonal antibodies and antibody-drug conjugates within 28 days.
3. Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks.
4. Take vitamin K antagonists or take more than 2 anticoagulants or antiplatelet drugs at the same time. Take proton pump inhibitors or strong CYP3A inhibitors or inducers.
5. Active infection.
6. Clinically significant cardiac disorders or abnormalities. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.
7. Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
8. Another malignancy within 2 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer.
9. Women who are breast feeding.
10. History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.
A Study in Healthy Adult Participants to Assess the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of a Ravagalimab Subcutaneous Formulation in a Pre-Filled Syringe

The objective of this study is to assess the pharmacokinetics, immunogenicity, safety, and tolerability, of subcutaneous formulation of ravagalimab in a pre-filled syringe in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m\^2 after rounding to the tenth decimal at screening.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion Criteria:

* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* Participant using any over the counter and/or prescription medication, vitamins and/or herbal supplements, with the exception contraceptives or hormonal replacement therapies for females, on a regular basis.
* History of any clinically significant sensitivity or allergy to any medication or food.
* No prior exposure to ravagalimab
* Participant using any medications, vitamins, and/or herbal supplements within the 2-week period or 5 half-lives (whichever is longer) prior to study drug administration.
Survey on Return to Work After Stroke

Survey of survivor perspective on critical elements that either facilitate or inhibit return to work after a stroke. Critical elements are queried in areas of finances, stroke impairments, interpersonal support, therapeutic support, organization influences, work or job specific issues and psychological issues.

The objective of this project is to more accurately describe the stroke survivor's perspective on return to work. The survey development included qualitative analysis of a set of interviews with stroke survivors to arrive at the critical elements described above, followed by item development with an expert panel and preliminary testing of the wording and format for legibility. The survey is being administered both on-line and by paper through the mail to a wide range of survivors with the objective of obtaining a large, diverse sample. The ultimate goal of the project is to arrive at a refined set of recommendations to inform stroke survivors, health care professionals and employers to increase their sensitivity to the needs and desires of individual attempting to return to work after stroke.

Eligibility Criteria:
Inclusion Criteria:

* have returned to work, have thought about returning to work, or have tried to return to work

Exclusion Criteria:

* non-stroke disability
* retired or no plan to return to work
MINRIN® Orally Disintegrating Tablet (Fast Dissolving Desmopressin) and Tablets in Treatment of Primary Nocturnal Enuresis

Desmopressin in treatment of nocturnal enuresis (bedwetting).


Eligibility Criteria:
Inclusion Criteria:

* Treatment of primary nocturnal enuresis within an overall therapeutical concept, eg, in cases of failure of other non-medicinal therapies or with indication of a medicinal therapy caused by nocturnal ADH deficiency
* The patients and their parents have been informed about the study and have given their written consent for participation.

Exclusion Criteria:

* The prescription of Minirin® tablets / Minirin® orally disintegrating tablet (fast dissolving desmopressin) is contraindicated
Efficacy and Safety Study of the Therapeutic Vaccine PEP223 in Prostate Cancer Patients

The purpose of this trial is to investigate whether treatment with this new drug will result in lower testosterone levels in men with prostate cancer. At the same time it will be investigated whether the drug induces side effects, and if so, which ones.

Prostate cancer growth is influenced by the male hormone testosterone. Treatment with drugs that stop the production of testosterone often results in a decrease of the tumor or inhibition of its growth. This is particularly important prior to radiotherapy, since radiation can better be focused on the prostate with as a result less frequent or less severe side effects of the radiation.

Most of the drugs used to date to stop the production of testosterone have the disadvantage that initially they may cause a rise of testosterone levels before the production is effectively blocked. The new drug that will be investigated in this trial is a vaccine. The vaccine offers a different treatment modality since it interferes at a different level of the hormonal axis that drives the testosterone production; it will not cause an initial surge.

In this trial the vaccine will be administered three times, testosterone levels will be monitored for a total period of three months.

