cyrilzakka/clinical-trials huggingface dataset:
Positive Psychology for Chronic Pain Self-management

Learning chronic pain self-management skills can help patients improve daily functioning and quality of life, while avoiding risks associated with opioids and other pharmacological treatments. Community health workers (CHWs) may help make chronic pain self-management interventions more accessible to older adults living in underserved communities. The goal of this study is to conduct a randomized pilot and feasibility trial of a positive psychology-based chronic pain self-management intervention delivered by CHWs, in conjunction with mobile health tools, in a sample of 50 older adults recruited from community sites in Detroit, Michigan. This study will involve the use of mixed quantitative and qualitative methods to assess participant engagement and satisfaction, and change in pain-related outcomes.


Eligibility Criteria:
Inclusion Criteria:

* English-proficient
* Ambulatory with or without assistive device
* Community-living
* Have a cell or landline phone
* Have Internet access (home or elsewhere);
* Self-reported chronic musculoskeletal pain (pain in muscles or joints for \> 3 months); \>4 (0-10 scale) average pain level over last week; \>1 day/previous 30 when pain made it difficult to do usual activities.

Exclusion Criteria:

* Serious acute illness or hospitalization in last month
* Planned surgery in next three months
* Severe cognitive impairment or other severe physical or psychiatric disorder judged by study team to pose significant barrier to deriving program benefit
Brief Multifamily Psychoeducation for Families of Patients With Chronic Major Depression

The purpose of this study is to examine the effectiveness of brief multifamily psychoeducation to relieve the psychological distress of families of patients with chronic major depression and to improve their family functioning.

Major depressive disorder (MDD) is a long-lasting illness with significant effects on the patient's family, social life, and work life. Treatment failure results in a low recovery rate and frequent relapses.

Relatives of patients with MDD are fraught with heavy psychosocial burden and show increased rates of depression and anxiety. Among relatives of patients with MDD, the patient's behavior and mood disturbance and relative's emotional distress were associated with the relatives' burden.

Family psychoeducation is recognized as part of the optimal treatment for patients with psychotic disorder. This intervention has been shown to reduce the rates of relapse and hospitalization among individuals with psychotic disorders and is recognized as an evidenced-based treatment for psychotic disorder. Several randomized controlled trials have found that family psychoeducation is effective in enhancing the course of bipolar disorder. However, there are few studies on psychoeducation of families of patients with MDD.

The purpose of this study is to examine the effectiveness of brief multifamily psychoeducation to relieve the psychological distress of families of patients with chronic major depression and to improve their family functioning, in a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

1. Meets the criteria for Major Depressive Disorder (MDD) according to DSM-IV.
2. Receives antidepressant therapy.
3. The patient had the first episode of MDD more than one year ago.
4. Currently fulfills the diagnostic threshold for major depressive episode or partial remission.
5. The patient and their family member(s) are aged between 18 and 85 years.
6. The patient has lived with his/her family at the time of participating in this study and is expected to live with his/her family during the investigation period.

Exclusion Criteria:

1. Patients who undergo electroconvulsive therapy (ECT) during the investigation period.
2. Patients who are at serious suicidal risk.
Effect Of Adding Mindfulness Meditation To Cognitive Behavioral Training On Pain And Quality Of Life In Fibromyalgia

this study will be conducted to investigate The Impact Of Adding Mindfulness Meditation to Cognitive Behavioral Training On Pain And Quality Of Life In Fibromyalgia.

Fibromyalgia syndrome (FMS) is a disorder characterized by chronic, widespread musculoskeletal pain. Muscle and joint stiffness, insomnia, fatigue, mood disorders, cognitive dysfunction, anxiety, and generalized sensitivity are the main manifestations of this disease .Cognitive-behavioral training presents as an important therapeutic resource, as it is capable of modifying patient's negative thoughts and expectations, improving mood, stress, coping with pain and problem solving, including behavioral interventions that specifically deal with improving the fibromyalgia symptoms (sleep hygiene, re-laxation training, activity rhythm).Mindfulness meditation is the intentional effort to pay nonjudgmental attention to present-moment experiences and sustain this attention over time. The aim is to cultivate a stable and nonreactive present-moment awareness. Mindfulness Based Pain Management has been evaluated and showing significant positive changes in patients with chronic pain, with medium to large effect sizes on self-report measures of depression, positive outlook, pain acceptance. fifty women with fibromylagia will be assigned randomly to two groups; first one will receive mindfulness meditation for 30 minutes in addition to mobile application-based brain training program and the second one will receive mobile application-based brain training program alone

Eligibility Criteria:
Inclusion Criteria:

* Confirmation of a clinical diagnosis of fibromyalgia by the patient's own physician.
* Wide spread pain for at least 3 months and tenderness at a minimum of 11of the 18 specific tender point sites.
* Age between 30 and 40 years.
* Female gender.
* BMI: 25-30 kg/m2

Exclusion Criteria:

* Pregnancy
* drug addicition
* Any current psychiatric disorder that would interfere with pro-gram adherence.
* Life-threatening disease
Cardio-metabolic Risk Factors, Osteoporosis and Thrombus Embolic Assessment, Along Woman's Life

Background: It is well known that health risks change during lifespan. The weight of a single risk factor increases with aging. The clinical significance of a single risk factor is clear but there is a lack on the effectof multiple risk factors linked together along different hormones condition of women's life in particular regarding to metabolic syndrome, osteoporosis, and thromboembolic risk.

