cyrilzakka/clinical-trials huggingface dataset:
Reiki Effects on Heart Rhythm, Biochemistry and Cortisol Findings, and Anxiety

This study aimed to investigate the effects of Reiki, which is a complementary and traditional method, on heart rhythm, biochemistry and cortisol findings, and anxiety in individuals with arrhythmia.

Reiki has an essential place in modern medicine and the nursing profession because it cures many diseases resistant to known treatments, has no side effects, is easy to apply, and is safe, effective, and economical. In the Reiki method, the energy is transferred through the hands, and a care provider nurse is a tool that performs their profession by touching in patient care and also shares the universal life energy, transferring the flowing and formed energy. When the literature is reviewed, there are a limited number of studies in which Reiki affects heart rate, cortisol level, and vital signs. However, there are not enough studies examining the effects of heart patients' symptoms, anxiety, and their condition on Reiki results. In this context, this study aimed to investigate the effects of Reiki energy on heart rhythm, biochemistry, cortisol findings, and anxiety in people with arrhythmia.

The study was conducted as a pretest-posttest, randomized prospective, single-blind and placebo-controlled. The study was conducted with patients who applied to a training and research hospital with arrhythmia complaints between April 5 and June 30, 2022. The data was collected using "Personal Information Form (PIF)" and "Beck Anxiety Scale (BAS)". Also, biochemical tests and cortisol findings and ECG (Electrocardiography) analyses were assessed.

PIF and BAS were applied to patients who agreed to participate in the study and met the inclusion criteria. Then blood was drawn for biochemical tests and cortisol findings and EKG was taken. Patients were randomized 1:1 into groups by a single therapist at a single institution according to a parallel design. There were three treatment arms in the study: Reiki treatment (n=22), Sham Reiki treatment (placebo)(n=22), and a control group with no treatment (n=22). A second-degree Reiki practitioner applied Reiki to the energy centers for 30 minutes in the Reiki group. On the second day, distant Reiki was also conducted for 30 minutes. The Sham Reiki group, on the other hand, was handled similarly to the Reiki practice by a student who had not been trained in Reiki. In the control group, nothing was done. One week later, BAS was applied to all patients, blood was drawn for biochemical testing and an ECG was recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* No communication problem
* Diagnosed with cardiac arrhythmia
* Who agree to participate in the Reiki practice
* Who is competent to answer the data collection tools to be used in the research
* Patients who have not used complementary practices in the last six months

Exclusion Criteria:

* Reiki practitioner or trainer,
* Have received energy therapies such as Reiki/therapeutic touch,
* Patients who were diagnosed with another disease during the research process.
How to Collect the Expression of Psychological Suffering of Children Under Two Years?

Emotional Neglect (NE) is a form of abuse to the child whose prevalence is high (WHO Europe). Experiencing NE, psycho-emotional development and brain child may be impacted generating psychic suffering signs may progress to severe developmental disorders. The recognition of suffering can prevent and treat these disorders.

This research promotes a multi-professional device, centered on observation, collection of expression of the baby's psychic pain (≤ 2 years) living in vulnerable families. The investigators assume that this collection requires the crossing of looks of a child psychiatrist and a repeated observation at home by a trained nurse.

The two devices described in these two groups are devices set up as part of the routine management of these patients. Usually, depending on the means of structures (human and financial), one of these devices may be preferred over another.


Eligibility Criteria:
Inclusion Criteria:

* Families say vulnerable falling M.Heaman selection criteria associated with two significant items of Q-Sort, agreeing to participate in the research project.
* Patient 24 months or less at the time of the first consultation PMI.
* Parents / legal representatives agreeing to participate in the research project.

Non inclusion Criteria:

* Serious genetic and somatic pathologies resulting deficiency, physical pain,
* Non-French speaking families.
* Families whose baby is monitored as part of the network grow together because of their prematurity.
* Minor or major Parents Trust
Evaluation of an Updated Version of the Program "BlinkBlink" for Alleviation of Dry Eye Symptoms Induced by Computer Work

The program "BlinkBlink" was developed to alleviate dry eye symptoms during prolonged computer work. This study aimed to show subjective and objective improvement of dry eye problems in a sample size of office workers

The increased use of digital devices and the resulting increase in near work has increased the prevalence of dry eye disease (DED).