Eligibility Criteria:
Inclusion Criteria:

* pathological confirmed prostatic adenocarcinoma, clinical stage (c) cT1-3, cN0-1/x, cM0
* baseline testosterone levels of \> 4 nmol/l
* baseline PSA level of \> 10 microg/l
* eligible for hormone therapy
* willingness to comply with the protocol conditions and procedures
* willing and able to give informed consent

Exclusion Criteria:

* clinical evidence of distant metastases
* previous hormonal therapy administered specifically for prostatic carcinoma
* development of another invasive neoplastic disease during the previous 5 years, or concomitant presence of another invasive neoplastic disease, except basal cell carcinoma or squamous cell carcinoma of the skin
* primary or secondary immunodeficiency, including immunosuppressive disease or use of corticosteroids or other immunosuppressive medications
* concomitant administration - or administration during the 12 weeks preceding study inclusion - of immune enhancing medication or testosterone supplements
* concomitant radiotherapy for prostate cancer
* presence of bacterial prostatitis causing a PSA increase during the 8 weeks preceding study inclusion
* simultaneous participation in another clinical trial or participation in a clinical trial involving investigational drugs within 3 months before enrollment into the present study
* BMI \> 30 kg/square meter
* previous serious reaction to a vaccine such as angioedema or anaphylaxis
Binges and Neural Variability

People who suffer from binge eating disorder experience recurrent episodes of binge eating.During these episodes, they consume an unusually large amount of food in a short amount of time and experience loss of control over eating. However, why such binge eating episodes occur is still largely unknown. This makes it difficult to develop targeted treatments. In this project, the experimenters are investigating the brain mechanisms that give rise to the disorder. They hypothesize that the binge eating episodes are due to an increased variability in reward processing, which they will assess repeatedly over days. They will test this hypothesis using mathematical models based on behavioural and MRI measurements that are related to the processing of rewards.


Eligibility Criteria:
Inclusion Criteria:

* Binge eating disorder diagnosis
* Subsyndromal binge eating (control)

Exclusion Criteria:

* high risk of suicide
* co-occurring psychotic, bi-polar disorders, alcohol/substance dependence within the past six months
* lack of capacity for consent
* medical disorders that would affect weight and ability to participate
* insufficient German language skills (assessment will be in German)
* taking medication that would affect weight
* MRI exclusion criteria
* irremovable metal attached to the body (e.g. piercings)
* irremovable medical devices (e.g. pacemakers)
* any trauma or surgery which may have left ferromagnetic material in the body
* large tattoos
* pregnancy
* claustrophobia
Veteran-Centered Outcomes Using Qualitative and Quantitative Methods

The purpose of this study is to modify and develop measures that reflect outcomes that are relevant to recovering Veterans and are sensitive to improvements resulting from innovative gait interventions.

Existing clinically-generated measures, in general, have been developed independent of input from Veterans. The purpose of this collaborative study is to take advantage of qualitative and quantitative expertise from the Gainesville, Florida, Rehabilitation Outcomes Research Center (RORC) with state-of-the-art gait intervention research being conducted at the Gainesville, Brain Rehabilitation Research Center (BRRC) and Cleveland, Functional Electrical Stimulation Center (FESC). Three interventions have received considerable attention for their demonstrated promise in improving gait and mobility in individuals with spinal cord injury and stroke; 1) manually assisted locomotor training (MLT), 2) robotic assisted locomotor training (RLT)and 3) functional electrical stimulation assisted gait training (FES-GT). These interventions will be the basis for improving existing outcome measures and developing new outcome measures. The process of developing and evaluating valid outcome measures requires four phases of development. This study encompasses Phases I and II. Phase I (Year 1 of grant)will involve completing qualitative research studies to identify constructs reflecting the impact of MLT, RLT and FES-GT on Veterans. Data will be systematically collected using ethnographic field observations and in depth, semi-structured interviews. Phase II (Year 2) will involve using the identified constructs to develop item banks for Veterans-centered outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stroke and patients with incomplete spinal cord injuries currently enrolled in locomotor/gait training studies at the VA BRain Rehabilitation Research Center, Gainesville, FL and the VA Functional Electrical Stimulation Center, Cleveland, Ohio, Competence for inclusion in the treatment intervention study (and the present study) is passing the 3-step command component of the Mini Mental Status Exam.

