cyrilzakka/clinical-trials huggingface dataset:
Individualized Music Playlist Based on ISO Principle for De-escalation of Agitation in Dementia

The goal of this clinical trial is to evaluate the efficacy of an Individualized Music Playlist (InMP) composed of preferred music genres sequenced according to the ISO-Principle, for the immediate de-escalation of agitation in dementia, compared with preferred music (PM) and treatment as usual (TAU).

1. Study design

   - Randomized controlled trial
2. Participants

   - Eighty-one older adults living with dementia and demonstrate significant agitation
3. Setting:

   - Residential care home
4. Intervention

   - Individualized music listening intervention played with an iPad and a wireless neckband speaker for 30 minutes when agitation begins in addition to usual care.
5. Comparison conditions

   * Preferred music listening group: Preferred music listening played with an iPad and a wireless neckband speaker for 30 minutes when agitation begins in addition to usual care.
   * Usual care group: usual care
6. Outcomes

   * Level of agitation measured with the Pittsburgh Agitation Scale
   * Intensity of agitation measured with the Positive and Negative Syndrome Scale - Excited Component
   * Agitation occurrence frequency measured with Cohen-Mansfield Agitation Inventory
   * Distress of formal caregivers related to agitation measured with Neuropsychiatric Inventory
7. Focus group interviews with the care staff will be conducted as a process evaluation for identifying the potential facilitators and barriers related to implementation.

Eligibility Criteria:
Inclusion Criteria:

* residents in long-term care facilities
* diagnosed with any type of dementia
* presented with significant agitation

Exclusion Criteria:

* had been admitted to the facility for less than three months
* are participating in other studies or experimental therapies
* have a comorbid psychiatric illness
* have physical illness that prevents them from listening to music
Supporting Young Women's Reproductive Health by Harnessing Prosociality Among Drug Shopkeepers

The goal of the study is to operationalize and test the preliminary impact of providing regular customer feedback from adolescent girls and young women (AGYW) to drug shopkeepers on the distribution of contraceptives and HIV self-testing to AGYW over 18 months.

The investigators will cross-randomize 120 drug shops enrolled in the parent Malkia Klabu effectiveness cluster-randomized controlled trial (CRCT; NCT05357144), stratified by CRCT study arm, to one of three initial conditions: 1. No feedback. AGYW customer feedback will be collected, but not shared with the shopkeeper. 2. Private feedback. Biweekly summarized reports of AGYW customer feedback will be given directly to shopkeepers. 3. Public feedback: Shopkeepers will get biweekly summarized reports of AGYW customer feedback, gold stars reflecting the level of AGYW customer feedback (e.g., 1-5 star rating) will be placed in the shop in a visible location, and shopkeepers will be invited to an awards ceremony every 6 months to recognize shopkeepers who receive high levels of positive AGYW customer feedback. The investigators will phase in the 2 interventions (Private and Public Feedback) on a staggered basis to control for both shop-specific and time-specific trends for the primary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Shopkeepers enrolled in the parent CRCT

Exclusion Criteria:

* None
Extension Phase of the Chronicle® Offers Management to Patients With Advanced Signs & Symptoms of Heart Failure Study

The purpose of the Extension Phase of the COMPASS-HF study is to continue to observe the safety of the Chronicle® Implantable Hemodynamic Monitor (IHM) system and Chronicle ICD system and provide study doctors continued access to the heart pressure information recorded by the Chronicle devices which may be used to help manage heart failure. The Extension Phase of the COMPASS-HF study is limited to people who have already received the investigational system and are currently enrolled in a Chronicle IHM or ICD study.