Studies show that blink frequency reduced considerably during computer work, hence the tear film is spread less regularly over the anterior surface of the eye giving rise to an unstable tear film. This may lead to tired, dry eyes.

The aim of this study was to observe if the tear film quality and dry eye symptoms may improve with the use of the computer animation program "BlinkBlink" during prolonged computer work. Participating subjects test two versions of the program, whereby one version applies the animation in a much lower frequency, hence serving as a near placebo version. The testing order of the versions is randomized.

The variables tested in this study are non-invasive tear film break up (NIBUT) and subjective dry eye symptoms with the Ocular Surface Disease Index (OSDI) questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* duration of computer work of at least six hours per day during at least four days per week
* OSDI score ≥ 18
* no active pathology on the anterior eye
* Snellen visual acuity of ≥ 0.8.

Exclusion Criteria:

* acute systemic disease
* contact lens wear
* asthenopia
MicroRNA as Markers in Testicular Cancer

The main objective of this study is establish the performance of miR371 in management of testicular cancer

The main objective of the study is to asses the sensitivity and specificity of microRNA-371a-5p (miR371) in detection of viable testicular germ tumour cells. To assess the utility of miR371 at orchiectomy, during treatment and surveillance and in early detection of recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected testicular cancer, referred to orchiectomy.
* Patients diagnosed with testicular germ cell cancer.
* Age 18-70 years of age.
* Must be able receive information and to consent.

Exclusion Criteria:

* Other prior or concomitant malignancy (other than testicular cancer).
* Other diseases or conditions that hinder the ability to receive information and to participate in follow-up procedures.
A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC

The 3 FDA-approved CDK4, 6 inhibitors, palbociclib, ribociclib, and abemciclib, all provided progression-free survival benefits when combined with endocrine therapy in advanced ER+/HER2- breast cancer. But, not all of them provided overall survival benefit in the same setting. One of the proposed mechanisms that influence the overall survival difference is from the different influence of the 3 CDK4, 6 inhibitors on tumor microenvironment and/ or immune system. However, there was no head-to-head comparison of the 3 CDK4, 6 inhibitors in the same study. Neoadjuvant therapy provides a window to obtain tissue samples before treatment, during treatment, and after treatment. We aim to compare the immune modulation effects of palbociclib, ribociclib, and abemaciclib with letrozole in neoadjuvant treatment for ER+/HER2- early breast cancer.

The 3 FDA-approved CDK4, 6 inhibitors, palbociclib, ribociclib, and abemciclib, all provided progression-free survival benefits when combined with endocrine therapy in advanced ER+/HER2- breast cancer. But, not all of them provided overall survival benefit in the same setting. One of the proposed mechanisms that influence the overall survival difference is from the different influence of the 3 CDK4, 6 inhibitors on tumor microenvironment and/ or immune system. However, there was no head-to-head comparison of the 3 CDK4, 6 inhibitors in the same study. Neoadjuvant therapy provides a window to obtain tissue samples before treatment, during treatment, and after treatment. We aim to compare the immune modulation effects of palbociclib, ribociclib, and abemaciclib with letrozole in neoadjuvant treatment for ER+/HER2- early breast cancer. We will collect tumor tissue, blood, and stool samples prospectively before treatment, at 2 weeks after treatment, and after 12 weeks of treatment at the time of surgery. Immune modulation effects will be compared between 3 treatment groups from breast tumor RNAseq analysis.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged ≥ 20 years old at the time of informed consent.
* Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory. with estrogen receptor positive (\>10%) on IHC staining and HER2 negative (IHC 0+/1+, or IHC 2+ plus FISH negative)
* Stage II to III
* With adequate organ function
* ECOG 0-1

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* Women of child-bearing potential unless using highly effective methods of contraception during study drug dosing and for 12 months post-dosing
* Patients with active systemic infections or known to have AIDS or to test positive for HIV antibody at Screening
* Any other disease or condition that could interfere with participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures.
Identification of de Novo Fanconi Anemia in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

This research study is studying identification of de novo Fanconi anemia in younger patients with newly diagnosed acute myeloid leukemia. Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to Fanconi anemia in patients with acute myeloid leukemia.