Exclusion Criteria:

* Unable to pass the 3-step command component of the Mini-Mental Exam.
The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression

The present project aims to assess the neurocognitive impact of a two-week once-a-day regimen of intermittent theta burst stimulation (iTBS) compared to sham iTBS, when targeting the left dorsolateral prefrontal cortex (LDLPFC) in clinically depressed outpatients. The study investigates the relationships between changes in cerebral measures and cognitive performance on an N-back task in relation to the antidepressive effect following iTBS.

The study is a randomized sham controlled double blind clinical trial in which the changes in cortical functions associated with the anti-depressive effect of two weeks of once-a-day neuronavigated iTBS over the left dorsolateral prefrontal cortex (LDLPFC) will be investigated in comparison to sham iTBS. Participants will be recruited prospectively, and the study is performed at a single university hospital. After written informed consent is obtained from eligible, volunteering patients, baseline measurements will be administrated, and the patient will be allocated to either sham or active iTBS once a day for 10 consecutive workdays. A total of three measurements will take place, namely at baseline prior to iTBS treatment, after two weeks with iTBS treatment (posttest) and four weeks after (follow-up). The primary outcome measures will be assessed from baseline to the posttest.

Eligibility Criteria:
Inclusion criteria:

* Patients must meet the diagnostic criteria of at least a moderate depression
* The duration of the current depressive episode must have lasted more than 2 weeks but less than 2 years
* Drug therapy must have been stable for the last three weeks prior to the first treatment day with iTBS
* Patients must volunteer to provide informed consent, be able to follow the treatment schedule and have a satisfactory safety screening for iTBS and MRI

Exclusion criteria:

* The current depressive episode is in the mild range
* The current episode fulfills the criteria for a major depressive episode requiring inpatient treatment and/or electroconvulsive therapy,
* The current depressive episode is clearly triggered by grief or a recent major stressful life event
* Bipolar disorder
* Borderline personality disorder
* Psychotic symptoms
* Alcohol or substance abuse/addiction in the last 6 months
* Current eating disorders
* Obsessive- compulsive disorders
* Post-traumatic stress disorder
* A life-time medical history of seizure
* Neurological or neurosurgical pathologies
* Cardiac or systemic disease
* Metallic prosthetic material or foreign objects (pacemakers, prosthetic eye equipment, etc.)
* Autism
* Pregnancy
* Currently using of antipsychotic medication or benzodiazepines - or any medication that interferes with motor threshold excitability
Goal-Directed Fluid Therapy for Patients Undergoing Oro-Maxillofacial Surgery

Orthognathic surgery, one kind of Oro-maxillofacial surgery, is a complicate surgery that undergoes several hours with nasotracheal intubation general anesthesia. To limit blood loss during operation, the patients are often under intentional hypotension. However, the intentional hypotension may confuse with hypovolemic induced low blood pressure. The hypothesis is using flotrac (to measure stroke volume variation) to keep the patients hemodynamics stable under Tridil and propofol infusion and avoid over-infusion of crystalloid or colloid and prevent hypovolemia induced postoperative nausea and vomiting.

Orthognathic surgery, one kind of oro-maxillofacial surgery, is a complicated surgery that undergoes several hours with nasotracheal intubation general anesthesia. Patients without premedication undergo orthognathic surgery with nasotracheal intubation general anesthesia.

Patients without premedications Monitoring of patients with entropy for consciousness, ECG, with noninvasive BP and invasive blood pressure through redial artery, train-of-four monitor, target controlled infusion of propofol, infusion Tridil, and sevoflurane for mainly anesthesia maintenance. Ventilator setting as volume control (8-12ml/kg), frequency respiratory rate (8-12/min), I/E ratio: 1/2, positive end expiratory pressure: 4 mmHg, Fraction inspiratory O2: 60%.

To maintain the MAP \>60-55 mmHg, urine output 0.5-1ml/kg, and body core temperature \> 36 Celsius degree.

Closely observation of patients postoperatively for adverse events or complications.

Eligibility Criteria:
Inclusion Criteria:

* patients undergo orthognathic surgery, ASA I\~III, 20 to 65 years old, no mouth limitation

Exclusion Criteria:

* ankylosing spondylitis, limited mouth opening \< 3 cm, liver or renal disease, obese patients (BMI\>35kg/m2), patients refused