Aim: 1) characterization and follow up of cardiometabolic risk in women of childbearing age; 2) characterization and follow up of cardiometabolic risk and osteoporosis in menopausal-transition women and in post-menopausal women;

Background: It is well known that health risks change during lifespan. The weight of a single risk factor increases with aging. The clinical significance of a single risk factor is clear but there is a a lack on the effectof multiple risk factors linked together along different hormones condition of women's life in particular regarding to metabolic syndrome, osteoporosis, and thromboembolic risk. Moreover some pathological but reversible conditions during pregnancy may represent an incursion in metabolic syndrome and a sing of future cardiovascular disease.

Aim: 1) characterization and follow up of cardiometabolic risk in women of childbearing age; 2) characterization and follow up of cardiometabolic risk and osteoporosis in menopausal-transition women and in post-menopausal women; in outpatients referring to FTGM Ambulatory of cardiovascular gynecology and osteoporosis in Pisa.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients referred to the Gynecologic Endocrinology and Osteoporosis Unit of Fondazione CNR-Regione Toscana G. Monasterio, Pisa, Italy, who have authorized the use of their personal data

Exclusion Criteria:

* History of/or current neoplastic disease
Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea

The primary objective of this post-marketing surveillance study is to collect and assess data related to the safety and effectiveness of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF)) treatment regimen, per the approved Korea prescribing information for Harvoni, in routine clinical practice in Korea and to report the results to the Ministry of Food and Drug Safety (MFDS). Participants will be treated as part of routine practice at Korean healthcare centers by accredited physicians.


Eligibility Criteria:
Key Inclusion Criteria:

* Individuals aged 12 years and older who are living in Korea
* Adult individuals who have been informed of all pertinent aspects of the study and have voluntarily signed a Personal Information Protection Act (PIPA) consent form; Pediatric individuals who have the individuals' legally authorized representatives sign the PIPA consent form

Key Exclusion Criteria:

* Individuals treated with Harvoni outside of the approved prescribing information in Korea
* Individuals who have a contra-indication to Harvoni
* Individuals who have a contra-indication to ribavirin
* Pregnant or breastfeeding women
* Individuals who have previously been administered Harvoni
* Individuals participating in a concurrent HCV clinical trial
* Individuals planning on leaving the country during the study period

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer

The current study involves a novel and aggressive therapeutic approach for patients' prostate cancer. In addition, the investigators propose to administer hormonal therapy to patients with an especially high risk: those with initial Gleason scores of \> 6, PSA \> 10 ng/ml, T3/T4 primary tumors, and those found to be node positive (N+). The use of hormonal therapy in these specific settings correlates with our current standard of care. IMRT is better able to spare and protect normal tissues from receiving radiation than 3-D conformal RT. The radiotherapy would be followed by continued hormonal therapy for a total of 6 months in those who have one of the following Gleason 7 and PSA 10-20 and as per the previous version of this trial, 1 year similar to that delivered by the EORTC for higher risk patients, (those with initial Gleason scores of \> 8, PSA \> 20 ng/ml, or T3/T4 tumors). Those found to be N(+) would have the hormonal therapy continued indefinitely or until disease progression occurred in a manner analogous to the Messing et. al. series in prostatectomy patients. The goals are to develop and administer a program of treatment that includes the most recent developments in imaging, integrating data from both the CT scan and the ProstaScint scan to optimize prostate cancer RT. The CT scan will be used for staging and to determine the exact location of the entire prostate which will receive a reasonable dose of RT. The ProstaScint will be used to assess the spread of disease to lymph nodes as well as to determine the exact location of the tumor within the prostate gland. This region will then be boosted to a tumorcidal dose. The investigators then plan to monitor the toxicity and outcome of this treatment. The investigators expect that this program of radioimmunoguided IMRT will likely result in similar or less toxicity and increased cure rates when compared to conventional radiotherapy and standard IMRT programs.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pathologically proven prostate cancer
* No evidence of distant metastases (M0) on physical examination, bone scan
* ECOG PS 0,1,2
* Adequate organ function as evidenced by:

  * Hemoglobin \> 10.0 gm/dl
  * White blood count \> 3000/mcL
  * Platelet count \> 90,000/mcL
  * AST \< 2x normal
* Age \> 18 years
* Patients can not be allergic to Leuprolide or Goserelin if the pretreatment PSA \> 20, Gleason Score \> 8, T3/4, or N1 disease
* Written informed consent
* We anticipate enrolling at least 50 patients per year, which would bring accrual to projected total of 100 patients in 2 years

Exclusion Criteria:

* None
The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning

The purpose of the study is to see if galantamine HBr (Razadyne) is safe and can help treat problems with thinking and memory caused by electroconvulsive therapy (ECT).