PRIMARY OBJECTIVES:

I. Identify children with newly diagnosed acute myeloid leukemia (AML) treated on COG-2961 and COG-AAML03P1 who are at high risk of having de novo Fanconi anemia.

II. Procure diagnostic samples from the COG AML Biology Repository and identify Fanconi anemia patients using western blot techniques.

OUTLINE:

Previously collected cryopreserved cells are analyzed via western blot to identify patients with Fanconi anemia.

Eligibility Criteria:
Inclusion Criteria:

* Treated on COG-2961 or COG-AAML03P1
* At high risk of having Fanconi anemia, defined as meeting one the following groups of clinical criteria:

  * Group 1: Prolonged neutropenia after induction, severe regimen-related toxicity (mucositis, veno-occlusive disease, end-organ damage)
  * Group 2: Early non-relapse death (induction, consolidation)
  * Group 3: Small-for-weight, secondary malignancies
A Single Dose, Tolerance and Pharmacokinetic Study in Obese or Overweight Type 2 Diabetic Volunteers

The purpose of this study is to evaluate the safety and tolerance of a single intravenous (through a vein) dose of trodusquemine (MSI-1436) in obese, type 2 diabetics.

Different amounts of trodusquemine (MSI-1436) will be given to each volunteer group throughout the study.

Another purpose is to evaluate the pharmacokinetics (PK - the study of the way the drug enters and leaves the blood and tissues over time) of trodusquemine (MSI-1436).

Finally, this study will also determine whether trodusquemine (MSI-1436) has any effect on appetite, mood or behavior, and selective biomarkers (substances in your blood that may change in response to the study drug).


Eligibility Criteria:
Inclusion Criteria:

1. male or female obese or overweight type 2 diabetic subjects, between 18 and 55 years old (inclusive)
2. either treatment naive or who are inadequately controlled on either metformin alone or metformin in combination with a sulfonylurea. Subjects on metformin in combination with a sulfonylurea will be allowed a 2 week period to wash out the sulfonylurea before dosing.
3. have a fasting blood sugar of ≥ 100 mg/dL, hemoglobin A1C ≥ 7.5% (but ≤ 11.0%). Subjects on a combination of metformin and sulfonylurea must have a hemoglobin A1C ≥ 7.5% (but ≤ 10.0%);
4. non-smoker
5. body mass index (BMI) of 27-40 kg/m2

Exclusion Criteria:

1. likely allergy or sensitivity to any components of Trodusquemine (MSI-1436) for Injection based on known allergies to drugs of the same class;
2. any subject with a history of allergy (rash, hives, breathing difficulty, etc.) to any medications, either prescription or nonprescription, including dietary supplements or herbal medications;
3. any subject with a history of severe allergy or bronchial asthma;
4. a clinically significant history of or current abnormality or disease of any organ system, including renal, hepatic, gastrointestinal, cardiovascular (except hyperlipidemia or controlled hypertension), pulmonary (including chronic asthma), endocrine (except diabetes), central nervous, or hematologic systems, or recent clinically significant surgery;
Telephone Psychotherapy for Late-Life Generalized Anxiety Disorder (GAD)

The purpose of this study is to determine if cognitive-behavioral therapy (CBT)and supportive therapy delivered by telephone are effective for reducing worry and anxiety in rural older adults with Generalized Anxiety Disorder (GAD).