For the purpose of the Extension Phase, the Chronicle IHM and ICD systems are for continued use in patients with moderate to severe heart failure and are intended to monitor hemodynamic information, including right ventricular and pulmonary artery pressures, heart rate and activity. The COMPASS-HF Extension Phase includes the following Chronicle IHM studies:

* The Chronicle IHM Phase I/II study, which was a 148 patient technology assessment study that began enrolling patients in 1998 and completed the endpoint driven follow up period of 3 months for safety and 12 months for efficacy in 2002
* The Chronicle Offers Management to Patients with Advanced Signs \& Symptoms of Heart Failure (COMPASS-HF) study, which was a 274 patient randomized study that began enrolling patients in 2003 and completed the endpoint driven follow up period of 6 months in 2005
* The Pulmonary Arterial Hypertension Pilot (PAH Pilot) study, which was a 24 patient pilot study that began enrolling patients in 2003 and completed the endpoint driven follow up period of 12 weeks in 2006
* The Reducing Decompensation Events Utilizing intraCardiac Pressures in Patients with Chronic HF (REDUCEhf) study, which was a 400 patient randomized study that began enrolling patients in 2006 and completed endpoint driven follow up period of 12 months in 2010.

In all four studies, patients were implanted with a Chronicle IHM or ICD system and upon completion of the endpoint driven follow up period, entered long term follow up and have continued to be seen every six months for study visits.

As the Chronicle IHM or ICD system has not received U.S. Food and Drug Administration approval, the COMPASS-HF Extension Phase is being initiated as a means to allow continued access of Chronicle IHM data to study investigators in one concurrently enrolled study and follow up schedule. No additional study objectives or new enrollments will be captured in the COMPASS-HF Extension Phase.

Eligibility Criteria:
Inclusion Criteria:

* Patient provides written informed consent for the Extension Phase
* Patient has an implanted Chronicle IHM or ICD device and is actively enrolled in one of the following studies: COMPASS-HF, Chronicle IHM Phase I/II, REDUCEhf or the PAH Pilot Study

Exclusion Criteria:

* Patient unwilling to transmit their Chronicle IHM or ICD device data as directed by their study clinicians or unwilling to participate in protocol scheduled follow up visits (every six months)
A Double-blind Placebo Controlled Trial of Sentra PM, a Medical Food

This is a double blind placebo controlled study of one hundred and four subjects which will be randomized for treatment with Sentra PM alone, Sentra PM with trazadone, trazadone alone and placebo alone. Twenty -six subjects will be randomly placed in one of the four groups. Each of the one hundred and four subjects will undergo baseline examination to include a sleep study questionnaires and 24- hour electrocardiographic recording. The one hundred and four subjects will then be randomly placed in one of the four groups.

Sentra PM can induce restorative sleep compared to placebo, and as good as a sleep drug (trazadone) in subjects experiencing non-restorative sleep. Sentra PM taken with trazadone works better than either product alone. Twenty-six subjects will be randomized to a two week ingestion of Sentra PM at bedtime, twenty-six subjects will be randomized to a two week ingestion of trazadone at bedtime, twenty-six subjects will be randomized to a two week ingestion of Sentra PM with trazadone at bedtime and twenty -six subjects will be randomized to a two week ingestion of placebo at bedtime. Each morning after ingestion of either active product or placebo, the subject will fill out sleep questionnaires. On the fourteenth day of ingestion, a repeat 24-Hour ECG examination will be performed on all one hundred and four subjects and each subject will give a second blood sample for analysis. On the morning of the 14th day of ingestion the final sleep questionnaires will be completed.

Eligibility Criteria:
Inclusion Criteria:

* Males and females over the age of 18 and below age 65.
* Patients with a history of a sleep disturbance with non-restorative sleep defined by perceived increase in sleep latency or morning/daytime grogginess.

Exclusion Criteria:

* Subjects who have previously taken GABAdone, SentraPM or trazadone.
* Subjects who are currently taking tricyclic anti-depressants.
* Any blood chemistry anomalies the investigator finds that may put the patient at risk or invalidate study results.
* Pregnant or lactating females.
* Subjects with implanted pacemakers or other implanted electrical devices
(EASY)-IMProving Adherence to Clopidogrel Trial (IMPACT))

The purpose of this study is to test the impact of a multidisciplinary approach to improve the adhesion and persistence to Clopidogrel therapy. A simple and inexpensive therapy management involving a tighter monitoring of patients by nurses and pharmacists will improve the persistence and adhesion to Clopidogrel and Aspirin after the implantation of drug-eluting stents.