Eligibility Criteria:
Inclusion Criteria:

* Criteria to enter the study include males and females between the ages of 18-90 (females must be post menopausal) and a DSM-IV diagnosis of Major Depressive Disorder, Major Depressive Disorder with psychotic features, Bipolar Disorder, depressed type, or Schizoaffective Disorder, depressed type (19).

Exclusion Criteria:

* DSM-IV diagnoses of dementia and its subtypes
* Substance use disorder (active use within the last 6 months)
* Organic mental disorders; seizure disorder
* Unstable physical disorder or physical disorder judged to significantly affect the central nervous system function
* A heart rate of \<60
* A systolic blood pressure \< 90
* Heart block
* Pre-existing sick-sinus
* Chronic treatment with beta blockers
* Any cardiac arrythmia
* Hypotension
* Coronary artery disease
* Liver and renal function impairment
* Urge incontinence, colitis Crohn's disease, GI motility disorders, asthma and COPD
* Treatment with anti-cholinergic and cholinomimetic medications; and
* Female patients who are pregnant.
* Additionally, women subjects must be postmenopausal, surgically sterile, or using prescription oral contraceptives (e.g. estrogen-progestin combinations) , contraceptive implants (e.g. NorplantTM, DepoProveraTM ), or transdermally delivered contraceptives (Ortho EvraTM) before entry and throughout the study; and have a negative serum b-HCG pregnancy test at screening.

Note: Abstinence and the use of double barrier contraceptive methods are not acceptable in this study.
Mental Imagery in Menstrual Cycle Phases

Hormonal fluctuations occur during the menstrual cycle and can affect cognition. For example, an increase in estrogen levels has been reported to temporarily enhance auditory perception of newly formed stimuli. It has been suggested that fluctuations in hormone levels can alter cognitive performance throughout the menstrual cycle because these fluctuations impact the neurobiology of the brain regions involved in cognition and emotion processing. Mental imagery (MI) refers to the mental process in which an individual imagines performing a movement without actually executing the movement. The effects of hormonal fluctuations on cognitive-perceptual skills have been mentioned above. In light of the above information, this study was planned to examine the relationship between menstrual symptom characteristics and mental imagery ability and to compare women s mental imagery abilities according to the phases of the menstrual cycle.


Eligibility Criteria:
Inclusion criteria

* Being a woman between the ages of 18-25,
* Having a regular menstrual cycle,
* Being a volunteer Exclusion criteria
* Using neuropsychiatric medication that may affect perception and cognitive skills.

People who do not participate in any of the four assessments will be excluded from the study.
Transfusion Surveillance in Anaesthesia

the aim of this register is to collect exhaustively the different data available surrounding a transfusion act in the context of an active haemorrhage. The aim is to allow different modelling and analysis related to emergency transfusion.

the aim of this register is to collect exhaustively the different data available surrounding a transfusion act in the context of an active haemorrhage. The aim is to allow different modelling and analysis related to emergency transfusion.

Patients will be informed at the time of the anaesthesia consultation about the inclusion in the registry.

The data will be collected from the patients' files by the investigators of the centre without modifying their management.

The data collection period will not exceed the period of acute management.

Eligibility Criteria:
Inclusion Criteria:

* all patients who have received an hemostasis product

Exclusion Criteria:

* patient who refused to consent to data analysis and study participation
Efficacy of Licorice on Reducing Salivary Streptococcus Mutans Versus Chlorohexidine in Caries Risk Patients

To compare the effect of a natural herbal licorice containing preventive measure alternative to chlorohexidine preventive measure to decrease the effect of streptococcus mutans.