Older adults in rural locations often face significant barriers to treatment, including stigma, transportation, lack of local appropriately trained service providers, and impaired mobility. The proposed treatment is delivered in a workbook format and by telephone, which maximizes its portability. Treatment will be compared with nondirective supportive therapy, a very credible comparison condition equivalent to the intervention in therapist attention. We propose to randomize 88 adults ≥ 60 years with a diagnosis of GAD to either cognitive behavioral therapy delivered by telephone, or nondirective supportive therapy. The 2 primary treatment outcomes are anxiety symptoms as assessed by the Hamilton Anxiety Rating Scale, and worry symptoms as assessed by the Penn State Worry Questionnaire-Abbreviated. The proposed secondary outcomes are depressive symptoms, sleep, disability, and quality of life. Further, mediators and moderators of the treatment effect will also be examined. Mediators include process variables (therapeutic alliance, adherence, participant satisfaction, and treatment credibility) and new psychotropic medication use; moderators include demographic information (age, education, gender, race, income), psychiatric variables (baseline anxiety severity, baseline depressive disorders, baseline psychotropic medication use), medical comorbidity, and therapist assignment. Maintenance of response will be assessed over 6 months. This research has great public health significance, because it is a low-cost intervention with high potential for widespread dissemination, and it targets an underserved group - community-dwelling rural elders - who currently lack effective treatment interventions tailored to their needs.

Eligibility Criteria:
Inclusion Criteria:

* 60 years GAD Reside in rural county Proficient in English

Exclusion Criteria:

Current psychotherapy Active alcohol or substance abuse with use within last month Dementia or global cognitive impairment Psychotic symptoms Active suicidal ideation with plan and intent Change in psychotropic medications within last 1 month Significant hearing loss
Hypothermia in Acute Stroke With Thrombolysis Imaging Evaluation of Revascularization

The primary objective of this Phase 2 HASTIER study, as an ancillary study to ICTuS 2, is to compare key imaging measurements for serial changes in recanalization and reperfusion between hypothermia and normothermia treatment arms as intermediate outcomes of treatment effect. Secondary exploratory analyses include imaging of the neurovascular impact of reperfusion with hypothermia and tPA, including blood-brain barrier changes or permeability, hemorrhagic transformation, and infarct growth.

A prospective imaging ancillary study coincides with recruitment of ICTuS 2 by using currently available imaging tools at a subset of multicenter sites. HASTIER will evaluate therapeutic response with imaging outcome measures for recanalization and reperfusion. Key scientific objectives include the evaluation of hypothermia on benchmark recanalization and reperfusion rates in 120 cases of middle cerebral artery (MCA) stroke. Recanalization will be measured with Thrombolysis in Myocardial Infarction (TIMI) score change from baseline-36 hour CT/MRI angiography. Reperfusion will be measured with Tmax \> 6s lesion volume change from baseline-36 hour CT/MRI perfusion imaging. Secondary outcomes will be measured with serial changes in permeability abnormalities derived from CT/MRI perfusion imaging, hemorrhagic transformation, and infarct growth from baseline-36 hours. Correlation of these imaging parameters with clinical outcomes will provide insight to accelerate research during these translational steps in hypothermia treatment for acute ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for inclusion in the ICTuS 2/3 trial.
* Diagnosis of MCA stroke, confirmed by M1 or M2 proximal MCA occlusion on CT/MRI angiography.

Exclusion Criteria:

* Kidney dysfunction of such severity as to preclude routine administration of contrast media for CT/MRI angiography or perfusion imaging. Severe kidney dysfunction is defined by the American College of Radiology recommendations for use of contrast media.
* Known adverse reaction or allergy to such contrast media.
Clinical and Magnetic Resonance Imaging Evaluation of Micro Fragmented Adipose Tissue Injection Combined With Bone Marrow Stem Cells on Healing of Temporomandibular Joint Internal Disc Derangement Without Reduction

Arthrocentesis of TMJ then injection of micro fragmented adipose tissue mixed with bone marrow aspirate on healing of TMJ internal disc derangement without reduction.