Optimal treatment with Clopidogrel and Aspirin is critical for preventing complications after implantation of drug-eluting stents (DES). The premature cessation of Clopidogrel is a well recognized factor of thrombosis of stents, especially DES. Indeed, there remains a large portion of patients that prematurely stop clopidogrel. No study has demonstrated that a therapeutic management program could improve patient compliance to their antiplatelets. Through an open-label clinical study, two groups of patients who just received their DES will be compared: one with the usual protocol (consisting of seeing the cardiologist 6 weeks after the intervention) and one with the normal care supplemented by a simple and efficient follow-up (consisting of phone calls at 7 days, 1 month, 6 months and 9 months explaining the importance of antiplatelet therapy, evaluating the health of the patient and well received prescription from the pharmacy). Patients in both groups will receive a prescription to Clopidogrel and Aspirin (for 1 month), with 11 renewals.

Eligibility Criteria:
Inclusion Criteria:

* Percutaneous Coronary Intervention with implantation of Drug-Eluting Stent
* Prescription for Plavix and Aspirin

Exclusion Criteria:

* Patients frequenting more than one pharmacy
Cross-Cultural Use of Performance-Based Functional Assessment in Alzheimer's Disease

This study plans to assess the effectiveness of performance-based functional assessments (PBFAs) and cognitive assessments in diagnosing Alzheimer's disease in Hispanic/Latino populations. The information from this study will be analyzed with data from the Rocky Mountain Alzheimer's Disease Center Bio-AD study (NCT02612376).


Eligibility Criteria:
Inclusion Criteria:

* Persons with age-related MCI or AD according to clinical diagnosis, consistent with National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria
* Community-dwelling controls
* Age \> 55 years
* Have been enrolled and completed at least one visit in the Bio-AD study and consent to access their data (the Rocky Mountain Alzheimer's Disease Center Bio-AD study (clinicaltrials.gov identifier: NCT02612376))
* Have capacity to provide consent; capacity will be assessed at the time of consent
* Ability to complete baseline assessments
* Has informant (study partner) available to complete functional interviews/survey measures

Exclusion Criteria:

* Presence of concomitant medical, neurological, or psychiatric illness or condition that in the opinion of the investigators would confound interpretation of study results. These include:
* Korsakoff encephalopathy;
* active substance abuse;
* hepatitis C;
* opportunistic brain infection;
* brain tumor;
* active neoplastic disease (skin tumors other than melanoma are not exclusionary; participants with stable prostate cancer may be included at the discretion of the project director);
* multiple sclerosis;
* history of clinically significant stroke;
* current evidence or history in the past 2 years of

  * focal brain lesion,
  * head injury with loss of consciousness in the past year, or
  * DSM-5 criteria for any major psychiatric disorder, including

    1. psychosis,
    2. uncontrolled major depression,
    3. bipolar disorder,
    4. alcohol or substance abuse;
    5. blindness,
    6. deafness or
    7. any other disability which may prevent the participant from participating or cooperating in the protocol.
* Prisoners
* Any contraindication for MRI
Water Method Colonoscopy in Patients With Prior Surgery

Water method with water exchange has been shown to reduce medication requirement and pain experienced during colonoscopy. It increases the success rate of cecal intubation in sedated and unsedated patients undergoing screening colonoscopy. Exchange of water during scope insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion of air from the colon during insertion by omission of air insufflations and suction removal of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy insertion in average patients and may enhance the success of difficult colonoscopy.

Prior abdominal or pelvic surgery is an independent factor for difficult colonoscopy, the probable adhesion may change the anatomy and increase the discomfort of patients. We postulate that these patients may benefit from using the water method for colonoscopy. In this proposal we test the hypothesis that compared with conventional air insufflations the water method with water exchange significantly enhances the success rate of cecal intubation in patients with prior abdominal or pelvic surgery.