A total number of fifty-two patients will be enrolled in the study. They will be divided into two groups: study group and control group. Study group will be subjected to licorice mouthwash and the control will be subjected to chlorohexidine mouth wash. Salivary bacterial count will be evaluated for both groups.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* co-operative patients
* not allergic to licorice
* not allergic to chlorohexidine

Exclusion Criteria:

* pregnancy
* allergic patients to licorice
* allergic patients to chlorohexidine
* lack of compliance
* evidence of parafunctional habits
* patients with periodontal disease
* xerostomia
* participants that receive any microbial agent two weeks prior to the study
Effect of Macrolide Antibiotics on Airway Inflammation in People With Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease (COPD) is a chronic lung disease. Azithromycin, an antibiotic, may be beneficial at reducing the symptoms and severity of the disease. This study will analyze previously collected study data to evaluate the anti-inflammatory properties of azithromycin and determine how azithromycin affects the frequency and severity of COPD exacerbations.

COPD is a disease in which the lung airways are partly damaged and obstructed, making it difficult to breathe. The most common cause is cigarette smoking, but breathing in other types of lung irritants, including pollution, dust, and chemicals, over a long period of time may also contribute to COPD. It is the fourth leading cause of death in the United States. Symptoms include coughing, excess mucus production, shortness of breath, wheezing, and chest tightness.

Some bacterial infections may worsen COPD exacerbations. Current studies are examining if the macrolide antibiotic azithromycin may be beneficial at reducing the frequency and/or severity of COPD exacerbations. Azithromycin also has anti-inflammatory properties that may reduce the severity of COPD exacerbations by inhibiting the matrix metalloprotease (MMP)-catalyzed breakdown of collagen and the subsequent generation of proline-glycine-proline (PGP), a substance produced in response to collagen breakdown. An increase in PGP levels may indicate an increase in inflammation, which can worsen COPD symptoms. NHLBI's COPD Network Macrolide study includes people with COPD who were randomly assigned to receive either azithromycin or placebo for 1 year. For this current study, researchers will examine the Macrolide participants' previously collected blood samples, sputum samples, and study data, including information on COPD exacerbations and azithromycin effects. The purpose of this study is to examine the anti-inflammatory properties of azithromycin in people with COPD.

Eligibility Criteria:
Inclusion Criteria:

* Participating in the COPD Network Macrolide study
* Clinical diagnosis of at least moderate COPD
* Cigarette consumption of 10 pack years or more

Exclusion Criteria:

* Diagnosis of asthma
* Predicted life expectancy of less than 3 years
* History of hypersensitivity to macrolide antibiotics
* Long-term kidney insufficiency
* Long-term liver insufficiency
* Prolonged QT interval
* Use of medications that may prolong the QT interval
Effects of Tablet Computer-based Cognitive Training in Patients With Idiopathic REM Sleep Behavior Disorder

To evaluate the effectiveness of tablet computer-based cognitive training in patients with idiopathic REM sleep behavior disorder.

Rapid eye movement (REM) sleep behavior disorder (RBD) is a parasomnia characterized by abnormal movement to reproduce dreams and loss of skeletal muscle tension during REM sleep. Idiopathic RBD (iRBD) refers to the absence of any predisposing factors or comorbid neurological disorders. iRBD is considered the prodromal stage of alpha-synucleinopathy.

Through past studies, it has been confirmed that cognitive function decline has already occurred in a significant number of iRBD patients. However, there is still no treatment that can suppress or delay the onset of neurodegenerative diseases.

The cognitive function improvement effect of computerized cognitive training in the elderly and patients with mild cognitive impairment is known. However, the effect of cognitive training on improving cognitive function in iRBD patients has not been studied.

The investigators developed a program that allows patients to train cognitive functions in various domains by repeatedly performing tasks related to daily life activities. In addition, by loading the program on the tablet computer, it is possible to participate in the training easily at home using the touch screen without visiting the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 60-80 years old who have been diagnosed with iRBD through nocturnal polysomnography according to the International Classification of Sleep Disorders 3rd Edition (ICSD-3) diagnostic criteria
* Those who gave their written consent to participate in the study

Exclusion Criteria:

* Patients with neurodegenerative diseases including Parkinson's disease, dementia, and multiple system atrophy
* Patients with secondary causes of RBD
* Patients with severe hearing, visual impairment, or motor impairment
* Patients who have received cognitive training within the last year
Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use- Electronic Spanish Platform

The goal of this study is to validate the TAPS-ESP as a screen and assessment that can be used in primary care for the screening and treatment of substance use.

This Phase II study seeks to conduct further research to validate the TAPS-ESP as a Spanish language version of the screening and brief assessment and pave the way for its broad dissemination in the healthcare system. The investigators will use a novel application of a Type 1 hybrid effectiveness-implementation design, adapted to a screening validation study. The investigators will conduct a large-scale study to validate the TAPS-ESP against established diagnostic and biomarker metrics, replicating the design of the seminal English-language TAPS study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Current patient of the clinic
* Spanish-language preferred
* Ability to read Spanish

Exclusion Criteria:

* Unable to provide informed consent
* Inability to comprehend or read Spanish
* Inability to self-administer the iPad tool due to physical limitations