Arthrocentesis of TMJ then injection of intra and periarticular of 2 mm of micro fragmented adipose tissue mixed with Bone marrow aspirate extracted from 20 mm of bone marrow using gradient separation method in one group and use of Bone marrow aspirate injection only in another group and injection of intra and periarticular of 2 mm hyaluronic acid gel in control group on healing of TMJ internal disc derangement without reduction.

Eligibility Criteria:
Inclusion Criteria:

* Patients with TMDs not previously surgically treated.
* Patients with TMJ osteoarthritis assessed by clinical examination and magnetic resonance imaging.

Exclusion Criteria:

* Patients refuse to be enrolled in this study.
* Patients with uncontrolled systemic disease.
Developing and Validating a Food Frequency Questionnaires (FFQ) for the Vegan Population in Israel

The study aims to validate a Food Frequency Questionnaire (FFQ) designed specifically for the vegan population in Israel. The participants will complete the FFQ, and the data will be verified by evaluating the participants energy expenditure (by measuring BMR, body composition and daily activity) and conducting a 24-hour food interview.


Eligibility Criteria:
Inclusion Criteria:

* consumption of beef, chicken, fish, eggs, milk or dairy is no more than once a month, for the last 6 months
* age 18-40

Exclusion Criteria:

* consumption of beef, chicken, fish, eggs, milk or dairy more than once a month
* chronic conditions (such as diabetes, hypertension, cardiovascular disease)
Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment

The purpose of this study was to evaluate the effect of SPN-810 for the treatment of impulsive aggression (IA) in adolescents diagnosed with ADHD when taken in conjunction with standard ADHD treatment.

This study was an addition to the pediatric studies (CHIME 1 and CHIME 2) to assess the efficacy and safety of SPN-810 in the improvement of impulsive aggression (IA) behaviors in adolescents with ADHD.

SPN-810 was administered in patients diagnosed with ADHD and associated features of IA, who were currently treated with an FDA-approved standard ADHD treatment and displayed persistent IA behaviors. The frequency of impulsive aggressive behaviors was assessed as a primary outcome.

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Eligibility Criteria:
Inclusion Criteria:

* Otherwise, healthy non-smoking, male and females adolescents (12-17 years of age at the time of screening) with a primary diagnosis of ADHD and currently taking an optimized FDA-approved ADHD medication.
* IA confirmed at screening using R-MOAS scale and Vitiello Aggression Questionnaire.

Exclusion Criteria:

* History or current diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia and other psychotic disorders, personality disorder, Tourette's syndrome or dissociative disorder, autism spectrum disorder, pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or intermittent explosive disorder.
* Currently meeting DSM-5 criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder or intermittent explosive disorder.
* Known or suspected intelligence quotient (IQ) \<70, active suicidal plan/intent or active suicidal thought, criminal arrest, alcohol or drug use or pregnancy.
Motivational Interviewing and Medication Review in Coronary Heart Disease

Low medication adherence in patients with coronary heart disease increases mortality.

This study investigates if an intervention of medication review and counselling can improve patients' medication adherence and treatment results.

The study will investigate the effects of medication review and Motivational Interviewing (MI) on patients with Coronary Heart Disease (CHD). Clinical pharmacists competent in MI and cardiology will conduct medication interviews and medication reviews at the outpatient clinic. The intervention will continue during 9 months, with interviews and reviews as needed.

Follow-up of results will take place 16 months after inclusion (corresponding to 4 months after the end of intervention).

The MI-Component will be quality assured by MITI 4.2-coding (Motivational Interviewing Treatment Integrity). The study will investigate effects on clinical outcomes, medication adherence, patients´ beliefs about medicines and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Admitted for angiography
* Verified Coronary Artery Disease (ICD-10 I20-I21)
* Planned for follow up at the out-patient clinic (standard treatment)
* Swedish speaking

Exclusion Criteria:

* Cognitive impairment or any othe condition making interview or phone calls impossible.
* Non-participation in the standard follow-up
* Prior participation in this study