The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in patients with prior abdominal or pelvic surgery. The primary outcome is cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.


Eligibility Criteria:
Inclusion Criteria:

* Patients with prior abdominal or pelvic surgery,

Exclusion Criteria:

* History of colorectal surgery
* Severe colonic stricture or obstructing tumor
* Patients who cannot give informed consent and those who are hemodynamically unstable
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IGNX001

The goal of this randomized, double-blind, placebo-controlled, single ascending dose clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IGNX001 in peanut-allergic adults and older Adolescents.


Eligibility Criteria:
Key Inclusion Criteria:

* History of physician-diagnosed peanut allergy with clinical reaction to peanut within 2 hours of exposure to peanut or peanut-containing food (within the last 15 years).
* Peanut specific IgE level ≥ 1 kUA/L.
* Positive peanut SPT with wheal diameter ≥ 5 mm.

Key Exclusion Criteria:

* History of severe or life-threatening anaphylaxis requiring intubation or admission to intensive care unit within 1 year prior to Screening.
* Current, or within the past year, treatment with food allergen immunotherapy or participation in a food allergy immunotherapy study.
* Current treatment with aeroallergen immunotherapy, except if on stable monthly maintenance SC aeroallergen immunotherapy.
The Effectiveness of Prolotherapy (%5 Dextros) in the Treatment of Patients With Chondromalacia Patella

Dextrose prolotherapy is a form of treatment in which hypertonic dextrose solution is used as a stimulant solution and regeneration is increased by stimulating the body's natural healing mechanisms after injection.

The aim of this study is to compare the dextrose prolotherapy applied with home exercise program and saline injections as a control group in patients who applied to our clinic with knee pain and diagnosed with chondromalacia patella, and to investigate the effectiveness of dextrose and saline on the job to determine the superiority of the injections to each other.

The study was designed as prospective, randomized, controlled trial. 48 people who met the inclusion criteria were randomized into two groups of 24 people. The first group will be designated as Dextrose Prolotherapy Group and dextrose prolotherapy and exercise program will be applied to these patients. Patients in the second group will be designated as the Serum Physiological Group, and injections with saline and home exercise program will be applied in accordance with the prolotherapy protocol.Participants were evaluated with Visual Analogue Scale (VAS), Patello Femoral Pain Severity Scale (PFPSS), Kuala Patellofemoral Scoring System (KPSS) and Short Form 36 (SF-36).Knee cartilage thickness measurements and the presence of suprapatellar effusion of the participants whose evaluations are completed will be evaluated bilaterally by ultrasonography and the findings will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Female / male aged\> 18 years
* Diagnosis of chondromalacia patella after physical examination and imaging (direct radiography, MRI)
* Those whose symptoms persist\> 3 months
* Does not have a disease that will prevent him from exercising
* Participation in the study voluntarily and regularly

Exclusion Criteria:

* Pregnant patients
* History of previous knee surgery
* Having received physical therapy from the knee area in the last 3 months
* Drug allergy
* Previous prolotherapy or any injection up to 3 months ago
* Those with pain reflected from waist or hip
* Patients with neuropathic pain
* Tumor, infectious, psychiatric illness, history of bleeding diathesis
* Having a trauma history in the last 6 months
* Those with systemic diseases such as diabetes, hepatitis, coagulopathy
* Those with cerebrovascular event disease in which bleeding continues actively
* Those who received NSAID treatment within the last week
* Patients with a BMI\> 40
* Finding leg length difference
Effects of Training and Detraining on Postmenopausal Breast Cancer Survivors

The present study aimed to verify the effects of resistance exercise training and successive detraining on body composition, lipid profile, muscle strength, oxidative stress, and inflammatory markers of postmenopausal breast cancer survivors undergoing tamoxifen treatment.

The present study aimed to verify the effects of 12 weeks of resistance exercise training and successive 12 weeks of detraining on body composition (Body Mass, Body Mass Index, Fat Mass, and Fat-Free Mass), lipid profile (Triglycerides, Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol), muscle strength (1RM test), oxidative stress (Thiobarbituric acid reactive substances,Non-Protein Thiols, Catalase activity, and Superoxide Dismutase), and inflammatory markers (Interferon γ, Tumor Necrosis Factor α, interleukin 6 , Adiponectin, and Interleukin 4) of postmenopausal breast cancer survivors undergoing tamoxifen treatment.

Eligibility Criteria:
Inclusion Criteria:

* 1) age between 40 and 65 years; 2) stage 0-IIIA Breast Cancer; 3) submission to axillary lymphadenectomy); 4) completion of chemotherapy and radiation therapy at least 6 months before the study; 5) lack of participation in supervised physical exercise programs in the six months before the beginning of the research; 6) absence of a problem and/or musculoskeletal limitation that would prevent the performance of the proposed exercises; 7) release by a medical professional to participate in the physical training program; 8) residency in Uberlândia

Exclusion Criteria:

* missing more than 20% of the exercise sessions; unable to perform the proposed training protocols; change in drug therapy during the intervention.
Efficacy of Narrow Band Spectrum Endoscopy for the Diagnosis of Gastric Antral Vascular Ectasia in Patients With Liver Cirrhosis

the study aims to evaluate the role of similar technology of Narrow Band Imaging VIST video intelligent staining technology in the diagnosis of Gastric Antral Vascular ectasia in cirrhotic patients

VIST (Video intelligent staining technology) is used to the diagnosis of GAVE as the form of ectatic vessels in the antrum in instead of erosions in the antrum by White light endoscopy which can mislead the diagnosis to Portal hypertension gastropathy. Targeted biopsies are taken and examined histopathologically in order to see if matching with VIST view. In addition, CD61 is used to highlight the diagnosis for more confirmation. CD61 is an immunohistochemistry platelets marker.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mucosal vascular lesions at the gastric antrum suspicious of GAVE of a linear striped form or a diffuse punctate form upon conventional WLE

Exclusion Criteria:

* Connective tissue disorders like systemic sclerosis.
* Chronic kidney disease.
* Recent use of proton pump inhibitors in the last 14 days.
* History of gastric surgery or gastric cancer.
* Pernicious anemia.
* Recent history of non-steroidal anti-inflammatory drugs intake
Mucin Concentration in Sputum From COPD Patients During a Pulmonary Exacerbation

chronic obstructive pulmonary disease (COPD) is typically associated with mucus hypersecretion in the airways. In health, mucin is the major macromolecular component and is responsible for the protective and clearance properties of the mucus gel. In a recent study the investigators found that mucins are decreased and unstable in the sputum of adult cystic fibrosis (CF) patients.

In this study the investigators want to investigate the differences on the mucin quantity and quality of airway secretions during pulmonary exacerbation of patients with COPD.

We hypothesize that during an exacerbation the mucin amount is increasing.

The aim of this study is to evaluate the molecular (mucins) and structure properties (mucin-stability) of the airway secretions in COPD related to the severity of the disease.

We characterize sputum composition of patients with pulmonary exacerbations. Using gel electrophoresis, with specific antibodies we will analyze MUC5AC and MUC5B mucins.

The significance of these studies is that they will give us novel information about the pathogenesis of chronic inflammatory airway diseases, provide tools for assessing the progression of lung disease, and most critically, will identify novel opportunities and targets for therapeutic intervention.

Eligibility Criteria:
Inclusion Criteria:

* forced expiratory volume at one second (FEV1) \< 80%
* sputum production
* clinical likely hood of exacerbation

Exclusion Criteria:

* FEV1 \> 80% or \< 30%
* increased systemic inflammation
* susceptibility of pneumonia
* need for antibiotic treatment